nutritional counseling
OtherNutritional counseling
NCT Number: NCT07268508
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.
Interested in participating?
Request Info25 year–65 year
All sexes
Interventional
Not applicable
Hospital Edouard Herriot, digestive surgery department, Lyon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional counseling
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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:
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Taste Strips tests
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Taste Strips tests
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Taste Strips tests
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Taste Strips tests
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Taste Strips tests
Time frame: Before the surgery and at 6 and 12 month after
Assessed using dedicated questions
Time frame: 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
Time frame: Before the surgery and at 6 and 12 month after
Assessed using visual analog scales rated from 0 to 10 on the following dimensions: desire to eat
Time frame: Before the surgery and at 6 and 12 month after
Assessed using visual analog scales rated from 0 to 10 on the following dimensions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the surgery and at 6 and 12 month after
Assessed by volatolomic signatures
Time frame: Before the surgery and at 6 and 12 month after
BMI will be assessed
Time frame: Before the surgery and at 6 and 12 month after
Energy metabolism by indirect calorimetry
Time frame: Before the surgery and at 6 and 12 month after
postprandial plasma markers: We will assess: glycaemia (g/L)
Time frame: Before the surgery and at 6 and 12 month after
CRP
Time frame: Before the surgery and at 6 and 12 month after
Blood pressure
Time frame: 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 :
Time frame: Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after
Blood mineral status:
Time frame: Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after
Plasma fatty acid profile
Time frame: Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after
Protein status
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Bristol stool scale
Time frame: Before the surgery and at 12 month after
Evaluation by FibroScan® but only for patients who had a FibroScan® performed before surgery.
Time frame: Before the surgery and at 12 month after
Evaluation by FibroScan® but only for patients who had a FibroScan® performed before surgery.
Time frame: Before the surgery and at 6 and 12 month after
Behaviors (emotional eating and cognitive restraint) using score from the DEBQ (Dutch Eating Behavior Questionnaire) a DEBQ : Dutch Eating Behaviour Questionnaire : 3 sub-scores: cognitive restriction, reactivity to external stimuli and emotionality from 1 to 5, score 5 = strong impact of eating behavior
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Before the surgery and at 6 and 12 month after
time spent selecting food at the buffet
Time frame: Before the surgery and at 6 and 12 month after
duration of ingestion
Time frame: Before the surgery and at 6 and 12 month after
ingestion speed
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Likert scale Likert scale : 7 types of stools to choose from photo: type 1 = hard and lumpy stools, type 7 = completely liquid stools
Time frame: Before the surgery and at 6 and 12 month after
Assessed using gastrointestinal symptoms using GSRS Gastrointestinal Symptom Questionnaire - score 15 to 105, score 105=severe gastrointestinal symptoms
Time frame: Before the surgery and at 6 and 12 month after
complete blood count
Time frame: Before the surgery and at 6 and 12 month after
AST
Time frame: Before the surgery and at 6 and 12 month after
ALT
Time frame: Before the surgery and at 6 and 12 month after
gamma GT
Time frame: Before the surgery and at 6 and 12 month after
bilirubin
Time frame: Before the surgery and at 6 and 12 month after
alkaline phosphate
Time frame: Before the surgery and at 6 and 12 month after
creatinine
Time frame: Before the surgery and at 6 and 12 month after
uric acid
Time frame: Before the surgery and at 6 and 12 month after
ionogram results: Sodium (mmol/L) which should be between 136 and 145 Potassium (mmol/L) which should be between 3.4 and 4.5 Chlorine (mmol/L) which should be between 98 and 107 Bicarbonates (mmol/L) which should be between 22 and 29
Time frame: Before the surgery and at 6 and 12 month after
coagulation : prothrombin time
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Likert scale
Time frame: Before the surgery and at 6 and 12 month after
Assessed using gastrointestinal symptoms using GSRS : 15 questions with answers from No discomfort at all at Very severe discomfort (7 levels)
Time frame: Before the surgery and at 6 and 12 month after
Assessed using Likert scale
Time frame: Before the surgery and at 6 and 12 month after
gastrointestinal symptoms using GSRS
Time frame: Before the surgery and at 6 and 12 month after
total meal duration
Time frame: Before the surgery and at 6 and 12 month after
number of bites per minute
Time frame: Before the surgery and at 6 and 12 month after
total number of bites
Time frame: Before the surgery and at 6 and 12 month after
bites by food type
Time frame: Before the surgery and at 6 and 12 month after
food choices
Time frame: Before the surgery and at 6 and 12 month after
Calorie intake consumed per minute of the buffet
Time frame: Before the surgery and at 6 and 12 month after
ionogram results:
Anion gap = (Na+ + K+) - (HCO3- + Cl-) (mmol/L) which should be between 12 and 20
Time frame: 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 :
Ghrelin pg/ml acylated ghrelin pg/ml
Time frame: 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 :
GIP pmol/l total GLP-1 : pmol/L glucagon : pmol/L
Time frame: 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 :
total PYY : ng/L
Time frame: 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 :
leptin : ng/ml
Time frame: Before the surgery and at 6 and 12 month after
We will assess: insulin (mU/L)
Time frame: Before the surgery and at 6 and 12 month after
We will assess: triglycerides (mmol/L), HDL (mmol/L), LDL (mmol/L), ApoB (mmol/L), sphingolipid (mmol/L) and unesterified fatty acid(mmol/L)
Time frame: Before the surgery and at 6 and 12 month after
we will calculate: HOMA-IR (=insulin*glycarmia/22.5) and the total cholesterol/HDL cholesterol ratio.
Time frame: Before the surgery and at 6 and 12 month after
postprandial plasma markers: We will assess: insulin (mU/L)
Time frame: 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 :
Time frame: 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 :
Time frame: 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 :
Time frame: Before the surgery and at 6 (except plasma fatty acid profile) and 12 month after
Blood mineral status:
Time frame: Before the surgery and at 6 and 12 month after
thyroid function: Thyroid function is assessed based on free thyroxine in pmol/L (should be above 11.9 pmol/L and below 21.9 pmol/L)
The assessment for the research is whether the measures are within the limits or not (yes/no variable).
Time frame: Before the surgery and at 6 and 12 month after
thyroid function: Thyroid function is assessed based on free triiodothyronine in pmol/L (should be above 3.1 pmol/L and below 6.8 pmol/L).
The assessment for the research is whether the three measures are within the limits or not (yes/no variable).
Time frame: Before the surgery and at 6 and 12 month after
Waist-to-hip ratio will be assessed
Time frame: Before the surgery and at 6 and 12 month after
resting heart rate
Time frame: Before the surgery and at 6 and 12 month after
coagulation : activated partial thromboplastin time
Time frame: Before the surgery and at 6 and 12 month after
coagulation : fibrinogen
Time frame: Before the surgery and at 6 and 12 month after
We will assess: total cholesterol (g/L)
Time frame: Before the surgery and at 6 and 12 month after
We will assess: HbA1c (mmol/mol),
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
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
Acronym: BariaGut Taste
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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