Randomised Controlled Trial Evaluating the Impact of a Pro-diversity Gut Microbiota Diet on Gut Microbiota, Eating Behaviour and Sensory Function in Patients Who Have Undergone Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Microbiota diversity 12 months after surgery
研究概览
简要总结
Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery.
The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand Bariatric surgery is the most effective treatment for long-term weight loss and reducing obesity-related health risks. It alters the gastrointestinal tract as well as metabolic and hormonal functions, influencing eating behaviour. However, weight loss outcomes and long-term maintenance vary between patients, likely due to changes in the gut microbiota. Dietary recommendations aimed at improving microbiota diversity could help support sustained weight loss after surgery.
The BariaGut Taste study aims to compare two dietary approaches following bariatric surgery: nutritional counselling promoting gut microbiota diversity versus standard nutritional counselling. One year after surgery, the study will evaluate differences in microbiota diversity, changes in food preferences and eating behaviours, sensory profiles (taste, smell), levels of digestive and gut hormones fasting, before and after eating, cardiometabolic parameters, mental health, physical activity, and more, to better understand the mechanisms that may explain variations in response to bariatric surgery.
The BariaGut Taste study is a prospective, randomized, controlled trial with two parallel groups, involving non-diabetic patients aged 25 to 65 y undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass. The trial will be conducted at the digestive surgery department of Edouard Herriot Hospital, the endocrinology-diabetes-nutrition department of Lyon Sud Hospital Center, and the Human Nutrition Research Center Rhône-Alpes. 60 participants are expected to be recruited, with 30 in each arm.
Participants will be enrolled before surgery during a routine care visit with the surgeon. They will then undergo a metabolic assessment visit conducted exclusively for research purposes. This visit will allow to collect baseline data on primary outcomes via blood, expired air, and stool samples, anthropometric measurements, indirect calorimetry, a battery of questionnaires (TFEQ-21, DEBQ, PHQ-9, SF36, GSES, PANAS, ESUL, BES, DERS, GAD-7, IPAQ, BAQ, GSRS, sensory alterations, Bristol and Likert scales, and FNS), computerized food preference tests (LFPQ), and a standardized, video-recorded ad libitum buffet.
Participants will be followed up at 3, 6, and 12 months after surgery through visits combining clinical care and research assessments. The dietary interventions specific to each group will be provided since the 3-month visit. The assessments conducted before surgery will be repeated at 6 and 12 months, also integrating clinical care objectives.
Additional blood, stool, and adipose tissue samples collected during surgery will be stored to create a biobank.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Randomisation will be stratified according to sex, type of surgery and age.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 25 and 65 years old
- •Undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass
- •With grade 3 obesity (BMI≥40 kg/m²) or with BMI≥35 kg/m² and at least one comorbidity likely to be improved after surgery, with the exception of type 2 diabetes
- •Signed consent form
- •Living less than an hour and 30 minutes from the hospital
- •Presence of effective and stable contraception for women of childbearing potential
排除标准
- •Type 2 diabetes
- •Presence of a contraindication to bariatric surgery
- •Presence of gastrointestinal pathologies with an inflammatory component, known gastroparesis, total gastrectomy, colectomy, exocrine pancreatic insufficiency, known endocrine pathologies inducing hyperglycaemia (uncontrolled dysthyroidism, acromegaly, hypercorticism, etc.), severe chronic renal insufficiency (< 30mL/min), or hepatocellular insufficiency
- •Claustrophobic
- •Pregnant or breastfeeding women
- •Taking an obesity treatment 3 months before surgery
- •Taking a corticoids, immunosuppression, anabolizing, or growing hormones, antibody treatments less than 3 months before inclusion
- •Daily taking of laxatives or drugs that can strongly interfere with the composition of the intestinal microbiota. If taken sporadically, the patient can be included at a distance (3 weeks) from the laxatives taken.
- •Specific diets (vegetarian, vegan or without gluten)
- •No French speaker
- •Already included in other study
- •Donated blood in the last two months
- •Without freezer access
- •With allergy or intolerance to food propose in ad libitum buffet
研究组 & 干预措施
Participants with nutritional counselling promoting gut microbiota diversity
Given the low amounts of food consumed during the first months after surgery, the specific nutritional recommendations for this group will be implemented starting 3 months post-surgery. Before 3 months, participants will receive the standard nutritional recommendations of routine care after bariatric surgery, identical to those given to the second group (see below).
From 3 months onwards, participants will be encouraged to increase the consumption of certain specific foods known for their benefits on the gut microbiota, particularly for promoting gut bacterial diversity, in addition to maintaining protein intake and paying attention to food textures. Summary sheets will be provided to help recall the recommendations.
干预措施: Nutritional counseling (Other)
Participants with standard nutritional counselling
The nutritional recommendations given to participants in this group are those applied in routine care within the Endocrinology, Diabetes, and Nutrition (EDN) Department for patients who have undergone sleeve gastrectomy or gastric bypass (Roux-en-Y).
These recommendations aim to maintain adequate protein intake and are adapted to the recent changes in their digestive tract (pureed then mashed food during the first postoperative month). During the first 6 months, patients' food intake is significantly below their nutritional needs. So it is important to pay close attention to hydration (away from meals) and macronutrient intake, especially proteins, as well as the progression of food texture and chewing.
结局指标
主要结局
Microbiota diversity 12 months after surgery
时间窗: Primary outcome will be assessed three times : before the surgery, 6 and 12 months after
The change in the diversity of the microbiota (shot gun metagenomic analysis, counting the number of microbial genes), between before surgery and one year after surgery (delta) between the two dietary intervention groups.
次要结局
- Eating behaviour during a standardised, filmed and validated ad libitum buffet : Food intake(Before the surgery and at 6 and 12 month after)
- Eating behaviour during a standardised, filmed and validated ad libitum buffet: Nutritional quality(Before the surgery and at 6 and 12 month after)
- Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal microstructure(Before the surgery and at 6 and 12 month after)
- Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal appreciation(Before the surgery and at 6 and 12 month after)
- Eating behaviour and preferences : Behaviors(Before the surgery and at 6 and 12 month after)
- Eating behaviour and preferences : Food preferences(Before the surgery and at 6 and 12 month after)
- Appetite : hunger level(Before the surgery and at 6 and 12 month after)
- Appetite : satiety(Before the surgery and at 6 and 12 month after)
- Appetite : desire to eat(Before the surgery and at 6 and 12 month after)
- Appetite : prospective consumption(Before the surgery and at 6 and 12 month after)
- Appetite : meal appreciation(Before the surgery and at 6 and 12 month after)
- Sensory functions : detection scores(Before the surgery and at 6 and 12 month after)
- Sensory functions : intensity(Before the surgery and at 6 and 12 month after)
- Sensory functions : pleasantness(Before the surgery and at 6 and 12 month after)
- Sensory functions : edibility of tastes(Before the surgery and at 6 and 12 month after)
- Sensory functions : edibility of odors(Before the surgery and at 6 and 12 month after)
- Self-reported alterations in sensory functions(Before the surgery and at 6 and 12 month after)
- Body perception(Before the surgery and at 6 and 12 month after)
- Microbiota composition(Before the surgery and at 6 and 12 month after)
- Microbiota function(Before the surgery and at 6 and 12 month after)
- Endocrine, digestive or intestinal hormones(Before the surgery and at 6 and 12 month after Fasting (all except acylated ghrelin), before the buffet and 1 hour after (adiponectin, total GLP1, ghrelin, acylated ghrelin, total PYY, glucagon, GIP and FGF-19))
- Exhaled gas profiles(Before the surgery and at 6 and 12 month after)
- Cardio-metabolic profile parameters(Before the surgery and at 6 and 12 month after)
- Vital parameters(Before the surgery and at 6 and 12 month after)
- Nutritional status: Blood vitamin(Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after)
- Nutritional status : Blood mineral(Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after)
- Nutritional status : Plasma fatty acid(Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after)
- Nutritional status : Protein(Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after)
- Average energy(Before the surgery and at 6 and 12 month after)
- macronutrients intakes and proportions(Before the surgery and at 6 and 12 month after)
- micronutrients intakes and proportions(Before the surgery and at 6 and 12 month after)
- Mental health: Quality of life(Before the surgery and at 6 and 12 month after)
- Mental health: Self-confidence(Before the surgery and at 6 and 12 month after)
- Mental health: Depression(Before the surgery and at 6 and 12 month after)
- Mental health: Anxiety(Before the surgery and at 6 and 12 month after)
- Physical activity(Before the surgery and at 6 and 12 month after)
- Emotions: positive and negative(Before the surgery and at 6 and 12 month after)
- Emotions: food phobias(Before the surgery and at 6 and 12 month after)
- Emotions: loneliness(Before the surgery and at 6 and 12 month after)
- Changes in stool consistency(Before the surgery and at 6 and 12 month after)
- Changes in stool frequency(Before the surgery and at 6 and 12 month after)
- Changes in gastrointestinal symptoms(Before the surgery and at 6 and 12 month after)
- Grade of hepatic steatosis(Before the surgery and at 12 month after)
- Grade of hepatic fibrosis(Before the surgery and at 12 month after)
- Hepatic metabolic flexibility(Before the surgery and at 6 and 12 month after)
- Safety parameters(Before the surgery and at 6 and 12 month after)
- Compliance and follow-up of advice given during the intervention(until month 12)