Bariatric Surgery, Obesity (Disorder)
Conditions
Keywords
Bariatric surgery, gut microbiota, sensory alteration, food preferences, weight loss maintenance
Brief summary
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
OTHERNutritional counseling
Nutritional counseling
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Randomisation will be stratified according to sex, type of surgery and age.
Intervention model description
* Arm with nutritional counselling promoting gut microbiota diversity * Arm with standard nutritional counselling
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota diversity 12 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating behaviour during a standardised, filmed and validated ad libitum buffet : Food intake | Before the surgery and at 6 and 12 month after | energy intake, macro- and micronutrient intake The items chosen during the buffet from the 17 items that will be offered will be noted. The quantities in g and calories consumed of each item will be estimated from the weighing of the plates before and after the buffet, the contribution of each of the items to the energy intake will also be evaluated. |
| Eating behaviour during a standardised, filmed and validated ad libitum buffet: Nutritional quality | Before the surgery and at 6 and 12 month after | Nutritional quality through analysis of the foods chosen and consumed Buffet items are classified (pre-defined classification) into seven groups based on their macronutrient content and energy density: starchy foods, meat and fish, fruits and vegetables, dairy products, sweet desserts, sauces, and sweetened beverages. They are also classified according to their fat, sugar, and protein content, and their energy density (4 groups). The quantities consumed in grams and as a percentage of energy intake per group will be assessed for each subject and per visit. |
| Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal microstructure | Before the surgery and at 6 and 12 month after | time spent selecting food at the buffet, duration of ingestion, ingestion speed, total meal duration, number of bites per minute, total number of bites and bites by food type, and food choices Several indicators will be assessed for the buffet's microstructure based on the analysis of videos taken during the buffet: \- Buffet time |
| Eating behaviour during a standardised, filmed and validated ad libitum buffet: Meal appreciation | Before the surgery and at 6 and 12 month after | time spent selecting food at the buffet, duration of ingestion, ingestion speed, total meal duration, number of bites per minute, total number of bites and bites by food type, and food choices Assessed with visual analog scale from 1(worse outcome) to 10 (better outcome) |
| Eating behaviour and preferences : Behaviors | Before the surgery and at 6 and 12 month after | binge eating using sub-scores from tthe BES (Binge Eating Scale) for binge eating BES : Binge Eating Scale - score from 0 to 46, score of 46 = highest level of binge eating disorder |
| Eating behaviour and preferences : Food preferences | Before the surgery and at 6 and 12 month after | Food preferences using the short version of the LFPQ (Leeds Food Preference Questionnaire) LFPQ : Leeds Food and Preference Questionnaire- score from 0 to 100 on preference or motivation for a type of food, high score = strong preference or motivation |
| Appetite : hunger level | Before the surgery and at 6 and 12 month after | Assessed using visual analog scales rated from 0 (worse outcome) to 10 (better outcome) on the following dimensions : hunger |
| Appetite : satiety | Before the surgery and at 6 and 12 month after | Assessed using visual analog scales rated rom 0 (worse outcome) to 10 (better outcome) on the following dimensions : feeling of satiety |
| Appetite : desire to eat | Before the surgery and at 6 and 12 month after | Assessed using visual analog scales rated from 0 (worse outcome) to 10 (better outcome) on the following dimensions : desire to eat |
| Appetite : prospective consumption | Before the surgery and at 6 and 12 month after | Assessed using visual analog scales rated from 0 (worse outcome) to 10 (better outcome) on the following dimensions : consommation |
| Appetite : meal appreciation | Before the surgery and at 6 and 12 month after | Assessed using visual analog scales rated rom 0 (worse outcome) to 10 (better outcome) on the following dimensions : meal appreciation |
| Sensory functions : detection scores | Before the surgery and at 6 and 12 month after | Assessed using Taste Strips tests |
| Sensory functions : intensity | Before the surgery and at 6 and 12 month after | Assessed using Taste Strips tests |
| Sensory functions : pleasantness | Before the surgery and at 6 and 12 month after | Assessed using Taste Strips tests |
| Sensory functions : edibility of tastes | Before the surgery and at 6 and 12 month after | Assessed using Taste Strips tests |
| Sensory functions : edibility of odors | Before the surgery and at 6 and 12 month after | Assessed using Taste Strips tests |
| Self-reported alterations in sensory functions | Before the surgery and at 6 and 12 month after | Assessed using dedicated questions |
| Body perception | Before the surgery and at 6 and 12 month after | Assessed using the BAQ questionnaire (Body Awareness Questionnaire) BAQ : Body Awarness Questionnaire - score from 13 to 65, score of 65 = positive assessment of one's body |
| Microbiota composition | Before the surgery and at 6 and 12 month after | Evaluated via gene function analysis from metagenomics data, metabolomics and short-chain fatty acid quantification |
| Microbiota function | Before the surgery and at 6 and 12 month after | Evaluated via gene function analysis from metagenomics data, metabolomics and short-chain fatty acid quantification |
| 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) | Blood sample to measure : Adiponectin µg/ml |
| Exhaled gas profiles | Before the surgery and at 6 and 12 month after | Assessed by volatolomic signatures |
| Cardio-metabolic profile parameters | Before the surgery and at 6 and 12 month after | BMI will be assessed |
| Vital parameters | Before the surgery and at 6 and 12 month after | Blood pressure |
| Nutritional status: Blood vitamin | Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after | Blood vitamin status : For the research, we will focus only whether or not the participant has a deficiency in one of the vitamins measured (yes/no variable). The vitamins assessed are : \- Vitamin B12 (pmol/L) should be above 145 pmol/L |
| Nutritional status : Blood mineral | Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after | Blood mineral status: * Calcium (mmol/L) should be above 64 mmol/L * Phosphor (mmol/L) should be above 0.81 mmol/L * Magnesium (mmol/L) should be above 0.66 mmol/L * Sodium (mmol/L) should be above 136 mmol/L * Potassium (mmol/L) should be above 3.4 mmol/L * Chlore (mmol/L) should be above 98 mmol/L |
| Nutritional status : Plasma fatty acid | Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after | Plasma fatty acid profile |
| Nutritional status : Protein | Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after | Protein status |
| Average energy | Before the surgery and at 6 and 12 month after | Assessed using 3-day dietary recall randomly selected from the 7 days preceding the visits |
| macronutrients intakes and proportions | Before the surgery and at 6 and 12 month after | Assessed using 3-day dietary recall randomly selected from the 7 days preceding the visits |
| micronutrients intakes and proportions | Before the surgery and at 6 and 12 month after | Assessed using 3-day dietary recall randomly selected from the 7 days preceding the visits |
| Mental health: Quality of life | Before the surgery and at 6 and 12 month after | Quality of life using the SF36 questionnaire SF36 - health status questionnaire - score from 0 to 100, score of 100 = excellent perceived health |
| Mental health: Self-confidence | Before the surgery and at 6 and 12 month after | Self-confidence and self-efficacy using the GSES GSES: Generalized Self-Efficacy Scale - score of 10 to 40, score of 40 = strong confidence in one's ability to effectively manage different life situations and challenges |
| Mental health: Depression | Before the surgery and at 6 and 12 month after | Depression with PHQ-9 PHQ-9: Patient Health Questionnaire -score from 0 to 27, score of 27=severe depression |
| Mental health: Anxiety | Before the surgery and at 6 and 12 month after | Anxiety assessment using GAD-7 GAD-7: Generalized Anxiety Disorder - if score \>7 then anxiety disorders should be suspected |
| Physical activity | Before the surgery and at 6 and 12 month after | Assessed using the short version of the IPAQ IPAQ: International Physical Activity Questionnaire - continuous daily energy expenditure score, high score means high AP The questionnaire allows the subject to be classified according to 3 levels of activity: inactive, moderate, high. |
| Emotions: positive and negative | Before the surgery and at 6 and 12 month after | positive and negative emotion assessed using the PANAS scale PANAS: Positive Affectivity and Negative Affectivity Scale - 2 scores from 10 to 50 - positive affectivity score = 50 best, negative affectivity score = 50 worst |
| Emotions: food phobias | Before the surgery and at 6 and 12 month after | food phobias using the FNS questionnaire FNS : Food Neophobia Scale -score from 10 to 70 - score of 70 = neophobia, i.e. less willingness to try new foods |
| Emotions: loneliness | Before the surgery and at 6 and 12 month after | loneliness using the ESUL questionnaire University of Laval Loneliness Scale - score from 20 to 80, score of 80 = most pronounced feeling of loneliness |
| Changes in stool consistency | Before the surgery and at 6 and 12 month after | Assessed using Bristol stool scale Bristol scale : 7 types of stools to choose from photo: type 1 = hard and lumpy stools, type 7 = completely liquid stools |
| Changes in stool frequency | Before the surgery and at 6 and 12 month after | Assessed using Bristol stool scale : 7 types of stools to choose from photo: type 1 = hard and lumpy stools, type 7 = completely liquid stools |
| Changes in gastrointestinal symptoms | Before the surgery and at 6 and 12 month after | Assessed using Bristol stool scale |
| Grade of hepatic steatosis | Before the surgery and at 12 month after | Evaluation by FibroScan® but only for patients who had a FibroScan® performed before surgery. |
| Grade of hepatic fibrosis | Before the surgery and at 12 month after | Evaluation by FibroScan® but only for patients who had a FibroScan® performed before surgery. |
| Hepatic metabolic flexibility | Before the surgery and at 6 and 12 month after | Assessed via the degree of alteration of MAMs (Mitochondia-Associated Membranes) in peripheral blood mononuclear cells (PBMCs), only for patients who had a FibroScan® performed before surgery. |
| Safety parameters | Before the surgery and at 6 and 12 month after | thyroid function: Thyroid function is assessed based on TSH levels in mIU/L (should be above 0.4 mIU/L and below 4.8 mIU/L), 2. The assessment for the research is whether the measures are within the limits or not (yes/no variable). |
| Compliance and follow-up of advice given during the intervention | until month 12 | Based on the three 24-hour reminders completed by participants before each visit, the dietitian will classify participants into three categories: good, average or poor compliance. |
Countries
France
Contacts
CONTACTJulie-Anne NAZARE
CONTACTBerenice SEGRESTIN
Outcome results
None listed