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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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Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial.
Sundfør, TM, Tonstad, S, Svendsen, M
European journal of clinical nutrition. 2019;(7):1006-1014
Abstract
BACKGROUND/OBJECTIVES Weight loss diets affect food choices and control of eating. We evaluated the effects of intermittent energy restriction (IER) vs. continuous energy restriction (CER) on nutritional composition and eating behavior. SUBJECT/METHODS Individuals with BMI 30-45 kg/m2, abdominal obesity and ≥1 additional metabolic syndrome component were randomized to IER vs. CER with similar energy restriction. Of 112 participants, 98 completed weighed dietary records and the Three Factor Eating Questionnaire at baseline and three months. In statistical analysis, changes were adjusted for baseline values. RESULTS Weight loss, energy intake, and macronutrient composition were similar in the IER and CER groups. The CER group reported a greater increase in fruit and berries (45 g/day [95% CI 21, 71] vs. 2 g/day [-28, 33]; p = 0.047) and vegetables (135 g/day [91, 179] vs. 65 g/day [35, 96]; p = 0.010) than the IER group. Fiber intake increased in the CER compared to the IER group (1.0 g/MJ/day [0.8, 1.2] vs. 0.2 [0.0, 0.4]; p < 0.001). Sugar intake was reduced in the CER compared to the IER group (-2.2E% [-3.2, -2.2] vs. -0.1E% [-1.2, 1.0]; p = 0.007). Intakes of folate, potassium, and magnesium decreased more in the IER than the CER group, while vitamin C increased more in the CER group (all p-values <0.014). Both diets improved eating behavior scores, but cognitive restraint increased more in the CER than the IER group (34 [30, 39] vs. 17 [12, 22]; p = 0.013). CONCLUSIONS Men and women with obesity had more favorable changes in nutritional composition and eating behavior with CER than IER.
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Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial.
Risstad, H, Søvik, TT, Engström, M, Aasheim, ET, Fagerland, MW, Olsén, MF, Kristinsson, JA, le Roux, CW, Bøhmer, T, Birkeland, KI, et al
JAMA surgery. 2015;(4):352-61
Abstract
IMPORTANCE There is no consensus as to which bariatric procedure is preferred to reduce weight and improve health in patients with a body mass index higher than 50. OBJECTIVE To compare 5-year outcomes after Roux-en-Y gastric bypass (gastric bypass) and biliopancreatic diversion with duodenal switch (duodenal switch). DESIGN, SETTING, AND PARTICIPANTS Randomized clinical open-label trial at Oslo University Hospital, Oslo, Norway, and Sahlgrenska University Hospital, Gothenburg, Sweden. Participants were recruited between March 17, 2006, and August 20, 2007, and included 60 patients aged 20 to 50 years with a body mass index of 50 to 60. The current study provides the 5-year follow-up analyses by intent to treat, excluding one participant accepted for inclusion who declined being operated on prior to knowing to what group he was randomized. INTERVENTIONS Laparoscopic gastric bypass and laparoscopic duodenal switch. MAIN OUTCOMES AND MEASURES Body mass index and secondary outcomes including anthropometric measures, cardiometabolic risk factors, pulmonary function, vitamin status, gastrointestinal symptoms, health-related quality of life, and adverse events. RESULTS Sixty patients were randomly assigned and operated on with gastric bypass (n = 31) and duodenal switch (n = 29). Fifty-five patients (92%) completed the study. Five years after surgery, the mean reductions in body mass index were 13.6 (95% CI, 11.0-16.1) and 22.1 (95% CI, 19.5-24.7) after gastric bypass and duodenal switch, respectively. The mean between-group difference was 8.5 (95% CI, 4.9-12.2; P < .001). Remission rates of type 2 diabetes mellitus and metabolic syndrome and changes in blood pressure and lung function were similar between groups. Reductions in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and fasting glucose were significantly greater after duodenal switch compared with gastric bypass. Serum concentrations of vitamin A and 25-hydroxyvitamin D were significantly reduced after duodenal switch compared with gastric bypass. Duodenal switch was associated with more gastrointestinal adverse effects. Health-related quality of life was similar between groups. Patients with duodenal switch underwent more surgical procedures related to the initial procedure (13 [44.8%] vs 3 [9.7%] patients; P = .002) and had significantly more hospital admissions compared with patients with gastric bypass. CONCLUSIONS AND RELEVANCE In patients with a body mass index of 50 to 60, duodenal switch resulted in greater weight loss and greater improvements in low-density lipoprotein cholesterol, triglyceride, and glucose levels 5 years after surgery compared with gastric bypass while improvements in health-related quality of life were similar. However, duodenal switch was associated with more surgical, nutritional, and gastrointestinal adverse effects. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00327912.
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Long-term effects of a very-low-carbohydrate weight loss diet compared with an isocaloric low-fat diet after 12 mo.
Brinkworth, GD, Noakes, M, Buckley, JD, Keogh, JB, Clifton, PM
The American journal of clinical nutrition. 2009;(1):23-32
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Abstract
BACKGROUND Long-term weight loss and cardiometabolic effects of a very-low-carbohydrate, high-saturated-fat diet (LC) and a high-carbohydrate, low-fat diet (LF) have not been evaluated under isocaloric conditions. OBJECTIVE The objective was to compare an energy-controlled LC diet with an LF diet at 1 y. DESIGN Men and women (n = 118) with abdominal obesity and at least one additional metabolic syndrome risk factor were randomly assigned to either an energy-restricted (approximately 6-7 MJ) LC diet (4%, 35%, and 61% of energy as carbohydrate, protein, and fat, respectively) or an isocaloric LF diet (46%, 24%, and 30% of energy as carbohydrate, protein, and fat, respectively) for 1 y. Weight, body composition, and cardiometabolic risk markers were assessed. RESULTS Sixty-nine participants (59%) completed the trial: 33 in the LC group and 36 in the LF group. Both groups lost similar amounts of weight (LC: -14.5 +/- 1.7 kg; LF: -11.5 +/- 1.2 kg; P = 0.14, time x diet) and body fat (LC: -11.3 +/- 1.5 kg; LF: -9.4 +/- 1.2 kg; P = 0.30). Blood pressure, fasting glucose, insulin, insulin resistance, and C-reactive protein decreased independently of diet composition. Compared with the LF group, the LC group had greater decreases in triglycerides (-0.36 +/- 0.15 mmol/L; 95% CI: -0.67, -0.05 mmol/L; P = 0.011), increases in HDL cholesterol (0.23 +/- 0.09 mmol/L; 95% CI: 0.06, 0.40 mmol/L; P = 0.018) and LDL cholesterol (0.6 +/- 0.2 mmol/L; 95% CI: 0.2, 1.0 mmol/L; P = 0.001), and a greater but nonsignificant increase in apolipoprotein B (0.08 +/- 0.04 g/L; 95% CI: -0.004, 0.171 g/L; P = 0.17). CONCLUSIONS Under planned isoenergetic conditions, as expected, both dietary patterns resulted in similar weight loss and changes in body composition. The LC diet may offer clinical benefits to obese persons with insulin resistance. However, the increase in LDL cholesterol with the LC diet suggests that this measure should be monitored. This trial was registered with the Australian New Zealand Clinical Trials Registry at (http://www.anzctr.org.au) as ACTR 12606000203550.