Impact of a Pro-diversity Gut Microbiota Diet After a Bariatric Surgery on Gut Microbiota, Eating Behaviour and Sensory Function

Official title

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

Overview

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.

Interventions

• Other Nutritional counseling
  Nutritional counseling

Primary outcome measures

• Microbiota diversity 12 months after surgery [Time frame: Primary outcome will be assessed three times : before the surgery, 6 and 12 months after]

Secondary outcome measures (12)

• Eating behaviour during a standardised, filmed and validated ad libitum buffet : Food intake [Time frame: Before the surgery and at 6 and 12 month after]
• Eating behaviour during a standardised, filmed and validated ad libitum buffet: Nutritional quality [Time frame: Before the surgery and at 6 and 12 month after]
• Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal microstructure [Time frame: Before the surgery and at 6 and 12 month after]
• Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal appreciation [Time frame: Before the surgery and at 6 and 12 month after]
• Eating behaviour and preferences : Behaviors [Time frame: Before the surgery and at 6 and 12 month after]
• Eating behaviour and preferences : Food preferences [Time frame: Before the surgery and at 6 and 12 month after]
• Appetite : hunger level [Time frame: Before the surgery and at 6 and 12 month after]
• Appetite : satiety [Time frame: Before the surgery and at 6 and 12 month after]
• Appetite : desire to eat [Time frame: Before the surgery and at 6 and 12 month after]
• Appetite : prospective consumption [Time frame: Before the surgery and at 6 and 12 month after]
• Appetite : meal appreciation [Time frame: Before the surgery and at 6 and 12 month after]
• Sensory functions : detection scores [Time frame: Before the surgery and at 6 and 12 month after]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

France · 3 centers

• Hospital Edouard Herriot, digestive surgery department — Lyon
• Centre de recherche en nutrition humaine de Rhône-Alpes — Pierre-Bénite
• Hôpital Lyon sud, Endocrinology Diabetes Nutrition department — Pierre-Bénite

Identifiers

NCT: NCT07268508 · 69HCL24_0033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗