Actively Recruiting

Phase Not Applicable
Age: 25Years - 65Years
All Genders
NCT07268508

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

Led by Hospices Civils de Lyon · Updated on 2026-04-03

60

Participants Needed

3

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 25 and 65 years old
  • Undergoing either sleeve gastrectomy or Roux-en-Y gastric bypass
  • Grade 3 obesity (BMI 60 kg/m8) or BMI 35 kg/m8 with at least one comorbidity likely to improve after surgery, excluding type 2 diabetes
  • Signed consent form
  • Living less than 1 hour 30 minutes from the hospital
  • Effective and stable contraception for women who can have children
Not Eligible

You will not qualify if you...

  • Having type 2 diabetes
  • Contraindications to bariatric surgery
  • Gastrointestinal diseases with inflammation, gastroparesis, total gastrectomy, colectomy, exocrine pancreatic insufficiency, or endocrine diseases causing high blood sugar
  • Severe chronic kidney failure or liver failure
  • Claustrophobia
  • Pregnant or breastfeeding women
  • Using obesity treatments within 3 months before surgery
  • Taking corticoids, immunosuppressants, anabolic or growth hormones, or antibody treatments less than 3 months before inclusion
  • Daily use of laxatives or drugs that strongly affect gut microbiota; sporadic use allowed if stopped 3 weeks before inclusion
  • Following vegetarian, vegan, or gluten-free diets
  • Not speaking French
  • Already participating in another study
  • Donated blood in the last 2 months
  • No freezer access at home
  • Allergies or intolerances to foods offered in the study buffet

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Hospital Edouard Herriot, digestive surgery department

Lyon, France, 69310

Actively Recruiting

2

Centre de recherche en nutrition humaine de Rhône-Alpes

Pierre-Bénite, France, 69310

Not Yet Recruiting

3

Hôpital Lyon sud, Endocrinology Diabetes Nutrition department

Pierre-Bénite, France, 69310

Not Yet Recruiting

Loading map...

Research Team

J

Julie-Anne NAZARE

CONTACT

B

Berenice SEGRESTIN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here