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HOMEFOOD randomised trial - Six-month nutrition therapy improves quality of life, self-rated health, cognitive function, and depression in older adults after hospital discharge.
Blondal, BS, Geirsdottir, OG, Halldorsson, TI, Beck, AM, Jonsson, PV, Ramel, A
Clinical nutrition ESPEN. 2022;48:74-81
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It is well known that older people are at a higher risk for nutritional inadequacy which is accompanied by depression, impaired cognitive function, and poor overall health. In this secondary analysis of a randomised controlled assessor-blinded dietary intervention trial, the authors examined the effects of six months of nutritional therapy on quality of life, self-rated health, cognitive function, and depression in elderly patients aged 65 years and over. The participants in the intervention group received nutritional therapy (HOMEFOOD) education to overcome malnutrition, which included dietary recommendations to ensure an adequate nutritional intake of energy and protein through diet and additional supplemental protein and energy-rich foods. After six months of nutritional therapy, the intervention group showed improvement in cognitive function, self-rated health, depression score, and quality of life scores, as well as improvements in measures related to weight gain. Further studies need to be conducted in order to determine if nutritional therapy provides additional benefits to older people. However, healthcare professionals can use the results of this study to better understand how nutritional therapy can improve the quality of life and health of older people in comparison to standard care, so they can better advise their patients.
Abstract
BACKGROUND AND AIMS Malnutrition is common among older adults and is related to quality of life, cognitive function, and depression. To what extent nutrition interventions can improve these outcomes remains unclear. The aim of this study was to investigate the effect of nutrition therapy on health-related quality of life (EQ-5D), self-rated health, cognitive function, and depression in community dwelling older adults recently discharged from hospital. METHODS Participants (>65 years) were randomised into an intervention (n = 53) and a control group (n = 53). The intervention group received individualised nutrition therapy based on the nutrition care process including 5 home visits and 3 phone calls, in combination with freely delivered energy- and protein-rich foods and oral nutrition supplements for six months after hospital discharge. EQ-5D, self-rated health, Mini-Mental-State-Examination (MMSE), and the Centre for Epidemiologic Studies Depression - IOWA (CES-D) scale were measured at baseline and at endpoint. RESULTS Two subjects dropped out, one from each arm. The control group experienced an increase in depressive symptoms and a decrease in self-rated health during the study period, while the intervention group experienced increases in cognitive function, self-rated health, and EQ-5D resulting in significant endpoint differences between the groups: EQ-5D (0.102, P = 0.001); self-rated health: 15.876 (P < 0.001); MMSE 1.701 (P < 0.001); depressive symptoms: - 3.072 (P < 0.001); all in favour of the intervention group. Improvements during the intervention in MMSE, self-rated health, and CES-D were significantly related to body weight gain in a linear way. CONCLUSION Cognitive function and mental well-being worsen or stagnate in older adults who receive standard care after hospital discharge. However, a six-month nutrition therapy improves these outcomes leading to statistically and clinically significant endpoint differences between the groups. As improvements were related to body weight gain after hospital discharge, we conclude that the increase in dietary intake, with focus on energy and protein density, and changes in body weight might have contributed to better cognitive function and mental well-being in older adults after the intervention.
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Lactobacillus rhamnosus CNCM I-3690 decreases subjective academic stress in healthy adults: a randomized placebo-controlled trial.
Wauters, L, Van Oudenhove, L, Accarie, A, Geboers, K, Geysen, H, Toth, J, Luypaerts, A, Verbeke, K, Smokvina, T, Raes, J, et al
Gut microbes. 2022;14(1):2031695
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Previous research has shown a bidirectional relationship between the gut and psychological stress, which could be mediated by intestinal permeability followed by an immune and inflammatory response. However, the exact mechanisms of this relationship are yet to be elucidated. This randomised, double-blind, placebo-controlled trial evaluated the beneficial effects of Lactobacillus rhamnosus CNCM I-3690 on intestinal permeability and stress markers during a public speech in healthy students. Participants consumed either milk containing Lactobacillus rhamnosus CNCM I-3690 or acidified milk twice daily for four weeks to assess subjective and objective stress markers and markers of intestinal permeability. Lactobacillus rhamnosus CNCM I-3690 reduced the stress-induced hyperpermeability to mannitol and subjective stress markers (State-Trait Anxiety Inventory/ STAI). A subgroup of healthy students with stress-induced cortisol >P90 of baseline showed a reduction in perceived stress score following Lactobacillus rhamnosus CNCM I-3690 intervention. To evaluate the additional effects of Lactobacillus rhamnosus CNCM I-3690 on stress and gut health, further robust studies are needed. Healthcare professionals can use the findings of this study to understand the anxiolytic effects of Lactobacillus rhamnosus CNCM I-3690.
Abstract
Psychological stress negatively affects the intestinal barrier function in animals and humans. We aimed to study the effect of Lactobacillus rhamnosus CNCM I-3690 on intestinal permeability and stress-markers during public speech. Healthy students were randomized to L. rhamnosus-containing (test) or acidified (placebo) milk consumed twice daily for 4 weeks, with 46 subjects per treatment group. Small intestinal permeability was quantified by a 2 h urinary lactulose-mannitol ratio (LMR, primary outcome), fractional excretion of lactulose (FEL) and mannitol (FEM). Salivary cortisol, State-Trait Anxiety Inventory (STAI) and Perceived Stress scores (PSS) were collected. No between-treatment differences were found for LMR (p = .71), FEL or FEM. Within-treatment analyses showed similar LMR and FEL but a stress-induced increase of FEM with the placebo (p < .05) but not test product. Despite a similar increase in salivary cortisol, the stress-induced increase in STAI was significantly lower with the test product vs. placebo (p = .01). Moreover, a stress-preventative effect of the probiotic was found for PSS and more pronounced in subjects with high stress-induced cortisol (p = .01). While increased FEM was mediated by salivary cortisol levels, the effect of the test product on subjective stress was not mediated by changes in FEM. No serious adverse events occurred. In conclusion, we demonstrated that L. rhamnosus CNCM I-3690 prevented stress-induced hyperpermeability to mannitol. Subjective but not objective stress-markers were reduced with L. rhamnosus vs. placebo, suggesting anxiolytic effects, which were independent of barrier stabilization and attractive for the reduction of stress in both health and disease. Clinicaltrials.gov, number NCT03408691.
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Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial.
Rein, M, Ben-Yacov, O, Godneva, A, Shilo, S, Zmora, N, Kolobkov, D, Cohen-Dolev, N, Wolf, BC, Kosower, N, Lotan-Pompan, M, et al
BMC medicine. 2022;20(1):56
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Type 2 diabetes mellitus (T2DM) affects around 10% of the global population. The primary goal in its management is to improve glycemic control. Modifying the diet can help, but many patients fail to achieve improvements with diet alone. The aim of the randomized dietary intervention pilot trial is to evaluate the effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in 23 adults with newly diagnosed T2DM, as compared to the commonly recommended Mediterranean-style (MED) diet. The PPT diet led to significant lower levels of continuous-glucose-monitoring (CGM)-based measures as compared to the MED diet. In the additional 6-months intervention, metabolic parameters were further improved and 61% of the participants exhibited diabetes remission. Improvements in clinical outcomes were also accompanied by changes in the gut microbiome. These findings may be useful for the design of larger studies in the future that may have implications for dietary advice in clinical practice.
Abstract
BACKGROUND Dietary modifications are crucial for managing newly diagnosed type 2 diabetes mellitus (T2DM) and preventing its health complications, but many patients fail to achieve clinical goals with diet alone. We sought to evaluate the clinical effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in individuals with newly diagnosed T2DM as compared to the commonly recommended Mediterranean-style (MED) diet. METHODS We enrolled 23 adults with newly diagnosed T2DM (aged 53.5 ± 8.9 years, 48% males) for a randomized crossover trial of two 2-week-long dietary interventions. Participants were blinded to their assignment to one of the two sequence groups: either PPT-MED or MED-PPT diets. The PPT diet relies on a machine learning algorithm that integrates clinical and microbiome features to predict personal postprandial glucose responses (PPGR). We further evaluated the long-term effects of PPT diet on glycemic control and metabolic health by an additional 6-month PPT intervention (n = 16). Participants were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using a smartphone application. RESULTS In the crossover intervention, the PPT diet lead to significant lower levels of CGM-based measures as compared to the MED diet, including average PPGR (mean difference between diets, - 19.8 ± 16.3 mg/dl × h, p < 0.001), mean glucose (mean difference between diets, - 7.8 ± 5.5 mg/dl, p < 0.001), and daily time of glucose levels > 140 mg/dl (mean difference between diets, - 2.42 ± 1.7 h/day, p < 0.001). Blood fructosamine also decreased significantly more during PPT compared to MED intervention (mean change difference between diets, - 16.4 ± 37 μmol/dl, p < 0.0001). At the end of 6 months, the PPT intervention leads to significant improvements in multiple metabolic health parameters, among them HbA1c (mean ± SD, - 0.39 ± 0.48%, p < 0.001), fasting glucose (- 16.4 ± 24.2 mg/dl, p = 0.02) and triglycerides (- 49 ± 46 mg/dl, p < 0.001). Importantly, 61% of the participants exhibited diabetes remission, as measured by HbA1c < 6.5%. Finally, some clinical improvements were significantly associated with gut microbiome changes per person. CONCLUSION In this crossover trial in subjects with newly diagnosed T2DM, a PPT diet improved CGM-based glycemic measures significantly more than a Mediterranean-style MED diet. Additional 6-month PPT intervention further improved glycemic control and metabolic health parameters, supporting the clinical efficacy of this approach. TRIAL REGISTRATION ClinicalTrials.gov number, NCT01892956.
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Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial.
Ebbeling, CB, Knapp, A, Johnson, A, Wong, JMW, Greco, KF, Ma, C, Mora, S, Ludwig, DS
The American journal of clinical nutrition. 2022;115(1):154-162
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Diets high in carbohydrates and particularly processed carbohydrates can increase the risk for developing a dysfunction in the body’s ability to take up sugar from the blood, known as insulin resistance. However how this relates to insulin resistance can contribute to the development of many diseases such as type 2 diabetes, heart disease and stroke, which highlights the importance in preventing this dysfunction. This randomised control trial of 148 individuals aimed to determine the role of low, medium, and high carbohydrate diets with varying saturated fat content on measures for insulin resistance. The results showed that regardless of the fat content, it was the level of carbohydrate that determined the effect on measures of insulin resistance. High saturated fat and low-carbohydrate diets improved insulin resistance and low saturated fat high carbohydrate diets worsened insulin resistance. Improvements were also observed in blood lipids with a high fat low carbohydrate diet. It was concluded that a diet low in carbohydrates, but high in saturated fat improved insulin resistance and blood lipid levels. This study could be used by healthcare professionals to understand that a diet, which replaces fat with carbohydrates may be worsening insulin resistance and that low carbohydrate diets may be of benefit.
Abstract
BACKGROUND Carbohydrate restriction shows promise for diabetes, but concerns regarding high saturated fat content of low-carbohydrate diets limit widespread adoption. OBJECTIVES This preplanned ancillary study aimed to determine how diets varying widely in carbohydrate and saturated fat affect cardiovascular disease (CVD) risk factors during weight-loss maintenance. METHODS After 10-14% weight loss on a run-in diet, 164 participants (70% female; BMI = 32.4 ± 4.8 kg/m2) were randomly assigned to 3 weight-loss maintenance diets for 20 wk. The prepared diets contained 20% protein and differed 3-fold in carbohydrate (Carb) and saturated fat as a proportion of energy (Low-Carb: 20% carbohydrate, 21% saturated fat; Moderate-Carb: 40%, 14%; High-Carb: 60%, 7%). Fasting plasma samples were collected prerandomization and at 20 wk. Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). Other outcomes included lipoprotein(a), triglycerides, HDL cholesterol, LDL cholesterol, adiponectin, and inflammatory markers. Repeated measures ANOVA was used for intention-to-treat analysis. RESULTS Retention was 90%. Mean change in LPIR (scale 0-100) differed by diet in a dose-dependent fashion: Low-Carb (-5.3; 95% CI: -9.2, -1.5), Moderate-Carb (-0.02; 95% CI: -4.1, 4.1), High-Carb (3.6; 95% CI: -0.6, 7.7), P = 0.009. Low-Carb also favorably affected lipoprotein(a) [-14.7% (95% CI: -19.5, -9.5), -2.1 (95% CI: -8.2, 4.3), and 0.2 (95% CI: -6.0, 6.8), respectively; P = 0.0005], triglycerides, HDL cholesterol, large/very large TRL-P, large HDL-P, and adiponectin. LDL cholesterol, LDL-P, and inflammatory markers did not differ by diet. CONCLUSIONS A low-carbohydrate diet, high in saturated fat, improved insulin-resistant dyslipoproteinemia and lipoprotein(a), without adverse effect on LDL cholesterol. Carbohydrate restriction might lower CVD risk independently of body weight, a possibility that warrants study in major multicentered trials powered on hard outcomes. The registry is available through ClinicialTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02068885.
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Dietary carbohydrate restriction augments weight loss-induced improvements in glycaemic control and liver fat in individuals with type 2 diabetes: a randomised controlled trial.
Thomsen, MN, Skytte, MJ, Samkani, A, Carl, MH, Weber, P, Astrup, A, Chabanova, E, Fenger, M, Frystyk, J, Hartmann, B, et al
Diabetologia. 2022;65(3):506-517
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The carbohydrate restricted diet has been shown to be beneficial for Type 2 diabetes (T2D) management and reducing cardiovascular disease risk. This open-label, parallel randomised controlled trial involved Type 2 diabetic patients taking antidiabetic medications who restricted their energy intake by following either a carbohydrate-reduced high protein diet or a conventional diabetic diet. Participants in both groups had a 5.9% reduction in body weight, similar changes in fasting NEFA, apoB, apoA-1, total cholesterol, LDL-cholesterol, HDL-cholesterol, and non-HDL cholesterol, and a significant reduction in fasting glucose, insulin, C-peptide, and HOMA2-IR after 6 weeks of intervention. Carbohydrate-reduced high protein diet group showed a greater reduction in HbA1c and diurnal mean glucose, glycaemic variability, fasting triacylglycerol concentration and liver fat content. Carbohydrate-reduced high protein diet caused an adverse reaction in some patients, and those following a carbohydrate-reduced high protein diet excreted more urea than those eating a conventional diabetic diet. To confirm the results of this study, long-term robust studies are needed. This study can assist healthcare professionals in understanding the benefits of following a carbohydrate-reduced high protein diet in improving glycaemic control, triglyceride levels, and reducing body weight in Type 2 diabetes patients.
Abstract
AIMS/HYPOTHESIS Lifestyle modification and weight loss are cornerstones of type 2 diabetes management. However, carbohydrate restriction may have weight-independent beneficial effects on glycaemic control. This has been difficult to demonstrate because low-carbohydrate diets readily decrease body weight. We hypothesised that carbohydrate restriction enhances the beneficial metabolic effects of weight loss in type 2 diabetes. METHODS This open-label, parallel RCT included adults with type 2 diabetes, HbA1c 48-97 mmol/mol (6.5-11%), BMI >25 kg/m2, eGFR >30 ml min-1 [1.73 m]-2 and glucose-lowering therapy restricted to metformin or dipeptidyl peptidase-4 inhibitors. Participants were randomised by a third party and assigned to 6 weeks of energy restriction (all foods were provided) aiming at ~6% weight loss with either a carbohydrate-reduced high-protein diet (CRHP, percentage of total energy intake [E%]: CH30/P30/F40) or a conventional diabetes diet (CD, E%: CH50/P17/F33). Fasting blood samples, continuous glucose monitoring and magnetic resonance spectroscopy were used to assess glycaemic control, lipid metabolism and intrahepatic fat. Change in HbA1c was the primary outcome; changes in circulating and intrahepatic triacylglycerol were secondary outcomes. Data were collected at Copenhagen University Hospital (Bispebjerg and Herlev). RESULTS Seventy-two adults (CD 36, CRHP 36, all white, 38 male sex) with type 2 diabetes (mean duration 8 years, mean HbA1c 57 mmol/mol [7.4%]) and mean BMI of 33 kg/m2 were enrolled, of which 67 (CD 33, CRHP 34) completed the study. Body weight decreased by 5.8 kg (5.9%) in both groups after 6 weeks. Compared with the CD diet, the CRHP diet further reduced HbA1c (mean [95% CI] -1.9 [-3.5, -0.3] mmol/mol [-0.18 (-0.32, -0.03)%], p = 0.018) and diurnal mean glucose (mean [95% CI] -0.8 [-1.2, -0.4] mmol/l, p < 0.001), stabilised glucose excursions by reducing glucose CV (mean [95% CI] -4.1 [-5.9, -2.2]%, p < 0.001), and augmented the reductions in fasting triacylglycerol concentration (by mean [95% CI] -18 [-29, -6]%, p < 0.01) and liver fat content (by mean [95% CI] -26 [-45, 0]%, p = 0.051). However, pancreatic fat content was decreased to a lesser extent by the CRHP than the CD diet (mean [95% CI] 33 [7, 65]%, p = 0.010). Fasting glucose, insulin, HOMA2-IR and cholesterol concentrations (total, LDL and HDL) were reduced significantly and similarly by both diets. CONCLUSIONS/INTERPRETATION Moderate carbohydrate restriction for 6 weeks modestly improved glycaemic control, and decreased circulating and intrahepatic triacylglycerol levels beyond the effects of weight loss itself compared with a CD diet in individuals with type 2 diabetes. Concurrent differences in protein and fat intakes, and the quality of dietary macronutrients, may have contributed to these results and should be explored in future studies. TRIAL REGISTRATION ClinicalTrials.gov NCT03814694. FUNDING The study was funded by Arla Foods amba, The Danish Dairy Research Foundation, and Copenhagen University Hospital Bispebjerg Frederiksberg.
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Diet and food type affect urinary pesticide residue excretion profiles in healthy individuals: results of a randomized controlled dietary intervention trial.
Rempelos, L, Wang, J, Barański, M, Watson, A, Volakakis, N, Hoppe, HW, Kühn-Velten, WN, Hadall, C, Hasanaliyeva, G, Chatzidimitriou, E, et al
The American journal of clinical nutrition. 2022;115(2):364-377
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Expert Review
Conflicts of interest:
None
Take Home Message:
Important from a public health perspective:
- To mitigate toxic agrochemical exposure;
- To provide evidence of the potential benefits of organic food consumption;
- To promote an organic plant-based diet.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Background: The author highlights that pesticide exposure may be associated with a range of diseases and the potential benefits of organic food consumption. Organic farming restricts the use of certain pesticides as per Regulation (EU) 2018/848; hence potentially minimising toxic exposure.
Objectives: This blinded two-week randomised controlled dietary intervention (nested in a five-week diet crossover study) aimed to establish:
- The impact of Western vs. Mediterranean diets, organic vs. non-organic food consumption and gender related to urinary pesticide residue excretion (UPRE);
- Associations between specific diet components and UPRE.
Study Design
Sample size: 27 males and females (n =27)
Intervention group:
- Sample size = 13 ( 5 males and 8 females);
- Consumed an organic-based Mediterranean diet.
Control group:
- Sample size = 14 (9 males and 5 females);
- Consumed a non-organic Mediterranean diet.
Both cohorts consumed a regular Western diet before and after the two-week trial.
Results:
- Total UPRE was 91% lower with organic compared to non-organic food consumption (mean 17 μg/d; 95% CI: 15, 19 vs. mean 180 μg/d; 95% CI: 153, 208) (for P < 0.0001));
- In the control group, replacing the traditional Western diet with a Mediterranean diet increased insecticide excretion from 7 to 25 μg/d, organophosphate excretion from 5 to 19 μg/d and pyrethroid residue excretion from 2.0 to 4.5 μg/d (all for P < 0.0001)
Conclusions: Replacing a traditional Western diet with a Mediterranean one was correlated to increased insecticide, organophosphate and pyrethroid exposure. However, organic food consumption attenuated exposure to the range of synthetic pesticides. Therefore, organic food consumption may result in reduced toxic pesticide exposure.
Clinical practice applications:
These findings might be useful for Nutritional Therapists and Clinical Practitioners:
- To inform clients of the potential pesticide exposure risk of non-organic compared to organic foods;
- To highlight the benefits of an organic plant-based diet;
- To educate clients regarding possible toxic exposure of agrochemicals.
Considerations for future research:
- More extensive studies are required with higher sample sizes to ascertain effects more representative of the general population since associations do not infer causality;
- Confounders need to be carefully considered for future research;
- The length of this trial was short; hence longitudinal studies to assess long-term effects of organic food consumption and potential toxic pesticide exposure are required.
Abstract
BACKGROUND Observational studies have linked pesticide exposure to various diseases, whereas organic food consumption has been associated with positive health outcomes. Organic farming standards prohibit the use of most pesticides, and organic food consumption may therefore reduce pesticide exposure. OBJECTIVES To determine the effects of diet (Western compared with Mediterranean) and food type (conventional compared with organic) and sex on urinary pesticide residue excretion (UPRE), as well as associations between specific diet components and UPRE. METHODS In this 2-wk, randomized dietary intervention trial, healthy adults were randomly allocated to an intervention (n = 13) or conventional (n = 14) group. Whereas participants in the intervention group consumed a Mediterranean diet (MedDiet) made entirely from organic foods, the conventional group consumed a MedDiet made entirely from conventional foods. Both groups consumed habitual Western diets made from conventional foods before and after the 2-wk intervention period. The primary outcome was UPRE. In addition, we assessed diet composition and pesticide residue profiles in foods eaten. Participants were aware of group assignment, but the study assessors were not. RESULTS During the intervention period, total UPRE was 91% lower with organic (mean 17 μg/d; 95% CI: 15, 19) than with conventional (mean 180 μg/d; 95% CI: 153, 208) food consumption (P < 0.0001). In the conventional group, switching from the habitual Western diet to the MedDiet increased insecticide excretion from 7 to 25 μg/d (P < 0.0001), organophosphate excretion from 5 to 19 μg/d (P < 0.0001), and pyrethroid residue excretion from 2.0 to 4.5 μg/d (P < 0.0001). Small but significant effects of sex were detected for chlormequat, herbicide, and total pesticide residue excretion. CONCLUSIONS Changing from a habitual Western diet to a MedDiet was associated with increased insecticide, organophosphate, and pyrethroid exposure, whereas organic food consumption reduced exposure to all groups of synthetic chemical pesticides. This may explain the positive health outcomes linked to organic food consumption in observational studies. This trial was registered at www.clinicaltrials.gov as NCT03254537.
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Effect of Tart Cherry on Aromatase Inhibitor-Induced Arthralgia (AIA) in Nonmetastatic Hormone-Positive Breast Cancer Patients: A Randomized Double-Blind Placebo-Controlled Trial.
Shenouda, M, Copley, R, Pacioles, T, Lebowicz, Y, Jamil, M, Akpanudo, S, Tirona, MT
Clinical breast cancer. 2022;22(1):e30-e36
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Aromatase inhibitors (AIs) are used as a treatment in breast cancer; however, a side effect of their use is often the development of aromatase inhibitor induced arthralgia (AIA), which manifests as pain in the joints, muscle weakness and reduced grip strength. Subsequently, many individuals stop taking AIs, resulting in poorer disease prognosis. Tart cherries (TC) have been shown in studies to help relieve joint pain and pain associated with exercise and so this RCT aimed to determine the effect of TC consumption on 60 breast cancer patients with AIA. The results showed that after 6-weeks individuals given TC had less pain, with some individuals reporting no pain at all. It was concluded that TC is a reliable and safe option for the management of AIA in breast cancer patients. This study could be used by healthcare professionals to recommend TC as an adjunct to aromatase inhibitor therapy in individuals with breast cancer who are experiencing pain.
Abstract
BACKGROUND Aromatase Inhibitor induced Arthralgia (AIA) can cause noncompliance leading to decreased breast-cancer survival. Effective interventions for AIA are limited. Tart cherry (TC) showed beneficial effect on musculoskeletal pain. 48 patients (Pts) randomized to TC versus placebo over 6 weeks, TC (23pts) had 34.7% mean pain decrease versus 1.4% in Placebo (25pts). TC can improve AIA in nonmetastatic breast-cancer patients. METHODS Randomized, placebo-controlled, double-blind trial. Eligible patients with NMHPBC on AI for at least 4 weeks were randomized to TC concentrate [50 tart cherries] vs. placebo (P) [syrup] in 1:1 model. Patients instructed to consume 1 Oz of concentrate in 8 Oz water daily for 6 weeks, and document their pain intensity at baseline, weekly and at study completion in a diary using Visual Analog Scale (VAS), with 0 mm indicating no pain, and 100 mm indicating highest pain. RESULTS Sixty patients were enrolled. Two patients did not complete the study due to diarrhea, and 10 patients were noncompliant. Forty-eight patients were included in the final analysis. TC group (23 pts) had 34.7% mean decrease in pain compared to 1.4% in P group (25 pts). This difference was statistically significant (Mann-Whitney U Test, P = .034). CONCLUSIONS Tart cherry can significantly improve AIA in nonmetastatic breast cancer patient.
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Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial.
Gutiérrez-Castrellón, P, Gandara-Martí, T, Abreu Y Abreu, AT, Nieto-Rufino, CD, López-Orduña, E, Jiménez-Escobar, I, Jiménez-Gutiérrez, C, López-Velazquez, G, Espadaler-Mazo, J
Gut microbes. 2022;14(1):2018899
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Expert Review
Conflicts of interest:
None
Take Home Message:
- It is advisable for those over 60 years old with a metabolic risk factor (BMI>30, diabetes and/or hypertension) to consult with their clinical practitioners if tested positive for Covid-19.
- Specific probiotic strains are reported to show positive results in reducing the duration and severity of Covid-19 symptoms in adults under 60 years old.
- These probiotics (Lactiplantibacillus plantarum KABP022, KABP023, and KAPB033, plus strain Pediococcus acidilactici KABP021) have also shown a positive effect on reducing inflammation and supporting remission of Covid-19.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
A quadruple-blinded, randomized trial was conducted in adults with symptomatic Coronavirus Disease 2019(Covid19) outpatients.
Three hundred subjects between the ages of 18 and 60 years, with a peripheral oxygen saturation (SpO2) ≥ 90% and in whom 42% had known metabolic risk factors for severe Covid19, were randomized to a oral probiotic containing Lactiplantibacillus plantarum KABP022, KABP023, and KAPB033, with Pediococcus acidilactici strain KABP021, totaling 2 x 109 colony-forming units (n=150), or placebo (n=150), for 30 days. At endpoint, 293/300 subjects finished the study.
Primary clinical outcomes were:
- Complete remission was achieved by 78 of 147 (53.1%) in probiotic group compared to 41 of 146 (28.1%) in placebo (P< .001).
- Adverse events were lower in the probiotic group (p=0.008), though not statistically significant in those taking ≥2 medications daily (risk ratio 0.66 (95%CI 0.29-1.48)
- No hospitalizations or deaths occurred during the study.
Secondary clinical outcomes were:
- The probiotic treatment was well-tolerated and reduce the duration of both digestive and non-digestive symptoms, compared to placebo.
- The probiotic treatment was associated with reduce nasopharyngeal viral load compared to placebo (P < .001) and reduce lung infiltrates (P < .001).
Furthermore, the probiotic treatment
- significantly increased specific IgM and IgG against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) and
- lower serum levels of high-sensitivity C-reactive protein (hsCRP) (P<00.1) and D-Dimer levels (P,00.1) compared to placebo.
- shortened median recovery time by 5 days (p<0.001).
Clinical practice applications:
- General practitioners, pharmacists, and clinic nurses are generally the first point of contact for patients who are not feeling well. Especially, during a pandemic when hospitals are inundated with patients who need urgent care. It is therefore essential for clinicians to have outpatient treatment protocols available to support the community.
- The microbiome is reported to be the first line of defense and interacts with the human host’s immune system. Therefore, probiotics may be useful as a preventative and supportive measure during a pandemic.
- Based on this study, practitioners could therefore consider a probiotic containing Lactiplantibacillus plantarum and Pediococcus acidilactici strains alone or in combination with other probiotic strains as a supportive measure.
Considerations for future research:
- Future studies are needed to replicate these findings and elucidate its mechanism of action, particularly as fecal microbiome analysis in a subset of n=100 subjects did not detect a difference in fecal microbiome composition between groups at baseline or endpoint.
- Additionally, further studies are needed to identify specific probiotic strains that display immune effects and their required dosage.
- Elevated D-Dimer levels are associated with a higher risk of thrombotic events such as pulmonary embolism and have been associated with Covid19 severity and mortality. Therefore, further investigation of this probiotic formula in helping prevent thrombotic complications in Covid19 is warranted.
- All the subjects in the study were of Hispanic ethnicity, therefore further studies of other ethnicities are required.
- This study was capped at 60-year-olds, thus studies in older subjects are warranted.
- Conflict of interest statement: This study was fully funded by the manufacturer of the provided probiotic, and authors received either speaker fees or institutional support from the manufacturer.
Abstract
Intestinal bacteria may influence lung homeostasis via the gut-lung axis. We conducted a single-center, quadruple-blinded, randomized trial in adult symptomatic Coronavirus Disease 2019 (Covid19) outpatients. Subjects were allocated 1:1 to probiotic formula (strains Lactiplantibacillus plantarum KABP022, KABP023, and KAPB033, plus strain Pediococcus acidilactici KABP021, totaling 2 × 109 colony-forming units (CFU)) or placebo, for 30 days. Co-primary endpoints included: i) proportion of patients in complete symptomatic and viral remission; ii) proportion progressing to moderate or severe disease with hospitalization, or death; and iii) days on Intensive Care Unit (ICU). Three hundred subjects were randomized (median age 37.0 years [range 18 to 60], 161 [53.7%] women, 126 [42.0%] having known metabolic risk factors), and 293 completed the study (97.7%). Complete remission was achieved by 78 of 147 (53.1%) in probiotic group compared to 41 of 146 (28.1%) in placebo (RR: 1.89 [95 CI 1.40-2.55]; P < .001), significant after multiplicity correction. No hospitalizations or deaths occurred during the study, precluding the assessment of remaining co-primary outcomes. Probiotic supplementation was well-tolerated and reduced nasopharyngeal viral load, lung infiltrates and duration of both digestive and non-digestive symptoms, compared to placebo. No significant compositional changes were detected in fecal microbiota between probiotic and placebo, but probiotic supplementation significantly increased specific IgM and IgG against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) compared to placebo. It is thus hypothesized this probiotic primarily acts by interacting with the host's immune system rather than changing colonic microbiota composition. Future studies should replicate these findings and elucidate its mechanism of action (Registration: NCT04517422).Abbreviations: AE: Adverse Event; BMI: Body Mass Index; CONSORT CONsolidated Standards of Reporting Trials; CFU: Colony-Forming Units; eDRF: Electronic Daily Report Form; GLA: Gut-Lung Axis; GSRS Gastrointestinal Symptoms Rating Scale; hsCRP: High-sensitivity C-Reactive Protein; HR: Hazard Ratio; ICU: Intensive Care Unit; OR: Odds Ratio; PCoA: Principal Coordinate Analysis; RR: Relative Risk; RT-qPCR: Real-Time Quantitative Polymerase Chain Reaction; SARS-CoV2: Severe acute respiratory syndrome coronavirus 2; SpO2: Peripheral Oxygen Saturation; WHO: World Health Organization.
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Effects of a gluten challenge in patients with irritable bowel syndrome: a randomized single-blind controlled clinical trial.
Saadati, S, Sadeghi, A, Mohaghegh-Shalmani, H, Rostami-Nejad, M, Elli, L, Asadzadeh-Aghdaei, H, Rodrigo, L, Zali, MR
Scientific reports. 2022;12(1):4960
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Expert Review
Conflicts of interest:
None
Take Home Message:
- The results of this study suggest that a strict gluten-free, low FODMAP diet could be used in Individuals with IBS for anxiety reduction and improvement in quality of life.
- However, only a small number of participants were included and followed for a short duration.
- IBS is a complex disorder the cause of which is largely unknown. It requires a multidisciplinary approach in its treatment.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Irritable bowel syndrome (IBS), a functional disorder of the lower gastrointestinal tract, is characterized by various somatic and psychological manifestations. Evidence suggests IBS and non-celiac gluten sensitivity (NCGS) overlap. The development of IBS is thought to be multifactorial. Low-grade inflammation and food intolerances including to gluten and fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP), may play a role. Gluten tolerance is a major dilemma in medical practice.
The aim of this randomized controlled trial is to evaluate tolerance to gluten, anxiety and quality of life in irritable bowel syndrome (IBS). Prevalence of non-celiac gluten sensitivity (NCGS) was also reported. This trial was conducted in Tehran, Iran, in adults aged 18-80 years and with symptoms of IBS according to the ROME-IV criteria.
In informing their research question, the authors reference evidence of the efficacy of a gluten-free diet (GFD) and a low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet on IBS symptoms.
One hundred and seven subjects were enrolled into phase I of the study, when a strict low-FODMAP and GFD was introduced for six weeks. Seventy subjects completed phase 1, of which twenty subjects declined to continue, leaving fifty subjects. These fifty subjects were enrolled into phase 2 and randomized into three groups (i) an unrestricted gluten diet (n=10), (ii) continuation of the low-FODMAP/GFD (n=15), and (iii) a gluten challenge group (n=25), for a further six weeks.
Reductions in bloating (3.5±2.6 to 2.5±2.1, p=0.03) and pain severity (2.9±2.8 to 2±2.2, p=0.02) were observed in the GFD, and a reduction in total VAS score (45.6±15.9 to 27.8±12.8, p=0.05) in the high-gluten group. The satiety score increased (2.3±1 to 3.8±3.1, p=0.04) in the unrestricted gluten diet group. At the end of the study, differences for pain frequency, pain severity and impact on community function were observed between the groups.
In this study, a low-FODMAP strict GFD was shown to reduce anxiety and improve the quality of life.
Clinical practice applications:
- In the gluten challenge phase of the study, between-group analysis revealed significant differences for pain and impact on community function No significant differences were found for bloating, satiety, defecation, total score, anxiety scores or quality of life between the groups. These mixed results, also found in other studies, add weight to the fact that the cause of IBS is unclear. The authors hypothesize that there may be an IBS subtype or new medical term, categorized as gluten sensitivity-IBS.
- Symptoms were evaluated but not objective outcomes, for example blood biomarkers. No aggravation of symptoms was observed in this study following the gluten challenge. Other non-gluten components of food may be responsible for IBS symptoms. Recent evidence suggests that fructans may be responsible in individuals with IBS and a low-FODMAP diet may be beneficial.
- Biopsychological factors are important to consider in the duration and severity of IBS symptoms.
- A strict GFD can come with problems, as mentioned, nutritional deficiencies, difficulty finding GF foods, high cost, altered taste, impacts on social/quality of life.
- Results were mixed, however suggest a low-FODMAP strict GFD could be a therapeutic choice for the management of IBS particularly in reducing anxiety and improving quality of life.
Considerations for future research:
- Randomized controlled trials with greater numbers of participants and longer durations assessing the impact of a low-FODMAP strict GFD in IBS, are warranted.
- Including food sensitivity/intolerance testing may be useful to distinguish which individuals might benefit from a GFD alone, a low-FODMAP diet alone or a low-FODMAP GFD.
- Small intestinal bacterial overgrowth (SIBO) testing would be of interest to understand who might benefit from a low-FODMAP diet.
- Studies assessing baseline stress levels and stress management interventions in combination with dietary interventions such as low-FODMAP GFD could be important avenues of research.
Abstract
Non-celiac gluten sensitivity (NCGS) and irritable bowel syndrome (IBS) frequently overlap. Although, gluten-free diet (GFD) and low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) improve the IBS clinical picture, many aspects remain unclear. Therefore, we designed a study to evaluate gluten tolerance, anxiety and quality of life in a specific study population. Fifty IBS patients were asked to follow a low FODMAP strict GFD for 6 weeks and were then randomly allocated to the following groups for a further 6 weeks: (A) receiving 8 g/day of gluten for 2 weeks; gluten-tolerating subjects received 16 g/day for 2 weeks and then 32 g/day for a further 2 weeks; (B) continuing to follow a low FODMAP strict GFD; and (C) receiving a gluten-containing diet. After the first 6 weeks, symptom scores significantly improved. Pain severity, bloating and total score were significantly decreased in the GFD and in the high-gluten groups, while the satiety score significantly increased in group C. Between-group analysis revealed significant differences for pain severity (p = 0.02), pain frequency (p = 0.04) and impact on community function (p = 0.02) at the end of the study. Our findings suggest that low FODMAP strict GFD could be prescribed in IBS patients and would reduce anxiety and improve the quality of life.
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10.
Effect of soy isoflavones supplementation on migraine characteristics, mental status and calcitonin gene-related peptide (CGRP) levels in women with migraine: results of randomised controlled trial.
Babapour, M, Khorvash, F, Rouhani, MH, Ghavami, A, Ghasemi-Tehrani, H, Heidari, Z, Karbasi, M, Moradi, F, Askari, G
Nutrition journal. 2022;21(1):50
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Plain language summary
Migraine is considered as an intense unilateral throbbing headache, often accompanied by nausea, vomiting, photophobia and phonophobia, which can be exacerbated by routine physical activity. It has been shown that cytokines levels are altered in migraineurs. Cytokines are inflammatory mediators that can stimulate calcitonin gene-related peptide (CGRP) [amino acid] transcription. The aim of this study was to investigate the effects of soy isoflavones supplementation on migraine headache characteristics, mental status, quality of life and CGRP concentration in adult women with migraine. This study is a double-blind, placebo-controlled clinic trial. Participants (n=88 women) were randomly assigned to one of the two groups: intervention or placebo groups (1:1). Patients in the intervention group received one tablet containing 50 mg isoflavones. Results indicate that consumption of 50 mg/day soy isoflavones supplementation for 8 weeks led to significant reduction in frequency, duration, and clinical indices of migraine and improved quality of life and CGRP levels. However, severity of migraine headache and mental status including depression, stress and anxiety were not affected by supplementation. Authors conclude that even though their findings were promising, further studies focusing on the mental status dimensions including depression, stress and anxiety are needed.
Abstract
BACKGROUND Literature suggests a relationship between estrogen levels and migraine headache pathogenesis. However, the effect of soy isoflavones on migraine characteristic remains unclear. This study aimed to investigate the effect of soy isoflavones on migraine characteristics and calcitonin gene-related peptide (CGRP) levels in women with migraine. METHODS Eighty-three participants completed a randomized double-blind controlled trial, receiving 50 mg per day soy isoflavones or placebo supplementation for 8 weeks. Migraine severity, migraine days per month, frequency and duration of attacks, mental status, quality of life and serum CGRP levels were measured at baseline and the end of the intervention. Bivariate comparison and intention-to-treat (ITT) were used for analysis. RESULTS Soy isoflavones intake resulted in a significant decrease in mean frequency (-2.36 vs -0.43, P < 0.001), duration (-2.50 vs -0.02, P < 0.001) of migraine attacks and CGRP level (-12.18 ng/l vs -8.62, P = 0.002) in compared to placebo group. Also, a significant improvement was found in quality of life (16.76 vs 2.52, P < 0.001). Although, reduction in the migraine severity and mental status did not reach a statistically significant level (P > 0.05). CONCLUSION soy isoflavones supplementation may be considered as a complementary treatment for women with migraine to improve migraine characteristics and reduce the burden of disease.