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Safety and efficacy of alpha-lipoic acid oral supplementation in the reduction of pain with unknown etiology: A monocentric, randomized, double-blind, placebo-controlled clinical trial.
Esposito, C, Ugo Garzarella, E, Santarcangelo, C, Di Minno, A, Dacrema, M, Sacchi, R, Piccinocchi, G, Piccinocchi, R, Daglia, M
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;144:112308
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The management of pain with no apparent cause, or idiopathic pain, is a real challenge. In the absence of any underlying disease that is treatable, idiopathic pain is usually addressed by relieving symptomatic pain with medication. Whereby these medications can be fast and effective, they can have limited benefits and, in some cases, considerable side effects. Alpha-lipoic acid (ALA) is a food supplement and naturally occurring compound in humans, animals and plants. Previous research suggested that it is effective in managing diabetic nerve pain. As reactive oxygen species and antioxidants appear to play a role in pain regulation, the antioxidant and anti-inflammatory activities of ALA are of interest here. In addition, ALA has a strong safety record. This study sought to investigate the safety and effectiveness of ALA in non-diabetic individuals who were diagnosed with idiopathic pain. 210 male and female subjects, from age 18-75, who were non-diabetic and on no pain medication were randomly assigned to receive either a placebo or 400 mg/day or 800 mg/day of ALA over a course of two months. The pain was tracked with two pain scoring questionnaires, whilst blood samples were monitored for adverse effects, including blood sugar, kidney and liver markers. The ALA intervention group showed a significant reduction in both pain scores compared to placebo. Treated subjects showed a marginal decrease in blood sugars of no clinical significance and no other adverse effects were reported. The authors concluded that ALA as a food supplement has suitable potential for the management of idiopathic pain. And given its safety and efficacy compared to commonly used pain medication it could be of interest in clinical application.
Abstract
INTRODUCTION Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and efficacy in the reduction of different forms of idiopathic pain. METHODS Two-hundred and ten normoglycemic adults suffering from idiopathic pain (i.e. 57 subjects with primitive neuropathic pain, 141 subjects with arthralgia with unknown etiology, and 12 subjects with idiopathic myalgia) were randomized to receive placebo, 400 mg/day, or 800 mg/day of ALA. Participants underwent two visits (at baseline = t0, and after 2 months = t1) in which two validated questionaries for pain (numerical rating scale [NRS] and visual analogue scale [VAS]) were collected; fasting blood glucose assessment, adverse effects, and renal and hepatic toxicity were also monitored. RESULTS At t1, none of subjects treated with ALA reported a decreased glycemia or adverse effects. The treated subjects showed a significant reduction in NRS (p < 0.001) while the placebo group did not show any NRS reduction (p = 0.86). Similar results were also obtained for VAS. Statistical analysis aimed at detecting possible differences in NRS and VAS scores among treatment groups based on the source of pain did not reveal any significant effect. CONCLUSIONS Since the management of idiopathic pain is challenging for physicians, the use of ALA food supplements could be a feasible option, based on its safety and efficacy compared to commonly-used analgesic drugs.
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Effects of Low-Carbohydrate versus Mediterranean Diets on Weight Loss, Glucose Metabolism, Insulin Kinetics and β-Cell Function in Morbidly Obese Individuals.
Tricò, D, Moriconi, D, Berta, R, Baldi, S, Quinones-Galvan, A, Guiducci, L, Taddei, S, Mari, A, Nannipieri, M
Nutrients. 2021;13(4)
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Both low-carbohydrate and Mediterranean style diets are used to prevent lifestyle associated diseases such as obesity and type 2 diabetes. However, which diet is more effective is unclear. The aim of this randomised control trial of 36 morbidly obese individuals was to compare the effectiveness of Mediterranean diets and low-carbohydrate diets to improve metabolic measures such as blood sugar levels, pre-diabetes, and the body’s ability to use sugar. The results showed that in the short-term both diets were equally effective at improving biochemical dysfunctions that contribute to type 2 diabetes. The low-carbohydrate diet did result in higher weight loss than the Mediterranean diet. Studies on long-term effects are warranted. It was concluded that a low-carbohydrate diet is in the short-term a feasible alternative to the Mediterranean diet for improved weight loss and biological contributors to type 2 diabetes. This study could be used by healthcare professionals to understand that the Mediterranean diet and low-carbohydrate diet are both effective in the short-term for improvements to contributors to type 2 diabetes, however the low-carbohydrate diet may be superior if weight loss is required.
Abstract
Low-calorie Mediterranean-style or low-carbohydrate dietary regimens are widely used nutritional strategies against obesity and associated metabolic diseases, including type 2 diabetes. The aim of this study was to compare the effectiveness of a balanced Mediterranean diet with a low-carbohydrate diet on weight loss and glucose homeostasis in morbidly obese individuals at high risk to develop diabetes. Insulin secretion, insulin clearance, and different β-cell function components were estimated by modeling plasma glucose, insulin and C-peptide profiles during 75-g oral glucose tolerance tests (OGTTs) performed at baseline and after 4 weeks of each dietary intervention. The average weight loss was 5%, being 58% greater in the low-carbohydrate-group than Mediterranean-group. Fasting plasma glucose and glucose tolerance were not affected by the diets. The two dietary regimens proved similarly effective in improving insulin resistance and fasting hyperinsulinemia, while enhancing endogenous insulin clearance and β-cell glucose sensitivity. In summary, we demonstrated that a low-carbohydrate diet is a successful short-term approach for weight loss in morbidly obese patients and a feasible alternative to the Mediterranean diet for its glucometabolic benefits, including improvements in insulin resistance, insulin clearance and β-cell function. Further studies are needed to compare the long-term efficacy and safety of the two diets.
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Type 2 diabetes preventive effects with a 12-months sardine-enriched diet in elderly population with prediabetes: An interventional, randomized and controlled trial.
Díaz-Rizzolo, DA, Serra, A, Colungo, C, Sala-Vila, A, Sisó-Almirall, A, Gomis, R
Clinical nutrition (Edinburgh, Scotland). 2021;40(5):2587-2598
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Older people have a higher risk of developing Type 2 diabetes (T2D) due to the possibility of β-cell dysfunction due to ageing. Sardines are believed to be protective against the development of T2D. Therefore, this randomised controlled trial evaluated the preventative effects of a sardine-rich diet in elderly prediabetic patients. For one year, both the sardine group (SG) and control group (CG) followed a T2D prevention diet, with the SG consuming 200 g of sardines each week. Both groups improved body weight, BMI, waist and hip circumference, and body composition. Taurine, EPA, DHA, omega-3 fatty acid, calcium, iodine, zinc, phosphorous and fluoride, vitamin B12 and D, and lycopene and tocopherols were found to be higher in the SG than the CG, indicating the sardines were protective against T2D. In SG, HDL cholesterol and adiponectin levels were significantly increased, and blood pressure and triglycerides were decreased, signalling a reduced risk of T2D and cardiovascular disease. In addition, SG showed a reduction in HOMA-IR and an Omega-3 fatty acid was substituted for Omega-6 fatty acids in the erythrocyte membrane, suggesting a reduced risk of T2D. Further robust research is required to confirm the protective effect of a sardine-enriched diet against T2D. It may be useful to healthcare providers to comprehend how a sardine-enriched diet could improve obesity, T2D and CVD markers in pre-diabetic elderly patients.
Abstract
BACKGROUND Fish could play a role in preventing type 2 diabetes (T2D) but there has been little specification about the type of fish and the preventive mechanism involved in its health claim. The sardine is a source of omega-3 and taurine that, in isolation or in synergy, would produce T2D-delaying through different molecular mechanism. HYPOTHESIS The consumption of twice a week of sardine, during one year would reduce T2D-developing risk in a population with prediabetes (preDM) and old age. DESIGN 152 subjects with fasting glucose between 100-124 mg/dL aged ≥65 yo were recruited from three primary care centers in Barcelona and were randomly distributed among two interventional groups: control group (CG) and sardine group (SG). Both groups received same T2D-prevention nutritional during a year but only SG had to add 200 g of sardine per week. All variables were collected before to start and at the end of the diet. (ClinicalTrials.gov: NCT03557541). RESULTS 152 people were randomized into CG (n=77) and SG (n=75) with 18 and 12 drop outs respectively. Subjects in SG, significantly compared to CG, decreased percentage classified-individuals in a very high risk group to develop T2D according to FINDRISC (p=0.035). In addition to increasing HDL-cholesterol and adiponectin and decreasing triglycerides (p<0.05) and blood pressure (<0.05), SG showed a lower HOMA-IR (p=0.032). The consumption of sardine characteristics nutrients as omega-3, EPA and DHA, vitamin D, fluorine and taurine were higher for SG (p<0.05). These results agreed with the increased of taurine, fatty acid (FA) omega-3 and bile acids circulating metabolites (p<0.05). Changes erythrocyte membrane FA were detected only in SG with a decrease of 5 omega-6 FA (p<0.001) and an increase of 3 omega-3 FA types (p<0.001). CONCLUSION We conclude that a year T2D-prevention diet with sardine supplementation has a greater protective effect against developing T2D and CV events.
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Effectiveness of Health Coaching in Diabetes Control and Lifestyle Improvement: A Randomized-Controlled Trial.
Lin, CL, Huang, LC, Chang, YT, Chen, RY, Yang, SH
Nutrients. 2021;13(11)
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World Health Organization statistics indicate that over 400 million people worldwide have Type 2 Diabetes. Health coaching is an approach to diabetes management that empowers patients to make healthier choices by changing their behaviours. This two-arm randomised controlled trial evaluated the effectiveness of health coaching in reducing blood sugar levels and following a healthy diet among Type 2 diabetic patients. Patients with diabetes improved their HbA1c by 0.62% after six months of health coaching. Through health coaching, patients were also able to reduce their calorie intake significantly by reducing their consumption of whole grains, meat, proteins, fats and oils and increasing their intake of vegetables. In the intervention group, diet modifications were also associated with a decrease in HbA1c. The benefits of health coaching in Type 2 diabetes management needs to be confirmed in more robust studies. However, healthcare professionals can use the results of this study to understand how behaviour change in diabetic patients contributes to blood sugar management and healthy eating.
Abstract
BACKGROUND The study aimed to look into the effectiveness of a 6-month health coaching intervention for HbA1c and healthy diet in the treatment of patients with type 2 diabetes. METHODS The study was carried out via a two-armed, randomized controlled trial that included 114 diabetic patients at a medical center in Taiwan. During the 6-month period, the intervention group had health coaching and usual care for 6 months, and the control group had usual care only. The outcome variables were HbA1c level and healthy diet for follow-up measurement in the third and sixth month. RESULTS The study discovered a significant decrease in HbA1c and health diet improvement after the 6-month health coaching. Patients in the intervention group decreased their daily intake of whole grains, fruits, meats and protein, and fats and oils while increasing their vegetables intake. CONCLUSIONS Health coaching may be conducive to the blood sugar control and healthy diet of patients with type 2 diabetes. Further study on health coaching with higher-quality evidence is needed.
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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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Lipids activate skeletal muscle mitochondrial fission and quality control networks to induce insulin resistance in humans.
Axelrod, CL, Fealy, CE, Erickson, ML, Davuluri, G, Fujioka, H, Dantas, WS, Huang, E, Pergola, K, Mey, JT, King, WT, et al
Metabolism: clinical and experimental. 2021;121:154803
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Insulin resistance is a key pathophysiological mechanism in the development and progression of type 2 diabetes. Abnormalities in lipid metabolism and ectopic lipid accumulation are known to directly contribute to the onset of insulin resistance. Authors hypothesised that lipid infusion would increase dynamin related protein 1 [a type of protein]-mediated mitochondrial fission in skeletal muscle independent of function and content, consequently reducing peripheral insulin sensitivity. The study included sedentary but otherwise healthy adults who were prospectively randomized to receive either lipid or saline infusion to isolate the direct contribution of fatty acids to skeletal muscle mitochondrial dynamics. Results show that mitochondrial fission and quality control networks are activated in response to lipid infusion which occurs independent of changes in mitochondrial content or capacity and contributes to the onset of insulin resistance in healthy humans. Authors conclude that treatments that limit lipid-induced activation of mitochondrial fission and/or quality control processes may have therapeutic value in the treatment of insulin resistance.
Abstract
BACKGROUND AND AIMS A diminution in skeletal muscle mitochondrial function due to ectopic lipid accumulation and excess nutrient intake is thought to contribute to insulin resistance and the development of type 2 diabetes. However, the functional integrity of mitochondria in insulin-resistant skeletal muscle remains highly controversial. METHODS 19 healthy adults (age:28.4 ± 1.7 years; BMI:22.7 ± 0.3 kg/m2) received an overnight intravenous infusion of lipid (20% Intralipid) or saline followed by a hyperinsulinemic-euglycemic clamp to assess insulin sensitivity using a randomized crossover design. Skeletal muscle biopsies were obtained after the overnight lipid infusion to evaluate activation of mitochondrial dynamics proteins, ex-vivo mitochondrial membrane potential, ex-vivo oxidative phosphorylation and electron transfer capacity, and mitochondrial ultrastructure. RESULTS Overnight lipid infusion increased dynamin related protein 1 (DRP1) phosphorylation at serine 616 and PTEN-induced kinase 1 (PINK1) expression (P = 0.003 and P = 0.008, respectively) in skeletal muscle while reducing mitochondrial membrane potential (P = 0.042). The lipid infusion also increased mitochondrial-associated lipid droplet formation (P = 0.011), the number of dilated cristae, and the presence of autophagic vesicles without altering mitochondrial number or respiratory capacity. Additionally, lipid infusion suppressed peripheral glucose disposal (P = 0.004) and hepatic insulin sensitivity (P = 0.014). CONCLUSIONS These findings indicate that activation of mitochondrial fission and quality control occur early in the onset of insulin resistance in human skeletal muscle. Targeting mitochondrial dynamics and quality control represents a promising new pharmacological approach for treating insulin resistance and type 2 diabetes. CLINICAL TRIAL REGISTRATION NCT02697201, ClinicalTrials.gov.
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The Effects of Korean Red Ginseng on Biological Aging and Antioxidant Capacity in Postmenopausal Women: A Double-Blind Randomized Controlled Study.
Chung, TH, Kim, JH, Seol, SY, Kim, YJ, Lee, YJ
Nutrients. 2021;13(9)
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Korean red ginseng (KRG) is produced by steaming and drying fresh, unpeeled ginseng. KRG has anti-cancer and antioxidant properties and consuming it improves immune system activity, fatigue symptoms, blood circulation, and memory function. The aim of this study was to investigate the effect of KRG primarily on biological aging and antioxidant capacity, also to evaluate how it affects clinical fatigue symptoms. This study comprised an 8-week, randomized, double-blind, placebo-controlled, clinical trial. Participants were randomly assigned to take a 500 mg KRG or placebo tablet four times daily. A total of 73 participants were enrolled in this study, 37 of whom were randomly placed in the KRG group and 36 of whom were randomly placed in the placebo group. Results show that taking 2 g/day of KRG for 8 weeks increased mtDNA copy number and total antioxidant status and reduced fatigue symptoms more than the placebo group. On the other hand, the mean low density lipoprotein cholesterol levels in the KRG group decreased from 136 to 127 mg/dL, but they did not decrease in the placebo group. However, this decrease was not statistically significant (p = 0.067). Authors conclude that their findings show that administering 2 g/day of KRG for 8 weeks increased the mtDNA copy number, increased antioxidant activity, and reduced fatigue symptoms more than the placebo.
Abstract
Postmenopausal women are vulnerable to aging and oxidative stress due to reduced estrogen. Previous studies have shown that Korean red ginseng (KRG) has beneficial effects on aging and antioxidant capacity. Therefore, we evaluated the effects of KRG on biological aging and antioxidant capacity in postmenopausal women. This study conducted a double-blinded, placebo-controlled clinical trial. The participants were randomly administered KRG or a placebo, and the following metrics were measured: mitochondria DNA (mtDNA) copy number as an indicator of biological aging and, total antioxidant status (TAS) as a marker of antioxidant capacity. Clinical symptoms of fatigue, as measured by the fatigue severity scale, were assessed before and after KRG administration. There were 63 participants, of whom 33 received KRG and 30 received a placebo. The mtDNA copy number (KRG group: 1.58 ± 2.05, placebo group: 0.28 ± 2.36, p = 0.023) and TAS (KRG group: 0.11 ± 0.25 mmol/L, placebo group: -0.04 ± 0.16 mmol/L, p = 0.011) increased and the fatigue severity scale (KRG group: -7 ± 12, placebo group: -1 ± 11, p = 0.033) decreased significantly more in the KRG group than the placebo group. KRG significantly increased the mtDNA copy number, total antioxidant status, and improved symptoms of fatigue in postmenopausal women.
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A Single Bout of Premeal Resistance Exercise Improves Postprandial Glucose Metabolism in Obese Men with Prediabetes.
Bittel, AJ, Bittel, DC, Mittendorfer, B, Patterson, BW, Okunade, AL, Abumrad, NA, Reeds, DN, Cade, WT
Medicine and science in sports and exercise. 2021;53(4):694-703
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Prediabetes is a metabolic condition defined by elevated fasting (impaired fasting glucose) and/or postprandial (impaired glucose tolerance) plasma glucose. The aim of this study was to determine the effects of a single bout of resistance exercise on postprandial glucose metabolism following a mixed meal in obese, sedentary men with prediabetes. This study is a randomised, cross-over study design which enrolled ten participants. Participants were aged 39-62 years, obese, and demonstrated insulin resistance with compensatory increases in beta cell function. Results show that a single bout of resistance exercise performed 4.5 hours before a mixed meal (as opposed to an oral glucose tolerance test) reduced total postprandial glucose appearance, increased insulin sensitivity, and reduced the glycaemic response to a mixed meal. However, it did not have effect on glucose oxidation in obese men with prediabetes. Improvements in insulin sensitivity were complemented by reduced postprandial insulin concentration. Authors conclude that further investigation is needed to elucidate how resistance exercise affects exogenous (meal) vs endogenous postprandial glucose metabolism, and if additional bouts of exercise (i.e. training) produce superior outcomes for this population.
Abstract
INTRODUCTION Prediabetes is a major risk factor for type 2 diabetes and cardiovascular diseases. Although resistance exercise (RE) is recommended for individuals with prediabetes, the effects of RE on postprandial glucose metabolism in this population are poorly understood. Therefore, the purpose of this study was to elucidate how RE affects postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation during the subsequent meal in sedentary men with obesity and prediabetes. METHODS We studied 10 sedentary men with obesity (body mass index, 33 ± 3 kg·m-2) and prediabetes by using a randomized, cross-over study design. After an overnight fast, participants completed either a single bout of whole-body RE (seven exercises, 3 sets of 10-12 repetitions at 80% one-repetition maximum each) or an equivalent period of rest. Participants subsequently completed a mixed meal test in conjunction with an intravenous [6,6-2H2]glucose infusion to determine basal and postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function). Skeletal muscle biopsies were obtained 90 min postmeal to evaluate pyruvate-supported and maximal mitochondrial respiration. Whole-body carbohydrate oxidation was assessed using indirect calorimetry. RESULTS RE significantly reduced the postprandial rise in glucose Ra and plasma glucose concentration. Postprandial insulin sensitivity was significantly greater after RE, whereas postprandial plasma insulin concentration was significantly reduced. RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation. CONCLUSION/INTERPRETATION A single bout of RE has beneficial effects on postprandial glucose metabolism in men with obesity and prediabetes by increasing postprandial insulin sensitivity, reducing the postprandial rise in glucose Ra, and reducing postprandial plasma insulin concentration.
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Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.
Peeke, PM, Greenway, FL, Billes, SK, Zhang, D, Fujioka, K
Nutrition & diabetes. 2021;11(1):6
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Time-restricted eating (TRE) has been identified as an effective method of losing weight in the face of rising obesity worldwide. Fasting for at least 12 hours has a beneficial effect on weight management and cardiometabolic health. Overnight fasting longer than 12 hours may result in fat-burning or ketosis. A high-fat, low-protein, low-carbohydrate snack during a 14-hour fast is believed not to raise blood sugar levels and helps with hunger management. This 8-week virtual, pilot, randomised, comparator-controlled clinical trial evaluated the benefits of following a commercial weight loss programme combined with TRE on body weight and fasting blood glucose (FBG) levels. The commercial weight loss programme included calculated calories and macronutrient content in their customised meal plans, as well as coaching and troubleshooting sessions. The participants were randomly assigned to 14-hour fasting (14:10) or 12-hour fasting (control). The 14:10 group also consumed 200 kcal of mixed nuts as a snack at hour 12 to determine the effect on blood glucose levels. After the intervention for 8 weeks, the 14:10 group showed a significant reduction in body weight (11kg) and FBG (8mg/dl), and the 12:12 group significantly lost 9kg of body weight and showed a non-significant reduction in FBG (3mg/dl). Participants with higher baseline FBG levels showed a greater reduction in FBG, indicating potential greater improvements in people with diabetes. A comparison of the two groups did not show a statistically significant difference in intervention effects. A fasting snack at 12 hours did not affect FBG in the 14:10 group, which may help adherence. Due to the exploratory nature of this study, larger robust studies are needed to assess the effectiveness of 14:10 and 12:12 time-restricted fasting regimens with commercial weight loss programmes. However, healthcare professionals can use the results of this study to understand the beneficial effects of different time-restricted fasting regimens on cardiometabolic health.
Abstract
BACKGROUND Time restricted eating (TRE) is an emerging dietary intervention for weight loss that is hypothesized to reinforce the metabolic benefits of nightly fasting/ketosis. This pilot study investigated the effectiveness of a daily 14-h metabolic fast (14:10 TRE beginning after dinner, a "fasting snack" at hour 12, and ending with breakfast 14 h later) combined with a commercial weight management program on body weight and fasting blood glucose (FBG) in individuals with obesity. We also investigated the effect of the low-calorie, high-fat, low-carbohydrate, and low-protein "fasting snack" on blood glucose. METHODS This 8-week, randomized, controlled, clinical trial included men and women (BMI ≥ 30 kg/m2) between June and October 2020. Study procedures were conducted remotely. Participants were randomized to 14:10 or 12-h TRE (12:12, active comparator) and prescribed a diet (controlled for calories and macronutrient composition) and exercise program that included weekly customized counseling and support. The primary outcome was change from baseline in body weight in the 14:10 group. RESULTS Of the 78 randomized participants, 60 (n = 30/group) completed 8 weeks. The LS mean change from baseline in weight in the 14:10 group was -8.5% (95% CI -9.6 to -7.4; P < 0.001) and -7.1% (-8.3 to -5.8; P < 0.001) in the 12:12 group (between group difference -1.4%; -2.7 to -0.2; P < 0.05). There was a statistically significant LS mean change from baseline to week 8 in FBG in the 14:10 group of -7.6 mg/dl (95% CI -15.1 to -0.1; P < 0.05) but not in the 12:12 group (-3.1 mg/dl, -10.0 to 3.7; P = NS). Both interventions resulted in a larger reduction in FBG in participants with elevated FBG (≥100 mg/dl) at baseline (both P < 0.05). CONCLUSIONS In participants with obesity who completed 8 weeks of the 14:10 TRE schedule combined with a commercial weight loss program, there was statistically significant and clinically meaningful weight loss and improvements in FBG.
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Gastric emptying of solutions containing the natural sweetener erythritol and effects on gut hormone secretion in humans: A pilot dose-ranging study.
Wölnerhanssen, BK, Drewe, J, Verbeure, W, le Roux, CW, Dellatorre-Teixeira, L, Rehfeld, JF, Holst, JJ, Hartmann, B, Tack, J, Peterli, R, et al
Diabetes, obesity & metabolism. 2021;23(6):1311-1321
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In recent years, erythritol, a non-calorie sweetener, has gained popularity due to the rise in obesity and Type 2 diabetes worldwide. The purpose of this randomised, placebo-controlled, double-blind, cross-over trial was to assess the effects of erythritol on the release of gut hormones, speed of gastric emptying, and the release of glucagon, motilin, and glucose-dependent insulinotropic polypeptide after erythritol administration. Erythritol in doses of ten, twenty-five, and fifty grams was well tolerated by the participants. The administration of erythritol induced a statistically significant dose-dependent stimulation of gut hormones such as plasma cholecystokinin, active glucagon‐like peptide‐1 and peptide tyrosine. Compared to the placebo, participants had slower gastric emptying with erythritol. Erythritol had no effect on the levels of motilin, glucose-dependent insulinotropic polypeptide, blood glucose, insulin, glucagon, blood lipids, or uric acid. Erythritol should be evaluated in larger, robust studies to determine whether it improves glycaemic control. However, healthcare professionals can use the results of this study to understand the potential uses of erythritol in the management of obesity and type 2 diabetes.
Abstract
AIM: To determine whether a dose-dependent effect in the stimulation of gut hormone release (plasma cholecystokinin [CCK], active glucagon-like peptide-1 [aGLP-1] and peptide tyrosine tyrosine [PYY]) is found for the natural sweetener erythritol. MATERIALS AND METHODS Twelve healthy, lean volunteers received solutions with 10, 25 or 50 g erythritol, or tap water enriched with 13 C-sodium acetate on four study days via a nasogastric tube in this randomized (active treatments), placebo-controlled, double-blind, cross-over trial. Blood samples and breath samples (13 C-sodium acetate method for measurement of gastric emptying [GE]) were taken at regular intervals, and sensations of appetite and gastrointestinal symptoms were rated. RESULTS We found (a) a dose-dependent stimulation of CCK, aGLP-1 and PYY, and slowing of GE, (b) no effect on blood glucose, insulin, motilin, glucagon or glucose-dependent insulinotropic polypeptide, (c) no effect on blood lipids and uric acid, and (d) no abdominal pain, nausea or vomiting. CONCLUSIONS Solutions with 10 and 50 g of erythritol stimulated gut hormone release. Emptying of erythritol-containing solutions from the stomach was slower compared with placebo. There was no effect on plasma glucose, insulin, glucagon, blood lipids or uric acid. All doses were well tolerated.