-
1.
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.
-
2.
Computational modelling of self-reported dietary carbohydrate intake on glucose concentrations in patients undergoing Roux-en-Y gastric bypass versus one-anastomosis gastric bypass.
Ashrafi, RA, Ahola, AJ, Rosengård-Bärlund, M, Saarinen, T, Heinonen, S, Juuti, A, Marttinen, P, Pietiläinen, KH
Annals of medicine. 2021;(1):1885-1895
-
-
Free full text
-
Abstract
OBJECTIVES Our aim was to investigate in a real-life setting the use of machine learning for modelling the postprandial glucose concentrations in morbidly obese patients undergoing Roux-en-Y gastric bypass (RYGB) or one-anastomosis gastric bypass (OAGB). METHODS As part of the prospective randomized open-label trial (RYSA), data from obese (BMI ≥35 kg/m2) non-diabetic adult participants were included. Glucose concentrations, measured with FreeStyle Libre, were recorded over 14 preoperative and 14 postoperative days. During these periods, 3-day food intake was self-reported. A machine learning model was applied to estimate glycaemic responses to the reported carbohydrate intakes before and after the bariatric surgeries. RESULTS Altogether, 10 participants underwent RYGB and 7 participants OAGB surgeries. The glucose concentrations and carbohydrate intakes were reduced postoperatively in both groups. The relative time spent in hypoglycaemia increased regardless of the operation (RYGB, from 9.2 to 28.2%; OAGB, from 1.8 to 37.7%). Postoperatively, we observed an increase in the height of the fitted response curve and a reduction in its width, suggesting that the same amount of carbohydrates caused a larger increase in the postprandial glucose response and that the clearance of the meal-derived blood glucose was faster, with no clinically meaningful differences between the surgeries. CONCLUSIONS A detailed analysis of the glycaemic responses using food diaries has previously been difficult because of the noisy meal data. The utilized machine learning model resolved this by modelling the uncertainty in meal times. Such an approach is likely also applicable in other applications involving dietary data. A marked reduction in overall glycaemia, increase in postprandial glucose response, and rapid glucose clearance from the circulation immediately after surgery are evident after both RYGB and OAGB. Whether nondiabetic individuals would benefit from monitoring the post-surgery hypoglycaemias and the potential to prevent them by dietary means should be investigated.KEY MESSAGESThe use of a novel machine learning model was applicable for combining patient-reported data and time-series data in this clinical study.Marked increase in postprandial glucose concentrations and rapid glucose clearance were observed after both Roux-en-Y gastric bypass and one-anastomosis gastric bypass surgeries.Whether nondiabetic individuals would benefit from monitoring the post-surgery hypoglycaemias and the potential to prevent them by dietary means should be investigated.
-
3.
Traditional Brazilian diet and extra virgin olive oil reduce symptoms of anxiety and depression in individuals with severe obesity: Randomized clinical trial.
Canheta, ABS, Santos, ASEAC, Souza, JD, Silveira, EA
Clinical nutrition (Edinburgh, Scotland). 2021;(2):404-411
Abstract
RATIONAL & OBJECTIVE Although the relationship between obesity, anxiety and depression is known, the clinical benefits of nutrition therapy in individuals with obesity have been scarcely studied. This study assessed the effectiveness of a traditional Brazilian diet (DieTBra) and extra virgin olive oil (EVOO) on the symptoms of anxiety and depression in severe obese participants. METHOD This was a parallel randomized clinical trial in adults with severe obesity (Body Mass Index - BMI ≥ 35 kg/m2), DietBra Trial. Participants were randomized into three intervention groups in a ratio of 1: 1: 1 and followed up for 12 weeks. The three intervention groups were: 1) DieTBra, 2) 52 mL/day EVOO, and 3) DieTBra +52 mL/day EVOO. The symptoms of anxiety and depression were assessed by the Hospital Anxiety and Depression Scale. The outcome variables were: anxiety, depression and simultaneous anxiety and depression in the same individual. RESULTS 149 severe obese individuals were randomized. The mean BMI was 46.3 ± 6.5 kg/m2 with a mean age of 38.9 ± 8.7 years. After randomization, individuals on medication for depression and anxiety were excluded, totaling 129 at baseline, with 44:43:42 per group. At the end of 12 weeks 113 individuals completed the study. There was a significant reduction of symptoms for the three groups: EVOO, DieTBra and DieTBra + EVOO, respectively: anxiety 38.23% (p = 0.019), 45.83% (p=<0.014), 33.33% (p < 0.013) depression 55.17% (p=<0.001), 50.00% (p=<0.007), 34.61% (p=<0.035), and anxiety/depression 57.69% (p=<0.001), 66.67% (p=<0.014), 27.78% (p=<0.013). CONCLUSIONS Both DieTBra and olive oil interventions were effective in reducing symptoms of anxiety and depression in severe obese adults. These interventions can be integrated with clinical protocols for treatment of symptoms of anxiety and depression in severe obese individuals. TRIAL REGISTRATION Clinicaltrials.gov NCT02463435.
-
4.
The effect of a duodenal-jejunal bypass liner on lipid profile and blood concentrations of long chain polyunsaturated fatty acids.
Glaysher, MA, Ward, J, Aldhwayan, M, Ruban, A, Prechtl, CG, Fisk, HL, Chhina, N, Al-Najim, W, Smith, C, Klimowska-Nassar, N, et al
Clinical nutrition (Edinburgh, Scotland). 2021;(4):2343-2354
Abstract
BACKGROUND & AIMS Duodenal-jejunal bypass liners (DJBLs) prevent absorption in the proximal small intestine, the site of fatty acid absorption. We sought to investigate the effects of a DJBL on blood concentrations of essential fatty acids (EFAs) and bioactive polyunsaturated fatty acids (PUFAs). METHODS Sub-study of a multicentre, randomised, controlled trial with two treatment groups. Patients aged 18-65 years with type-2 diabetes mellitus and body mass index 30-50 kg/m2 were randomised to receive a DJBL for 12 months or best medical therapy, diet and exercise. Whole plasma PUFA concentrations were determined at baseline, 10 days, 6 and 11.5 months; data were available for n = 70 patients per group. RESULTS Weight loss was significantly greater in the DJBL group compared to controls after 11.5 months: total body weight loss 11.3 ± 5.3% versus 6.0 ± 5.7% (mean difference [95% CI] = 5.27% [3.75, 6.80], p < 0.001). Absolute concentrations of both EFAs, linoleic acid and α-linolenic acid, and their bioactive derivatives, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and docosahexaenoic acid, were significantly lower in the DJBL group than in the control group at 6 and 11.5 months follow-up. Total serum cholesterol, LDL-cholesterol and HDL-cholesterol were also significantly lower in the DJBL group. CONCLUSION One year of DJBL therapy is associated with superior weight loss and greater reductions in total serum cholesterol and LDL-cholesterol, but also depletion of EFAs and their longer chain derivatives. DJBL therapy may need to be offset by maintaining an adequate dietary intake of PUFAs or by supplementation. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02459561.
-
5.
Erythrocyte deformability and aggregation in morbidly obese women undergoing laparoscopic gastric bypass surgery and effects of oral omega-3 fatty acid supplementation.
Bakker, N, Schoorl, M, Demirkiran, A, Cense, HA, Houdijk, APJ
Clinical hemorheology and microcirculation. 2020;(3):303-311
Abstract
BACKGROUND An adequate erythrocyte function is vital for tissue oxygenation and wound healing. The erythrocyte membrane phospholipid composition plays an important role in erythrocyte function and administration of omega-3 fatty acids may provide a means to improve it. OBJECTIVE To investigate peri-operative erythrocyte function and effects of oral omega-3 fatty acids in morbidly obese women undergoing gastric bypass surgeryMETHODSFifty-six morbidly obese women undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery were randomized between a low calorie diet (LCD) during 2 weeks or oral omega-3 poly-unsaturated fatty acids (n-3 PUFAs) and a normal diet during 4 weeks. Peri-operative blood samples were analyzed with the Lorrca MaxSIS Ektacytometer for erythrocyte deformability and aggregability. RESULTS There were no significant differences in erythrocyte function between the groups at any time point. Only erythrocyte aggregability parameters were affected by surgery. At six month follow-up, aggregation index (AI) and cholesterol, glucose and insulin were significantly improved. CONCLUSIONS In this study, oral Omega-3 supplementation did not affect erythrocyte function compared to a LCD. Six months after surgery a significant improvement in AI and metabolic parameters was observed in both groups, contributing to a reduction in the risk at thromboembolic and cardiovascular complications.
-
6.
Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay.
Vicente Martin, C, Rabago Torre, LR, Castillo Herrera, LA, Arias Rivero, M, Perez Ferrer, M, Collado Pacheco, D, Martin Rios, MD, Barba Martin, R, Ramiro Martin, J, Vazquez-Echarri, J, et al
Surgical endoscopy. 2020;(6):2519-2531
Abstract
INTRODUCTION There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery. METHOD Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm). RESULTS The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% (p < 0.001) and 6.04 versus 1 (p < 0.001), respectively. The hospital stay was 7 days (p25-75: 5-8) B-arm and 7 days (p25-75: 5-9) in the C-arm (p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each. CONCLUSIONS The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration. TRAIL REGISTRY This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).
-
7.
Prefrontal Cortex Neuromodulation Enhances Frontal Asymmetry and Reduces Caloric Intake in Patients with Morbid Obesity.
Forcano, L, Castellano, M, Cuenca-Royo, A, Goday-Arno, A, Pastor, A, Langohr, K, Castañer, O, Pérez-Vega, KA, Serra, C, Ruffini, G, et al
Obesity (Silver Spring, Md.). 2020;(4):696-705
Abstract
OBJECTIVE The objective of this study was to test the feasibility of a combined intervention involving transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex (dlPFC) and cognitive training (CT). Short-term effects on food consumption, cognition, endocannabinoid (eCB) levels, and electroencephalogram (EEG) markers of future weight loss were explored. METHODS Eighteen healthy volunteers with morbid obesity were randomized in a double-blind, placebo-controlled, parallel trial. Participants received sham or active tDCS plus CT for four consecutive days. Cognitive performance, daily food intake, and eCB blood samples were collected before and after the intervention; EEG data were gathered before and after daily training. RESULTS The active tDCS + CT group reversed left-dominant frontal asymmetry and increased frontal coherence (FC) in the γ-band (30-45 Hz) after the intervention. The strength of the latter predicted BMI reduction. Additionally, a large intervention effect on food intake was shown in the active tDCS + CT group at follow-up (-339.6 ± 639 kcal on average), and there was a decrease of plasma eCB concentrations. CONCLUSIONS dlPFC modulation through tDCS + CT is an effective tool to restore right dominance of the dlPFC and enhance FC in patients with morbid obesity. Moreover, the effect of the strength of FC on BMI suggests that the interhemispheric FC at the dlPFC is functionally relevant for the efficient regulation of food choice.
-
8.
Effects of Extra Virgin Olive Oil (EVOO) and the Traditional Brazilian Diet on Sarcopenia in Severe Obesity: A Randomized Clinical Trial.
Aparecida Silveira, E, Danésio de Souza, J, Dos Santos Rodrigues, AP, Lima, RM, de Souza Cardoso, CK, de Oliveira, C
Nutrients. 2020;(5)
Abstract
BACKGROUND Nutritional interventions may have positive effects on sarcopenia and body composition. OBJECTIVE to evaluate the effectiveness of extra virgin olive oil (EVOO) consumption and a healthy traditional Brazilian diet (DieTBra) on improving sarcopenia indicators and reducing total body fat in severe obesity. METHODS A randomized controlled trial registered at ClinicalTrials.gov (NCT02463435) conducted with 111 severely obese participants randomized into three treatment groups-(1) EVOO (52 mL/day), (2) DieTBra, (3) DieTBra + EVOO (52 mL/day)-for 12 weeks. Body composition was assessed by dual-energy X-ray absorptiometry and sarcopenia by walking speed and handgrip strength. RESULTS Significant reductions in total body fat (p = 0.041) and body weight (p = 0.003) were observed in the DieTBra group. In the DietBra + olive oil group there was also a significant reduction in body weight (0.001) compared to the olive oil-only group. ANCOVA analyses showed reductions in total body fat in the DieTBra (p = 0.016) and DieTBra + olive oil (p = 0.004) groups. Individuals in the DieTBra group had significant improvements in their walking speed (p = 0.042) and handgrip strength (p = 0.044). CONCLUSIONS DieTBra contributes to improvements in handgrip strength, walking speed, and total body fat in severely obese adults. The major study was registered at ClinicalTrials.gov (NCT02463435).
-
9.
Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial.
Simonson, DC, Vernon, A, Foster, K, Halperin, F, Patti, ME, Goldfine, AB
Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery. 2019;(12):2052-2059
Abstract
BACKGROUND Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity. OBJECTIVES This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program. SETTING University medical center, United States. METHODS Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m2; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22). RESULTS At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies. CONCLUSIONS Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.
-
10.
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.