Correcting GUT MicrobioTa by Combined Supplementation of FibERs and BIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- 3-month variation of gut microbiota richness 3 months after the start of the different dietary interventions
研究概览
简要总结
Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated.
The investigators hypothesize that targeting the 3 months pre-surgery period by a calibrated dietary intervention, with fiber enrichment and biotin, will improve gut microbiota richness and subsequently improve subjects' metabolic health that may optimize post bariatric surgery outcomes.
The study is designed as a pilot, comparative, randomized, open-label trial with 4 arms: standard of care, biotin only, fibers only, biotin + fibers.
详细描述
This is a pilot open label study that aims to examine the efficacy of biotin supplementation with or without enriched soluble and insoluble fibers given during 3 months before the bariatric surgery, on gut microbiota composition and functional capacity to produce B vitamins (primary outcomes), compared to standard of care (e.g. patient preparation to bariatric surgery).
The study is a 4-arm clinical trial:
Arm 1: patients with usual follow-up (standard of care) receiving during 3 months before the surgery usual general dietary recommendations regarding balanced diet comprising legumes and fruits, meat or equivalent, dairy products and starch and bread Arm 2: Same usual general dietary recommendations PLUS Biotin 450 µg per day (1 capsule per day) during 3 months before the surgery.
Arm 3: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber, a powdered blend of fibers and prebiotics, during 3 months before the surgery Arm 4: Same usual general dietary recommendations PLUS 3 servings per day of PureLean® Fiber and Biotin 450 µg per day (1 capsule per day), during 3 months before the surgery.
There will be two periods: period 1 during the 3 months before bariatric surgery and period 3 after bariatric surgery (usual standard of care follow-up). The 4 groups will be compared before bariatric surgery and up to 6 months afterward
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and < 60 years
- •BMI ≥ 40 kg/m² or BMI > 35 kg/m² with at least one comorbidity belonging to metabolic syndrome (hyperglycemia (fasting glycemia > 1g/l, Non diabetic with HbA1C<7% without antidiabetic treatment), dyslipidemia (HDL-cholesterol <0.5 g/l or receiving treatment against dyslipidemia), or increased blood pressure (SBP >13, DBP>9 or treated by antihypertensive drug)), or sleep apnoea, weight stable (less than 3 kg variation in the 2 months before
- •Usual Fiber intake < 20g/day in food consumption evaluated by 24h recall
- •Signature of the informed consent
- •Effective contraception in women of childbearing age
- •Subject with health insurance (except AME)
排除标准
- •Patients receiving antibiotics (ATB) at the selection time or within the 2 previous months.
- •(if agreeing to participate to the study, the patients will be proposed randomization 3 months after stopping ATB)
- •Type 1 or type 2 diabetes
- •HIV, HBV, HCV
- •Gastrointestinal disease: Acute or chronic diarrhea (i.e. more than 3 liquid or fluid stools/day)
- •Previous history of gastrointestinal neoplasia or polyps
- •Factors that may affect the composition of the intestinal microbiota: Special Diet (exclusion diet, vegetarian diet), taking immunosuppressants (eg calcineurin inhibitors, corticosteroids, biological agents, etc.), taking transit modulators (osmotic or prebiotics such as lactulose).
- •Pregnancy or breastfeeding women
- •Subject under guardianship or curatorship
- •Subject deprived of their liberty by a judicial or administrative decision
- •Patient participating to another interventional clinical research (Jardé 1)
- •Subject physically unable to give his or her written consent
结局指标
主要结局
3-month variation of gut microbiota richness 3 months after the start of the different dietary interventions
时间窗: At the inclusion and 3 months after supplementation
Access to gut microbiota richness will be provided after gut microbiota sequencing (by INRAE) with the acquisition of a table comprising the number of genes as well as the record of bacterial genes implicated in synthesis and transport of biotin. Based on preclinical observation, it is expected that the arm 4 combining biotin and fibers will show the highest richness
次要结局
- Assess changes in body weight between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in BMI between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in waist circumference between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in fat mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in lean mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in visceral adipose tissue mass between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 month after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in blood pressure between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in insulin resistance markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in insulin sensitivity markers between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess change in Leptin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess change in Adiponectin between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in glucose between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in lipid profile between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in liver function between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess change in inflammatory marker (C-reactive protein) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in inflammatory markers (IL6, sCD14, IL1b, IL10, TNF-R) between the visit 3 months before surgery and the pre-surgery visit, the visit at 3 and 6 months after surgery.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in adipose tissue gene expression for biotin-dependent carboxylases and inflammatory genes(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in quality of life(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in emotional eating(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in physical activity(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in anxiety(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in sleep quality(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in stool consistency(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Assess changes in stool inflammatory markers(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Change in gut microbiota composition by quantitative metagenomics.(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Change in intestinal permeability by Zonuline dosage(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Change in intestinal permeability by LPS-binding protein dosage(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Systemic measurement of Biotin (B8),B6 and B9-vitamins(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)
- Systemic measurement of B12-vitamin(At the inclusion, 3 months after supplementation, 3, 6 and 12 months after surgery)