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The effects of time-restricted eating and weight loss on bone metabolism and health: a 6-month randomized controlled trial.
Papageorgiou, M, Biver, E, Mareschal, J, Phillips, NE, Hemmer, A, Biolley, E, Schwab, N, Manoogian, ENC, Gonzalez Rodriguez, E, Aeberli, D, et al
Obesity (Silver Spring, Md.). 2023;31 Suppl 1:85-95
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Intermittent fasting (IF) involves an alternation of abstinence and consumption of food and caloric beverages over a cycle of hours to days. Time-restricted feeding (in animals) or eating (TRE in humans) is a form of IF that entails restricting eating within a window of 4 to 12 hours per 24-hour cycle and prolonging the time spent in the fasted state to realign eating-fasting patterns with circadian rhythms. The aim of this study was to explore the impact of a 6-month randomised controlled trial of TRE versus standard dietary advice (SDA, active control arm) on bone metabolism and health in a population with at least one component of the metabolic syndrome. This study is a secondary analysis of an open-label 6-month randomised controlled trial in which participants who ate within a time interval > 14 hours per 24-hour cycle (n=54) were randomised to TRE or SDA (active control) with a 1:1 allocation ratio. A total of 42 participants (76% women) with available bone turnover markers and/or bone mass measurements were included in this study. Results show that there weren’t any detrimental effects on bone health outcomes i.e. bone metabolism or bone loss after 6 months of TRE. Additionally, weight loss following a period of TRE might be associated with small bone-sparing effects compared with SDA. Authors conclude that future studies of longer duration (>6 months) assessing multiple bone phenotypes are required in order to confirm the study’s findings and explore the effects of various TRE regimens particularly among individuals at risk for bone fragility such as postmenopausal women and the elderly.
Abstract
OBJECTIVE This study explored the impact of time-restricted eating (TRE) versus standard dietary advice (SDA) on bone health. METHODS Adults with ≥1 component of metabolic syndrome were randomized to TRE (ad libitum eating within 12 hours) or SDA (food pyramid brochure). Bone turnover markers and bone mineral content/density by dual energy x-ray absorptiometry were assessed at baseline and 6-month follow-up. Statistical analyses were performed in the total population and by weight loss response. RESULTS In the total population (n = 42, 76% women, median age 47 years [IQR: 31-52]), there were no between-group differences (TRE vs. SDA) in any bone parameter. Among weight loss responders (≥0.6 kg weight loss), the bone resorption marker β-carboxyterminal telopeptide of type I collagen tended to decrease after TRE but increase after SDA (between-group differences p = 0.041), whereas changes in the bone formation marker procollagen type I N-propeptide did not differ between groups. Total body bone mineral content decreased after SDA (p = 0.028) but remained unchanged after TRE (p = 0.31) in weight loss responders (between-group differences p = 0.028). Among nonresponders (<0.6 kg weight loss), there were no between-group differences in bone outcomes. CONCLUSIONS TRE had no detrimental impact on bone health, whereas, when weight loss occurred, it was associated with some bone-sparing effects compared with SDA.
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Effect of a Probiotic and a Synbiotic on Body Fat Mass, Body Weight and Traits of Metabolic Syndrome in Individuals with Abdominal Overweight: A Human, Double-Blind, Randomised, Controlled Clinical Study.
Laue, C, Papazova, E, Pannenbeckers, A, Schrezenmeir, J
Nutrients. 2023;15(13)
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Numerous studies have provided evidence that the intestinal microbiota has a key role in the interface between dietary factors and host biology and that overweight, diabetes and liver steatosis, which are known to depend on dietary factors, are associated with alterations in the composition and diversity of the intestinal microbiota. The aim of this study was to investigate the effect of a probiotic and synbiotic strains on traits of metabolic syndrome, which is driven by low-grade inflammation. This study was a double-blind, randomised, placebo-controlled design with three parallel arms. A total of 180 female and male overweight individuals aged ≥18 years were enrolled. Results showed that: - the probiotic resulted in significant improvements in the primary parameter, body fat mass; body weight; body mass index; waist circumference; waist-to-height ratio; visceral adipose tissue and in liver steatosis grade, as assessed with sonography. - the synbiotic resulted in better outcomes in visceral adipose tissue and liver steatosis grade, as assessed with sonography, and in reduction in constipation. - the count of viable lactobacilli was lower in the synbiotic test product than in the probiotic test product Authors concluded that the probiotic mixture and the synbiotic improved the parameters associated with overweight.
Abstract
L. fermentum strains K7-Lb1, K8-Lb1 and K11-Lb3 were found to suppress Th1 and Th2 response and to enhance defensin release by enterocytes, respectively. Based on these anti-inflammatory actions, we investigated the effect of these strains on traits of metabolic syndrome, which is driven by low-grade inflammation. In a double-blind, randomised, placebo-controlled clinical trial with three parallel arms, 180 individuals with abdominal overweight were administered for 3 months with (1) placebo; (2) probiotic, comprising L. fermentum strains; or (3) synbiotic, comprising the strains + acacia gum (10 g daily). The effects were evaluated using Kruskal-Wallis one-way analysis of variance on ranks and post hoc tests (Holm-Sidak and Dunn's tests). The alteration (∆) in body fat mass (kg) (primary parameter) during intervention was significantly (p = 0.039) more pronounced in the Probiotic group (-0.61 ± 1.94; mean ± SD) compared with the Placebo group (+0.13 ± 1.64). Accordingly, differences were found in ∆ body weight (p = 0.012), BMI (p = 0.011), waist circumference (p = 0.03), waist-to-height ratio (p = 0.033), visceral adipose tissue (SAD) (p < 0.001) and liver steatosis grade (LSG) (p < 0.001), as assessed using sonography. In the Synbiotic group, ∆SAD (p = 0.002), ∆LSG (p < 0.001) and ∆constipation score (p = 0.009) were improved compared with Placebo. The probiotic mixture and the synbiotic improved the parameters associated with overweight.
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Testosterone does not affect lower urinary tract symptoms while improving markers of prostatitis in men with benign prostatic hyperplasia: a randomized clinical trial.
Rastrelli, G, Cipriani, S, Lotti, F, Cellai, I, Comeglio, P, Filippi, S, Boddi, V, Della Camera, PA, Santi, R, Boni, L, et al
Journal of endocrinological investigation. 2022;45(7):1413-1425
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Benign prostatic hyperplasia (BPH) — also called benign prostate enlargement — is frequent in aging populations, with a 40 – 50% prevalence in men aged 50–60 years and up to 90% in men older than 80 years. The aim of this study was to verify whether testosterone therapy (TTh) in men with BPH, metabolic syndrome (MetS) and low testosterone is able to improve lower urinary tract symptoms (LUTS) and intraprostatic inflammation. This study is a double blind, randomised 24-week clinical trial in men with low testosterone and MetS and a candidate for prostate surgery for BPH. Patients (n=144) were centrally randomised 1:1 to one of the two groups; TTh or placebo. Results show that TTh administered for 24 weeks is a safe option and it improves prostatic inflammatory features thus ameliorating one of the pathogenic components of BPH. However, there were no differences in improvements of the urinary symptoms between both groups (TTh and placebo). Authors conclude that decreased inflammation is not accompanied by a consistent improvement in urinary symptoms, and that their findings show the safety of TTh in subjects with BPH of surgical significance.
Abstract
PURPOSE Benign Prostatic Hyperplasia (BPH) is a result of prostate inflammation, frequently occurring in metabolic syndrome (MetS). Low testosterone is common in MetS. A randomized clinical trial was designed to evaluate if 24 weeks of testosterone therapy (TTh) in BPH men with MetS and low testosterone improve urinary symptoms and prostate inflammation. METHODS One-hundred-twenty men with MetS waitlisted for BPH surgery were enrolled. They were categorized into normal testosterone (TT ≥ 12 nmol/L and cFT ≥ 225 pmol/L; n = 48) and testosterone deficient (TD) (TT < 12 nmol/L and/or cFT < 225 pmol/L; n = 72) then randomized to testosterone gel 2% (5 g/daily) or placebo for 24 weeks. At baseline and follow-up, questionnaires for urinary symptoms and trans-rectal ultrasound were performed. Prostate tissue was collected for molecular and histopathological analyses. RESULTS No differences in the improvement of urinary symptoms were found between TTh and placebo (OR [95% CI] 0.96 [0.39; 2.37]). In TD + TTh, increase in prostate but not adenoma volume was observed (2.64 mL [0.07; 5.20] and 1.82 mL [- 0.46; 0.41], respectively). Ultrasound markers of inflammation were improved. In a subset of 61 men, a hyper-expression of several pro-inflammatory genes was found in TD + placebo when compared with normal testosterone. TTh was able to counteract this effect. For 80 men, the inflammatory infiltrate was higher in TD + placebo than in normal testosterone (0.8 points [0.2; 1.4]) and TD + TTh men (0.9 points [0.2; 1.5]). CONCLUSIONS Twenty-four weeks of TTh in TD men with BPH and MetS improves ultrasound, molecular and histological proxies of prostate inflammation. This does not result in symptom improvement.
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Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial.
Roager, HM, Vogt, JK, Kristensen, M, Hansen, LBS, Ibrügger, S, Mærkedahl, RB, Bahl, MI, Lind, MV, Nielsen, RL, Frøkiær, H, et al
Gut. 2019;68(1):83-93
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Whole grain consumption has been linked with decreased risk of lifestyle-related diseases. While animal studies have shown the gut microbiome to be a mediator of metabolic health, human studies examining the effect of whole grain intake of the gut remain inconclusive. The aim of this study was to investigate the effects of a whole grain diet on the gut microbiome, gut functionality and biomarkers of metabolic health. In this randomised, controlled, crossover study, 50 participants completed two 8-week dietary intervention periods comprising of a whole grain diet and a refined grain diet with a 6-week washout period. Examinations were done at the beginning and end of each intervention period to assess anthropometry and various plasma and gut markers. This study found that a whole grain diet as compared with a refined grain diet reduced energy intake and body weight as well as circulating markers of inflammation. Contrary to the hypothesis, these benefits were all observed independent of changes in the gut microbiome. Based on these results, the authors conclude higher intake of whole grains should be recommended to those at risk of inflammation-related disease.
Abstract
OBJECTIVE To investigate whether a whole grain diet alters the gut microbiome and insulin sensitivity, as well as biomarkers of metabolic health and gut functionality. DESIGN 60 Danish adults at risk of developing metabolic syndrome were included in a randomised cross-over trial with two 8-week dietary intervention periods comprising whole grain diet and refined grain diet, separated by a washout period of ≥6 weeks. The response to the interventions on the gut microbiome composition and insulin sensitivity as well on measures of glucose and lipid metabolism, gut functionality, inflammatory markers, anthropometry and urine metabolomics were assessed. RESULTS 50 participants completed both periods with a whole grain intake of 179±50 g/day and 13±10 g/day in the whole grain and refined grain period, respectively. Compliance was confirmed by a difference in plasma alkylresorcinols (p<0.0001). Compared with refined grain, whole grain did not significantly alter glucose homeostasis and did not induce major changes in the faecal microbiome. Also, breath hydrogen levels, plasma short-chain fatty acids, intestinal integrity and intestinal transit time were not affected. The whole grain diet did, however, compared with the refined grain diet, decrease body weight (p<0.0001), serum inflammatory markers, interleukin (IL)-6 (p=0.009) and C-reactive protein (p=0.003). The reduction in body weight was consistent with a reduction in energy intake, and IL-6 reduction was associated with the amount of whole grain consumed, in particular with intake of rye. CONCLUSION Compared with refined grain diet, whole grain diet did not alter insulin sensitivity and gut microbiome but reduced body weight and systemic low-grade inflammation. TRIAL REGISTRATION NUMBER NCT01731366; Results.
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Effect of Fish Oil Supplementation on Hepatic and Visceral Fat in Overweight Men: A Randomized Controlled Trial.
Parker, HM, Cohn, JS, O'Connor, HT, Garg, ML, Caterson, ID, George, J, Johnson, NA
Nutrients. 2019;11(2)
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Being overweight increases the risk of the development of metabolic conditions such as non-alcoholic fatty liver disease (NAFLD). Omega-3 polyunsaturated fatty acid (PUFA) supplementation is recommended for prevention of chronic disease, and is thought to reduce liver fat, but there have been few randomised controlled trials that accurately measure liver fat. The aim of this double-blind randomised controlled trial was to assess the effect of 12 weeks of supplementation with omega-3 PUFA from fish oil on liver fat, liver tests, and body composition. Fifty healthy overweight men were given either fish oil (1,728 mg marine triglycerides, of which 588 mg EPA and 412 mg DHA, combined with 200 mg antioxidant, coenzyme Q10) or placebo (capsules containing 2g olive oil) daily for 12 weeks. Participants were assessed at the beginning of the study, and following 6 and 12 weeks of supplementation. At the start of the study, 16 (32%) participants met the criteria for NAFLD (>5.5% liver fat). There were no significant changes in liver fat, liver function or body composition in either of the groups over 12 weeks. When the researchers looked at the results for those participants with NAFLD at the start of the study, there were no significant changes here either. The authors concluded that omega-3 PUFA did not appear to be an effective agent for reducing liver fat in overweight men. The factors determining the health benefits of omega-3 PUFA supplementation on an individual level need to be clarified.
Abstract
Being overweight increases the risk of the development of metabolic conditions such as non-alcoholic fatty liver disease (NAFLD), which is itself an independent predictor of cardiovascular disease. Omega-3 polyunsaturated fatty acid (PUFA) supplementation is recommended for prevention of chronic disease, and is thought to reduce raised liver fat, yet there have been few randomized controlled trials with accurate measurement of liver fat. We assessed the effect of 12 weeks of supplementation with omega-3 PUFA from fish oil versus placebo on quantified liver fat, liver tests, and body composition including visceral adipose tissue (VAT) in a double-blind randomized controlled trial. Fifty apparently healthy overweight men (BMI 25.0⁻29.9 kg/m²; waist > 94 cm) were randomly allocated to consume fish oil (total daily dose: 1728 mg marine triglycerides, of which 588 mg EPA and 412 mg DHA, combined with 200 mg antioxidant, coenzyme Q10) or placebo (olive oil capsules) daily for 12 weeks. Liver fat was assessed using proton magnetic resonance spectroscopy. All outcomes were assessed at baseline and following 6 and 12 weeks of supplementation. Baseline liver fat was 4.6 ± 0.5% (range: 0.6 to 18.2%); 16 (32%) participants met the criteria for NAFLD (>5.5% liver fat). Repeated measures ANOVA revealed no significant time or group × time effect for fish oil versus placebo for liver fat, liver enzymes, anthropometry, or body composition including VAT (p > 0.05 for all), with similar finding for sub-analysis of participants with NAFLD. Omega-3 PUFA did not appear to be an effective agent for reducing liver fat in overweight men. The factors determining the health benefits of omega-3 PUFA supplementation on an individual level need to be clarified.
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Effect of intermittent vs. daily calorie restriction on changes in weight and patient-reported outcomes in people with multiple sclerosis.
Fitzgerald, KC, Vizthum, D, Henry-Barron, B, Schweitzer, A, Cassard, SD, Kossoff, E, Hartman, AL, Kapogiannis, D, Sullivan, P, Baer, DJ, et al
Multiple sclerosis and related disorders. 2018;23:33-39
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Multiple sclerosis (MS) is a disease of the central nervous system. Dietary modification is emerging as a safe intervention to potentially modify disease course. The main aim of this study was to assess the safety and feasibility of an intermittent fasting diet in people with MS. Secondary outcomes explored the effects of calorie restriction (CR) diets on body weight and anthropometric characteristics as well as on patient-reported outcomes including fatigue, sleep and mood. The study is a pilot randomised controlled feeding study of three different types of diets. Each participant (n=36) was randomized to 1 of 3 diets: a control diet (placebo), a daily CR diet and intermittent CR diet. Results indicate that daily CR diet was associated with marginally greater weight loss than the intermittent CR diet. Both CR diets were associated with trends toward improvements in cardiometabolic outcomes. Furthermore, CR diets were associated with in improvements in emotional well-being. Authors conclude that CR and weight loss represent interventions for clinically relevant symptoms due to MS, such as emotional well-being, without adding meaningful risks or adverse outcomes.
Abstract
An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4 kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6 kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0 kg [IQR: -1.95, -4.1]; P = 0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P = 0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health.
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Association of dietary patterns, anthropometric measurements, and metabolic parameters with C-reactive protein and neutrophil-to-lymphocyte ratio in middle-aged and older adults with metabolic syndrome in Taiwan: a cross-sectional study.
Syauqy, A, Hsu, CY, Rau, HH, Chao, JC
Nutrition journal. 2018;17(1):106
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Metabolic syndrome, which is classified as having high blood pressure, obesity, high blood glucose and high cholesterol, is believed to be a consequence of the Westernised diet and lifestyle, which has become increasingly common place in several countries worldwide. The Westernised diet comprises of a high intake of saturated fats, meats, processed foods, sweets, salt and food additives, all of which can add to the burden of inflammatory processes. The objective of this cross-sectional study was to investigate associations evident between diet, body composition and metabolic measurements (such as BMI and blood pressure) with inflammatory markers; C-reactive protein and neutrophil-to-lymphocyte ratio (inflammatory markers that increase in response to inflammation), in adults diagnosed with metabolic syndrome. Researchers found that regardless of gender or age, there was a direct association with C-reactive protein and neutrophil-to-lymphocyte ratio and metabolic syndrome. The subjects who consumed a higher amount of ‘Westernised foods’ showed higher levels of inflammatory markers when compared to those who a consumed a more healthful diet.
Abstract
BACKGROUND Metabolic syndrome is commonly associated with inflammation. The underlying factors of inflammation in metabolic syndrome are not fully understood. The objective of the study was to determine the association of dietary patterns, anthropometric measurements, and metabolic parameters with inflammatory markers in middle-aged and older adults with metabolic syndrome in Taiwan. METHODS A total of 26,016 subjects aged ≥35 y with metabolic syndrome were recruited from Mei Jau institution between 2004 and 2013 for a cross sectional study. Metabolic syndrome was defined by the International Diabetes Federation. Multivariate logistic regression was performed to evaluate the association of dietary patterns, anthropometric measurements, and metabolic parameters with C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio (NLR) in men and women with metabolic syndrome. Crude and adjusted models were analyzed by gender. RESULTS The western dietary pattern, obesity, high body fat, high waist or hip circumference, and high waist-to-hip ratio were significantly associated with increased odds ratios of high CRP and NLR in both genders. High systolic or diastolic blood pressure (BP), low high-density lipoprotein-cholesterol (HDL-C), high low-density lipoprotein-cholesterol (LDL-C), high total cholesterol (TC), high serum triglycerides (TG), and high fasting blood glucose (FBG) were significantly correlated with increased odds ratios of high CRP in both genders. Low HDL-C, high LDL-C, high serum TG, and high FBG were significantly associated with increased odds ratios of high NLR in both genders. However, high systolic (OR = 1.124, 95% CI 1.047-1.206, P < 0.01) or diastolic BP (OR = 1.176, 95% CI 1.087-1.273, P < 0.001) and high TC (OR = 1.138, 95% CI 1.062-1.220, P < 0.001) were significantly correlated with increased odds ratios of high NLR only in men. CONCLUSIONS The western dietary pattern, obese-related anthropometric parameters, and most components of metabolic syndrome are positively associated with CRP levels and NLR in men and women with metabolic syndrome.