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Evaluation of novel nutraceuticals based on the combination of oat beta-glucans and a green coffee phenolic extract to combat obesity and its comorbidities. A randomized, dose-response, parallel trial.
Mateos, R, García-Cordero, J, Bravo-Clemente, L, Sarriá, B
Food & function. 2022;(2):574-586
Abstract
Obesity and its associated comorbidities are a major public health concern worldwide. Reduced energy intake and increased physical activity interventions have limited success in the long term. Nutraceuticals might be an alternative means to help lose weight and reduce obesity-associated cardiometabolic risk factors without changes in the habitual diet. The objective of the present study was to comparatively evaluate the efficiency of nutraceuticals based on the combination of a decaffeinated green coffee bean extract (GCBE) and two types of oat beta-glucans (BG) with different physiochemical properties on obesity related biomarkers in overweight/obese subjects. A randomized, dose-response, parallel, blind study was carried out in four groups of subjects (n = 15 each) who consumed for 6 weeks, twice a day, a nutraceutical containing 3 g d-1 or 5 g d-1 doses of 35% or 70% BG and a fixed amount of GCBE providing 600 mg d-1 of phenols. 35% BG showed a 10 and 100 times higher molecular weight and viscosity, respectively, compared to 70% BG. Food intake, anthropometry and different cardiometabolic markers were assessed at the beginning and end of the intervention. According to the general model of variance with repeated measure analysis, the intervention caused positive changes in the levels of total cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, haemoglobin A1c, insulin, systolic blood pressure (SBP), total body fat percentage (TBF%), visceral fat percentage, and waist and hip circumferences without differences among the treatments, except for SBP and TBF%. Looking into the rates of change [(end value - beginning value)/beginning value] of these parameters, 5 g - 70% BG was the treatment that lowered TBF% the most. In conclusion, 5 g - 70% BG may be more effective in helping to lose weight and additionally, it produced the least bloating according to participants' subjective perception.
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Duodenal-Jejunal Bypass Liner for the management of Type 2 Diabetes Mellitus and Obesity: A Multicenter Randomized Controlled Trial.
Ruban, A, Miras, AD, Glaysher, MA, Goldstone, AP, Prechtl, CG, Johnson, N, Chhina, N, Al-Najim, W, Aldhwayan, M, Klimowska-Nassar, N, et al
Annals of surgery. 2022;(3):440-447
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Abstract
OBJECTIVE The aim of this study was to examine the clinical efficacy and safety of the duodenal-jejunal bypass liner (DJBL) while in situ for 12 months and for 12 months after explantation. SUMMARY BACKGROUND DATA This is the largest randomized controlled trial (RCT) of the DJBL, a medical device used for the treatment of people with type 2 diabetes mellitus (T2DM) and obesity. Endoscopic interventions have been developed as potential alternatives to those not eligible or fearful of the risks of metabolic surgery. METHODS In this multicenter open-label RCT, 170 adults with inadequately controlled T2DM and obesity were randomized to intensive medical care with or without the DJBL. Primary outcome was the percentage of participants achieving a glycated hemoglobin reduction of ≥20% at 12 months. Secondary outcomes included weight loss and cardiometabolic risk factors at 12 and 24 months. RESULTS There were no significant differences in the percentage of patients achieving the primary outcome between both groups at 12 months [DJBL 54.6% (n = 30) vs control 55.2% (n = 32); odds ratio (OR) 0.93, 95% confidence interval (CI): 0.44-2.0; P = 0.85]. Twenty-four percent (n = 16) patients achieved ≥15% weight loss in the DJBL group compared to 4% (n = 2) in the controls at 12 months (OR 8.3, 95% CI: 1.8-39; P = .007). The DJBL group experienced superior reductions in systolic blood pressure, serum cholesterol, and alanine transaminase at 12 months. There were more adverse events in the DJBL group. CONCLUSIONS The addition of the DJBL to intensive medical care was associated with superior weight loss, improvements in cardiometabolic risk factors, and fatty liver disease markers, but not glycemia, only while the device was in situ. The benefits of the devices need to be balanced against the higher rate of adverse events when making clinical decisions. TRIAL REGISTRATION ISRCTN30845205. isrctn.org; Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership reference 12/10/04.
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Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3.
Lugones-Sánchez, C, Recio-Rodríguez, JI, Menéndez-Suárez, M, Saz-Lara, A, Ramirez-Manent, JI, Sánchez-Calavera, MA, Gómez-Sánchez, L, Rodríguez-Sánchez, E, García-Ortiz, L, Evident Investigators Group,
Nutrients. 2022;(2)
Abstract
A balanced diet can help in the prevention of chronic diseases. The aim of this study was to evaluate the effect of an mHealth intervention on the distribution of macronutrients and the intake of food groups. A total of 650 participants were included in this multi-center, clinical, randomized, controlled trial (Evident 3 study). All participants were given brief advice about diet and exercise. The intervention group received, in addition, an app (Evident 3) for the self-recording of their diet and an activity tracker wristband for 3 months. Follow-up visits were performed at 3 and 12 months to collect the diet composition using the Food Frequency Questionnaire. There were decreases in the intake of total calories, fat, protein and carbohydrates in both groups throughout the study, without significant differences between them. The intervention group reduced the intake of cholesterol (-30.8; 95% CI -59.9, -1.7) and full-fat dairies (-23.3; 95% CI -42.8, -3.8) and increased the intake of wholemeal bread (3.3; 95% CI -6.7, 13.3) and whole-grain cereals (3.4; 95% CI -6.8, 13.7) with respect to the control group. No differences were found in the rest of the nutritional parameters. The brief advice is useful to promote a healthier diet, and the app can be a support tool to obtain changes in relevant foods, such as integral foods, and the intake of cholesterol. Trial registration: ClinicalTrials.gov with identifier NCT03175614.
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LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia.
Rader, DJ, Maratos-Flier, E, Nguyen, A, Hom, D, Ferriere, M, Li, Y, Kompa, J, Martic, M, Hinder, M, Basson, CT, et al
The Journal of clinical endocrinology and metabolism. 2022;(1):e57-e70
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Abstract
PURPOSE To evaluate the safety and potential efficacy of LLF580, a genetically engineered variant of human fibroblast growth factor-21, for triglyceride lowering, weight loss, and hepatic fat reduction. METHODS A multicenter, double-blind, parallel design trial in obese, mildly hypertriglyceridemic adults randomized (1:1) to LLF580 300 mg or placebo subcutaneously every 4 weeks for 3 doses. RESULTS Of 64 randomized study participants, 61 (mean ± SD: age 45 ± 11 years, 49% male, 80/15/5% Caucasian/African American/other, body mass index 36.1 ± 3.8 kg/m2) received LLF580 (n = 30) or placebo (n = 31) at 7 research sites in the United States. LLF580 lowered serum triglycerides by 54% (least square mean placebo adjusted change from baseline), total cholesterol 7%, low-density lipoprotein cholesterol 12%, and increased high-density lipoprotein cholesterol 36% compared with placebo (all P < 0.001) over 12 weeks. Substantial reduction of liver fat of 52% over placebo (P < 0.001) was also demonstrated in the setting of improved liver function tests including alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase, the composite enhanced liver fibrosis score, and N-terminal type III collagen propeptide (all P < 0.05). Insulin and C-peptide levels and insulin resistance by homeostatic model assessment for insulin resistance were all lower, and adiponectin higher with LLF580 treatment compared with placebo, whereas fasting glucose and glycated hemoglobin were unchanged. Reductions in biomarkers of bone formation without differences in markers of bone resorption were observed. LLF580 was generally safe and well tolerated, except for higher incidence of generally mild to moderate gastrointestinal adverse effects. CONCLUSIONS In obese, mildly hypertriglyceridemic adults, LLF580 was generally safe and demonstrated beneficial effects on serum lipids, liver fat, and biomarkers of liver injury, suggesting it may be effective for treatment of select metabolic disorders including hypertriglyceridemia and nonalcoholic fatty liver disease. Assessments of longer term safety and efficacy are warranted. CLINICALTRIALS.GOV IDENTIFIER NCT03466203.
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Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study.
Mähler, A, Klamer, S, Maifeld, A, Bartolomaeus, H, Markó, L, Chen, CY, Forslund, SK, Boschmann, M, Müller, DN, Wilck, N
Nutrients. 2022;(2)
Abstract
High salt intake ranks among the most important risk factors for noncommunicable diseases. Western diets, which are typically high in salt, are associated with a high prevalence of obesity. High salt is thought to be a potential risk factor for obesity independent of energy intake, although the underlying mechanisms are insufficiently understood. A high salt diet could influence energy expenditure (EE), specifically diet-induced thermogenesis (DIT), which accounts for about 10% of total EE. We aimed to investigate the influence of high salt on DIT. In a randomized, double-blind, placebo-controlled, parallel-group study, 40 healthy subjects received either 6 g/d salt (NaCl) or placebo in capsules over 2 weeks. Before and after the intervention, resting EE, DIT, body composition, food intake, 24 h urine analysis, and blood pressure were obtained. EE was measured by indirect calorimetry after a 12 h overnight fast and a standardized 440 kcal meal. Thirty-eight subjects completed the study. Salt intake from foods was 6 g/d in both groups, resulting in a total salt intake of 12 g/d in the salt group and 6 g/d in the placebo group. Urine sodium increased by 2.29 g/d (p < 0.0001) in the salt group, indicating overall compliance. The change in DIT differed significantly between groups (placebo vs. salt, p = 0.023). DIT decreased by 1.3% in the salt group (p = 0.048), but increased by 0.6% in the placebo group (NS). Substrate oxidation indicated by respiratory exchange ratio, body composition, resting blood pressure, fluid intake, hydration, and urine volume did not change significantly in either group. A moderate short-term increase in salt intake decreased DIT after a standardized meal. This effect could at least partially contribute to the observed weight gain in populations consuming a Western diet high in salt.
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A preliminary investigation of yoga as an intervention approach for improving long-term weight loss: A randomized trial.
Unick, JL, Dunsiger, SI, Bock, BC, Sherman, SA, Braun, TD, Wing, RR
PloS one. 2022;(2):e0263405
Abstract
OBJECTIVE Yoga targets psychological processes which may be important for long-term weight loss (WL). This study is the first to examine the feasibility, acceptability, and preliminary efficacy of yoga within a weight management program following WL treatment. METHODS 60 women with overweight or obesity (34.3±3.9 kg/m2, 48.1±10.1 years) were randomized to receive a 12-week yoga intervention (2x/week; YOGA) or a structurally equivalent control (cooking/nutrition classes; CON), following a 3-month behavioral WL program. Feasibility (attendance, adherence, retention) and acceptability (program satisfaction ratings) were assessed. Treatment groups were compared on weight change, mindfulness, distress tolerance, stress, affect, and self-compassion at 6 months. Initial WL (3-mo WL) was evaluated as a potential moderator. RESULTS Attendance, retention, and program satisfaction ratings of yoga were high. Treatment groups did not differ on WL or psychological constructs (with exception of one mindfulness subscale) at 6 months. However, among those with high initial WL (≥5%), YOGA lost significantly more weight (-9.0kg vs. -6.7kg) at 6 months and resulted in greater distress tolerance, mindfulness, and self-compassion and lower negative affect, compared to CON. CONCLUSIONS Study findings provide preliminary support for yoga as a potential strategy for improving long-term WL among those losing ≥5% in standard behavioral treatment.
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Pleurotus eryngii improves postprandial glycaemia, hunger and fullness perception, and enhances ghrelin suppression in people with metabolically unhealthy obesity.
Kleftaki, SA, Simati, S, Amerikanou, C, Gioxari, A, Tzavara, C, Zervakis, GI, Kalogeropoulos, N, Kokkinos, A, Kaliora, AC
Pharmacological research. 2022;:105979
Abstract
The aim of this study was to examine potential postprandial benefits of Pleurotus eryngii in nineteen volunteers with metabolically unhealthy obesity. An acute, randomized, crossover-designed trial comparing a meal with Pleurotus eryngii and a control meal was performed. The two meals matched in macronutrient and caloric content. Participants consumed both meals in random order after an overnight fast. Blood samples were drawn before and 30, 60, 90, 120, 150 and 180 min after meal consumption (in total 266 samples) to determine glucose, insulin, ghrelin, peptide YY, glucagon-like peptide-1 and glicentin. Visual analog scales measuring the subjective perception of hunger and fullness were completed at the same time points. The test meal resulted in lower glucose incremental area under the curve (iAUC). Additionally, the iAUC of the ghrelin response over time was substantially lower after the test meal (p = 0.033). Lower desire to eat and higher fullness was reflected by significantly lower hunger iAUC (p = 0.046) and higher fullness iAUC (p = 0.042) after the test meal. No differences in insulin, PYY, GLP-1 and glicentin were observed. Pleurotus eryngii can ameliorate postprandial glycaemia, appetite and regulate ghrelin levels at the postprandial state. This effect is attributed to the bioactive polysaccharides that inhibit the activity of enzymes catalysing carbohydrate hydrolysis, cause a delayed gastric emptying and glucose absorption.
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Expression of NF-κB, IL-6, and IL-10 genes, body composition, and hepatic fibrosis in obese patients with NAFLD-Combined effects of oleoylethanolamide supplementation and calorie restriction: A triple-blind randomized controlled clinical trial.
Tutunchi, H, Ostadrahimi, A, Saghafi-Asl, M, Roshanravan, N, Shakeri-Bavil, A, Asghari-Jafarabadi, M, Farrin, N, Mobasseri, M
Journal of cellular physiology. 2021;(1):417-426
Abstract
Nonalcoholic fatty liver disease (NAFLD) is one of the most common noncommunicable diseases worldwide. The present study aimed to investigate the effects of oleoylethanolamide (OEA) supplementation combined with calorie restriction on inflammation, body composition, and hepatic fibrosis among obese patients with NAFLD. In this 12-week randomized clinical trial, 76 obese patients newly diagnosed with NAFLD were randomly allocated into either OEA or placebo group. The weight-loss diet was also designed for both groups. Pre- and postintervention messenger RNA expression levels of the transcription factor nuclear factor-κB (NF-κB), interleukin-6 (IL-6) and IL-10, body composition, and NAFLD fibrosis score were assessed. At the end of the study, the OEA group showed lower NF-κB and IL-6 expression levels compared to the placebo (p < .01). However, IL-10 expression level was approximately twofold higher in the OEA group compared to the placebo group (p = .008). A significant reduction was observed in the fat mass of the OEA group compared to the placebo (p = .044) postintervention. In addition, OEA supplementation led to a significant increase in fat-free mass in the OEA group compared to the placebo (p = .032). A remarkable increase was observed in resting metabolic rate (RMR) in the OEA group (p = .009); however, it was not found in the placebo group. There were no significant between-group differences in RMR postintervention. In addition, no significant within-and between-group differences were observed in the NAFLD fibrosis score at the end of the trial. Treatment with OEA along with weight-loss intervention could significantly improve inflammation and body composition in patients with NAFLD.
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Effects of exenatide on urinary albumin in overweight/obese patients with T2DM: a randomized clinical trial.
Kang, C, Qiao, Q, Tong, Q, Bai, Q, Huang, C, Fan, R, Wang, H, Kaliannan, K, Wang, J, Xu, J
Scientific reports. 2021;(1):20062
Abstract
In this study, we investigated the effect of exenatide (EXE), a glucagon-like peptide (GLP)-1 receptor agonist, on kidney function, obesity indices, and glucose control in overweight/obese patients with type 2 diabetes mellitus (T2DM). A total of 159 overweight/obese patients with T2DM were randomized to the EXE group or insulin glargine (GLAR) control group for a total treatment period of 24 weeks. EXE intervention significantly reduced the urine albumin concentration (UAC) at week 12 and 24 endpoints (P < 0.001 at week 12 and 24). The levels of the anthropometric, glucose and lipid parameters (TG and HDL-c), and inflammation biomarkers (CRP and TNF-α) in the EXE group were improved at 12 weeks or 24 weeks, respectively. Meanwhile, a comparison between two groups showed significant changes in anthropometric parameters, glucose parameters, lipid parameters (TG and HDL-c), and Inflammation biomarkers (CRP, IL-6, and TNF-α). Serum fibroblast growth factor 21 (FGF21) was increased in the EXE group (P = 0.005) at week 24, and the change was significantly improved compared with GLAR group (P = 0.003). Correlation network analysis showed that FGF21 had a more central role in improving metabolism in the EXE group, and the change of FGF 21 was significantly negatively correlated with UAC at week 12 and week 24, respectively (r = - 0.297, P = 0.010; r = - 0.294, P = 0.012). Our results showed that EXE could help patients improve UAC, glycemic levels, and inflammatory biomarkers after a follow-up period of 24 weeks intervention. These EXE effects may be partly mediated by FGF 21, indicating that EXE is an effective and safe way to control albuminuria in overweight/obese patients with T2DM.
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Comparison Of Efficacy And Safety Profile Of Empagliflozin As A Combination Therapy In Obese Type 2 Diabetic Patients.
Babar, M, Hussain, M, Ahmad, M, Akhtar, L
Journal of Ayub Medical College, Abbottabad : JAMC. 2021;(2):188-191
Abstract
BACKGROUND Type 2 diabetes mellitus (T2DM) is a progressive disease due to multiple pathophysiological defects. Monotherapy alone cannot achieve adequate glycemic control and can lead to treatment failure. Empagliflozin, a sodium-glucose cotransporter2 (SGLT2) inhibitor improves glycemic control in patients with T2DM. There were limited studies to determine efficacy and safety profile of empagliflozin with conventional oral antidiabetic drugs (OADs) in Pakistan. So we investigated the efficacy and safety profile of empagliflozin as add-on therapy to metformin and sitagliptin in T2DM patients. METHODS In this comparative randomized placebo-controlled trial, 240 obese type 2 diabetic patients with inadequate glycaemic control (i.e, HbA1c ≥7%) with metformin and sitagliptin were allocated in to two groups. Patients in group B were given tab empagliflozin 10mg twice a day while patients in group A were given tab placebo for a period of 24 weeks. Changes in body weight, HbA1c, blood pressure were analysed pre and post treatment by using SPSS v23. RESULTS Empagliflozin caused a significant reduction in body weight -6.9±2.4 kg as compared to placebo -3.1±0.8 kg with p-value <0.001. This body weight reduction was further accompanied by reduction in systolic blood pressure -10.1±2.6 mmHg in empagliflozin group versus -5.3±2.5 mmHg in placebo group with p-value <0.001, and HbA1c -1.68±0.45 in empagliflozin group versus -0.1±0.06 in placebo group with p-value <0.001. There were 28.3% patients in empagliflozin group in whom HbA1c levels reduced <7% as compared to only 13.3% patients in placebo group (p-value 0.04). However no significant adverse effects were recorded in both study groups. CONCLUSIONS Empagliflozin as a combination therapy has good efficacy and safety profile in obese type 2 diabetic patients.