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Fecal microbial transplantation and fiber supplementation in patients with severe obesity and metabolic syndrome: a randomized double-blind, placebo-controlled phase 2 trial.
Mocanu, V, Zhang, Z, Deehan, EC, Kao, DH, Hotte, N, Karmali, S, Birch, DW, Samarasinghe, KK, Walter, J, Madsen, KL
Nature medicine. 2021;(7):1272-1279
Abstract
Fecal microbial transplantation (FMT) from lean donors to patients with obesity has been associated with metabolic benefits, yet results so far have been inconsistent. In this study, we tested the application of daily fiber supplementation as an adjunct to FMT therapy to modulate cardiometabolic outcomes. We performed a double-blind randomized trial in patients with severe obesity and metabolic syndrome receiving oral FMT, to test high-fermentable (HF) and low-fermentable (LF) fiber supplements (NCT03477916). Seventy participants were randomized to the FMT-HF (n = 17), FMT-LF (n = 17), HF (n = 17) and LF (n = 19) groups. The primary outcome was the assessment of change in insulin sensitivity from baseline to 6 weeks using the homeostatic model assessment (HOMA2-IR/IS). After 6 weeks, only patients in the FMT-LF group had significant improvements in HOMA2-IR (3.16 ± 3.01 at 6 weeks versus 3.77 ± 3.57 at baseline; P = 0.02). No difference in HOMA2-IR was observed over this period for those in the FMT-HF group (3.25 ± 1.70 at 6 weeks versus 3.17 ± 1.72 at baseline; P = 0.8), the HF group (3.49 ± 1.43 at 6 weeks versus 3.26 ± 1.33 at baseline; P = 0.8) or the LF group (3.76 ± 2.01 at 6 weeks versus 3.56 ± 1.81 at baseline; P = 0.8). Interventions were safe and well-tolerated with no treatment-attributed serious adverse events. We provide proof of concept for the use of a single-dose oral FMT combined with daily low-fermentable fiber supplementation to improve insulin sensitivity in patients with severe obesity and metabolic syndrome.
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Effect of soluble-viscous dietary fibre on coronary heart disease risk score across 3 population health categories: data from randomized, double-blind, placebo-controlled trials.
Vuksan, V, Sievenpiper, JL, Jovanovski, E, Jenkins, AL, Komishon, A, Au-Yeung, F, Zurbau, A, Ho, HVT, Li, D, Smircic-Duvnjak, L
Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme. 2020;(7):801-804
Abstract
We applied the Framingham risk equation in healthy, metabolic syndrome, and diabetes populations, following treatment with viscous fibre from konjac-based blend (KBB). KBB yielded reduction in estimated risk score by 16% (1.04 ± 0.03 vs. 0.87 ± 0.04, p < 0.01) in type 2 diabetes, 24% (1.08 ± 0.01 vs. 0.82 ± 0.02, p < 0.01) in metabolic syndrome, and 25% (1.09 ± 0.05 vs. 0.82 ± 0.06, p < 0.01) in healthy individuals. Drivers for decreased risk were improvements in blood cholesterol and systolic blood pressure. The composite coronary heart disease risk across populations was reduced 22% (p < 0.01). Novelty Viscous fibre from konjac-xanthan reduced 10-year relative coronary heart disease using Framingham Risk Score across the glycemic status spectrum.
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Addition of oat bran reduces HDL-C and does not potentialize effect of a low-calorie diet on remission of metabolic syndrome: A pragmatic, randomized, controlled, open-label nutritional trial.
Leão, LSCS, Aquino, LA, Dias, JF, Koifman, RJ
Nutrition (Burbank, Los Angeles County, Calif.). 2019;:126-130
Abstract
OBJECTIVES It is unclear whether addition of soluble fiber to a low-calorie diet potentializes weight loss and amelioration of metabolic syndrome (MetS). The aim of this study was to analyze the effects of oat bran on prevalence of MetS and associated disorders. METHODS A pragmatic, randomized controlled, 6-wk nutritional trial was carried out with 154 outpatients (mean age 47.6 ± 12.6 y of age). The intervention group (n = 83) received a low-calorie diet plus 40 g/d of oat bran; the control group (n = 71) received a low-calorie diet only. MetS parameters and prevalence were calculated and compared (using two-tailed statistical tests) before and after follow-up. RESULTS After follow-up, a significant but similar reduction was observed in MetS prevalence (40% reduction, 63% and 64.8% prevalence in intervention and control groups, respectively; P = 0.226), body mass index, body weight, waist circumference, systolic and diastolic blood pressures, triacylglycerides, and blood glucose levels in both groups (P < 0.05). Mean high-density lipoprotein cholesterol (HDL-C) was reduced in the intervention group (43.6 ± 9.6 to 41.2 ± 9.5 mg/dL; P = 0.025), but not in the control group (44.6 ± 10.5 to 44.5 ± 12.1 mg/dL; P = 0.890). There was no significant difference in any of the variables between the groups, although the P-value for HDL-C was almost significant (P = 0.078). Calorie and dietetic fiber intake during the 6-wk period were similar in both groups. CONCLUSIONS Daily consumption of oat bran did not potentialize the beneficial effects of a traditional low-calorie diet on the prevalence of MetS and associated disorders. Additionally, it reduced HDL-C.
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Effects of Whole Grain Wheat Bread on Visceral Fat Obesity in Japanese Subjects: A Randomized Double-Blind Study.
Kikuchi, Y, Nozaki, S, Makita, M, Yokozuka, S, Fukudome, SI, Yanagisawa, T, Aoe, S
Plant foods for human nutrition (Dordrecht, Netherlands). 2018;(3):161-165
Abstract
Metabolic syndrome is a risk factor for cardiovascular diseases and has become increasingly common in Japan. Epidemiological studies show inverse associations between intake of whole wheat grains and metabolic syndrome, but few dietary intervention trials have investigated the effect of whole wheat grain consumption. It was investigated whether a diet in which refined wheat bread (RW diet) was substituted by whole grain wheat bread (WW diet) would reduce visceral fat obesity in Japanese subjects. A randomized double-blind placebo-controlled intervention study was conducted in 50 Japanese subjects with body mass index (BMI) ≥ 23 kg/m2. Subjects were randomly assigned WW (WW group) or RW diets (RW group) for 12 weeks. Blood samples and computed tomography scans were obtained every 6th week. The WW group showed decrease (-4 cm2) in visceral fat area (VFA) (p < 0.05), whereas the RW group showed no significant changes. These time-dependent changes were significantly different between the groups. WW diet led to significant and safe reductions in VFA in subjects with BMI ≥ 23 kg/m2. WW diet may contribute to preventing visceral fat obesity.
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Increased fibre and reduced trans fatty acid intake are primary predictors of metabolic improvement in overweight polycystic ovary syndrome-Substudy of randomized trial between diet, exercise and diet plus exercise for weight control.
Nybacka, Å, Hellström, PM, Hirschberg, AL
Clinical endocrinology. 2017;(6):680-688
Abstract
OBJECTIVE Polycystic ovary syndrome (PCOS) is commonly affected by obesity. PCOS phenotypes are prone to increased waist/hip ratio, insulin resistance and dyslipidaemia. This substudy was undertaken to evaluate the effects of lifestyle interventions on metabolic biomarkers in overweight/obese PCOS women and the interventional effects of dietary components related to metabolic outcomes. DESIGN Randomized three-arm parallel study. PATIENTS Fifty-seven PCOS women body mass index (BMI >27 kg/m2 , age 18-40) were randomly assigned to diet (D, n = 19), exercise (E, n = 19) or diet plus exercise (DE, n = 19) in three-arm fashion over 16 weeks. The D group received nutritional counselling by a dietician to reduce their energy intake by at least 600 kcal/d. The E group received an ambulatory exercise regimen from a physiotherapist. The DE group had both interventions. MEASUREMENTS Self-reported food intake over 4 days, exercise pedometers, BMI, waist/hip ratio, blood pressure, body composition and oral glucose tolerance test were performed before and at the end of intervention. RESULTS BMI, waist circumference and total cholesterol were significantly reduced in the D and DE groups, as well as low-density lipoprotein and Homeostasis Model of Assessment index in the D group. In the E group, exercise was increased along with a decrease in BMI and waist circumference. The strongest predictor of reduced BMI was increased fibre intake (-0.44, P = .03), while a decrease in trans fatty acid intake predicted reduced insulinogenic index (0.44, P < .01). CONCLUSIONS Nutritional counselling with dieting is clearly effective to improve metabolic disturbances in overweight/obese women with PCOS. Increased fibre and reduced trans fatty acid intake are primary predictors of metabolic improvement and weight control.
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Assessing beans as a source of intrinsic fiber on satiety in men and women with metabolic syndrome.
Reverri, EJ, Randolph, JM, Kappagoda, CT, Park, E, Edirisinghe, I, Burton-Freeman, BM
Appetite. 2017;:75-81
Abstract
Dietary fiber is well-known for its satiety inducing properties. Adding fibers to mixed dishes is one way to increase fiber intake. However, adding fibers to foods versus including foods inherently containing fiber may reveal differing effects on satiety. The present study aimed to explore the satiety effects of adding fiber to a mixed meal versus using beans (Phaseolus vulgaris) as a source of intrinsic fiber in the meal. In this pilot study, 12 men and women with metabolic syndrome were randomly assigned to eat three standard meals in a crossover design on three different occasions that contained either no added fiber (control (NF)), extrinsic or added fiber (AF), or whole black beans as the source of intrinsic fiber (BN). Meals were matched for energy and macronutrient composition. Five hour postprandial subjective satiety was measured along with blood glucose, insulin, and the GI hormones, cholecystokinin (CCK) and peptide tyrosine tyrosine (PYY3-36). All meals induced fullness to a similar degree; however, the AF meal suppressed prospective consumption (F2,187 = 9.05, P = 0.0002) compared to the BN or NF meals. The NF meal tended to result in more satisfaction than the BN meal (F2,187 = 5.91, P = 0.003). The BN meal produced significantly higher postprandial CCK concentrations compared to the AF (F2,187 = 6.82, P = 0.001) and NF meals (F2,187 = 6.82, P = 0.002). Similar findings were observed for PYY3-36 response for BN > AF meal (F2,170 = 9.11, P < 0.0001). Postprandial insulin was significantly reduced after the BN meal, compared to the NF (F2,187 = 22.36, P < 0.0001) meal. These findings suggest that incorporating whole black beans into a meal has acute beneficial metabolic and GI hormone responses in adults with metabolic syndrome and are preferred over adding equivalent amounts of fiber from a supplement.
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Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial.
Ma, Y, Olendzki, BC, Wang, J, Persuitte, GM, Li, W, Fang, H, Merriam, PA, Wedick, NM, Ockene, IS, Culver, AL, et al
Annals of internal medicine. 2015;(4):248-57
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Abstract
BACKGROUND Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components. OBJECTIVE To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines. DESIGN Randomized, controlled trial from June 2009 to January 2014. (ClinicalTrials.gov: NCT00911885). SETTING Worcester, Massachusetts. PARTICIPANTS 240 adults with the metabolic syndrome. INTERVENTION Participants engaged in individual and group sessions. MEASUREMENTS Primary outcome was weight change at 12 months. RESULTS At 12 months, mean change in weight was -2.1 kg (95% CI, -2.9 to -1.3 kg) in the high-fiber diet group versus -2.7 kg (CI, -3.5 to -2.0 kg) in the AHA diet group. The mean between-group difference was 0.6 kg (CI, -0.5 to 1.7 kg). During the trial, 12 (9.9%) and 15 (12.6%) participants dropped out of the high-fiber and AHA diet groups, respectively (P = 0.55). Eight participants developed diabetes (hemoglobin A1c level ≥6.5%) during the trial: 7 in the high-fiber diet group and 1 in the AHA diet group (P = 0.066). LIMITATIONS Generalizability is unknown. Maintenance of weight loss after cessation of group sessions at 12 months was not assessed. Definitive conclusions cannot be made about dietary equivalence because the study was powered for superiority. CONCLUSION The more complex AHA diet may result in up to 1.7 kg more weight loss; however, a simplified approach to weight reduction emphasizing only increased fiber intake may be a reasonable alternative for persons with difficulty adhering to more complicated diet regimens. PRIMARY FUNDING SOURCE National Heart, Lung, and Blood Institute.
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Plasma alkylresorcinols C17:0/C21:0 ratio, a biomarker of relative whole-grain rye intake, is associated to insulin sensitivity: a randomized study.
Magnusdottir, OK, Landberg, R, Gunnarsdottir, I, Cloetens, L, Akesson, B, Landin-Olsson, M, Rosqvist, F, Iggman, D, Schwab, U, Herzig, KH, et al
European journal of clinical nutrition. 2014;(4):453-8
Abstract
BACKGROUND/OBJECTIVES Few studies have used biomarkers of whole-grain intake to study its relation to glucose metabolism. We aimed to investigate the association between plasma alkylresorcinols (AR), a biomarker of whole-grain rye and wheat intake, and glucose metabolism in individuals with metabolic syndrome (MetS). SUBJECTS/METHODS Participants were 30-65 years of age, with body mass index 27-40 kg/m(2) and had MetS without diabetes. Individuals were recruited through six centers in the Nordic countries and randomized to a healthy Nordic diet (ND, n=96), rich in whole-grain rye and wheat, or a control diet (n=70), for 18-24 weeks. In addition, associations between total plasma AR concentration and C17:0/C21:0 homolog ratio as an indication of the relative whole-grain rye intake, and glucose metabolism measures from oral glucose tolerance tests were investigated in pooled (ND+control) regression analyses at 18/24 weeks. RESULTS ND did not improve glucose metabolism compared with control diet, but the AR C17:0/C21:0 ratio was inversely associated with fasting insulin concentrations (P=0.002) and positively associated with the insulin sensitivity indices Matsuda ISI (P=0.026) and disposition index (P=0.022) in pooled analyses at 18/24 weeks, even after adjustment for confounders. The AR C17:0/C21:0 ratio was not significantly associated with insulin secretion indices. Total plasma AR concentration was not related to fasting plasma glucose or fasting insulin at 18/24 weeks. CONCLUSIONS The AR C17:0/C21:0 ratio, an indicator of relative whole-grain rye intake, is associated with increased insulin sensitivity in a population with MetS.
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Modulation of amino acid metabolic signatures by supplemented isoenergetic diets differing in protein and cereal fiber content.
Hattersley, JG, Pfeiffer, AF, Roden, M, Petzke, KJ, Hoffmann, D, Rudovich, NN, Randeva, HS, Vatish, M, Osterhoff, M, Goegebakan, Ö, et al
The Journal of clinical endocrinology and metabolism. 2014;(12):E2599-609
Abstract
CONTEXT Amino-acid (AA) metabolic signatures differ in insulin-resistant (IR) obese vs normal-weight subjects, improve after weight loss, and seem to predict the risk of type 2 diabetes. It is unknown whether weight-maintaining dietary measures aimed at influencing IR alter AA signatures of high-risk subjects. SETTING AND DESIGN In the randomized controlled Protein, Fiber and Metabolic Syndrome (ProFiMet) trial we investigated effects of four isoenergetic, moderately fat-reduced diets varying in protein and cereal-fiber contents on complete AA metabolic signatures in 76 group-matched overweight or obese high-risk subjects. We analyzed the relation of whole-body and hepatic IR with AA signatures, body fat composition and liver fat, after 0, 6, and 18 weeks of dietary intervention. Discrimination between diets was further enhanced by providing tailored dietary supplements for twice-daily consumption over 18 weeks in all groups. RESULTS Baseline AA, including branched-chain signatures significantly related to IR, liver fat, and visceral fat mass. Isoenergetic variation of protein and cereal-fiber dietary contents, but not fat restriction, significantly influenced IR, whereas the relation of AA with IR changed with all diets. The tryptophan ratio was significantly suppressed in obese vs overweight participants, but increased after 6 weeks of high cereal-fiber intake to a nonobese phenotype. Modeling analyses revealed diet-induced alterations of complex AA profiles to relate to 70% and 62% of changes in whole-body and hepatic IR. CONCLUSIONS We demonstrate that relatively short-term isoenergetic changes in the diet significantly alter the relation of AA signatures with IR, with possible implications on the determination and treatment of diabetes risk.
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Plasma alkylresorcinols reflect important whole-grain components of a healthy Nordic diet.
Magnusdottir, OK, Landberg, R, Gunnarsdottir, I, Cloetens, L, Åkesson, B, Önning, G, Jonsdottir, SE, Rosqvist, F, Schwab, U, Herzig, KH, et al
The Journal of nutrition. 2013;(9):1383-90
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Abstract
Biomarkers of dietary intake can be important tools in nutrition research. Our aim was to assess whether plasma alkylresorcinol (AR) and β-carotene concentrations could be used as dietary biomarkers for whole-grain, fruits and vegetables in a healthy Nordic diet (ND). Participants (n = 166), 30-65 y with a body mass index of 27-40 kg/m(2) and two more features of metabolic syndrome (International Diabetes Federation definition, slightly modified), were recruited through six centers in the Nordic countries and randomly assigned to an ND or control diet for 18 or 24 wk, depending on study center. Plasma AR and β-carotene were analyzed and nutrient intake calculated from 4-d food records. Median fiber intake increased in the ND group from 2.5 g/MJ at baseline to 4.1 g/MJ (P < 0.001) at end point (week 18 or 24), and median (IQR) fasting plasma total AR concentration increased from 73 (88) to 106 (108) nmol/L, or 45%, from baseline to end point (P < 0.001). The AR concentration was significantly higher in the ND group (P < 0.001) than in the control group at end point. β-Carotene intake tended to increase in the ND group (P = 0.07), but the plasma β-carotene concentration did not change significantly throughout the study and did not differ between the groups at follow-up. In conclusion, an ND resulted in higher dietary fiber intake and increased plasma total AR concentration compared with the control diet, showing that the total AR concentration might be a valid biomarker for an ND in which whole-grain wheat and rye are important components. No significant difference in plasma β-carotene concentrations was observed between the ND and control groups, suggesting that β-carotene may not be a sensitive enough biomarker of the ND.