Clinical trial NCT06786052: EXploratory Study on Postprandial Energy Metabolism
Official title: Efficacy of Probiotics on Postprandial Energy Metabolism of Adults With Overweight or Obesity: an EXploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obesity and Overweight
Moderately Obese
Keywords: Metabolic health
Probiotics
Postprandial metabolism
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: Centre de recherche en nutrition humaine de Rhône-Alpes
First posted: 2025-01-22
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This exploratory, double-blinded clinical trial on 66 randomized adults aged 50 to 70 years with moderate overweight or obesity but considered metabolically healthy will consist of comparing metabolic and microbiota parameters before and after 3 months of consumption of a probiotic or a placebo.

Detailed description: This study will focus on adults (men and postmenopausal women) aged 50 to 70 years who are overweight or moderately obese (BMI between 27 and 34.9 kg/m2) and considered metabolically healthy.

66 participants will be recruited according to the following inclusion and exclusion criteria. There will be a total of 5 visits and the study participation will last about 3.5 months.

The main hypothesis is that daily supplementation of the probiotics for 3 months in the defined population will improve certain parameters related to the cardiometabolic profile such as glucose tolerance and lipemia during the postprandial phase, compared to the placebo group.

Eligibility criteria: Inclusion Criteria:

1. Man or woman;
2. Age between 50 and 70 years old (inclusively);
3. Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
4. BMI between 27 and 34.9 kg/m2 (inclusively);
5. Stable weight in the last 3 months (+/- 5% of total body weight);
6. Waist circumference ≥ 80 cm for women, ≥ 94 cm for men;
7. Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week);
8. Agreeing not to consume fermented or supplemented foods (including bifidus yogurts and other foods supplemented with probiotics), dietary supplements (high in fiber (prebiotics), high protein, or other food supplements that may interact with the gut microbiota or energy metabolism), laxatives and any substance that can control metabolic parameters such as weight, blood glucose or lipid metabolism during the study period (from the screening visit);
9. Agreeing to receive probiotics or placebo supplementation randomly;
10. Able to understand the information given, read and write in French and have signed the informed consent form;
11. Agreeing to submit to the entire study protocol;
12. Having fibre consumption (through diet or supplementation) of less than 30g/day;
13. Having a freezer to store stool samples before the visit.

Exclusion Criteria:

1. Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be non-compliant or uncooperative during the study or that could compromise the safety or participation in the study (according to articles L.1121-6, L.1121-8, L.1121-9 and L1122-1-2 of the Public Health Code);
2. Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
3. Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
4. Tobacco consumption (or vaping equivalent) \> to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided for in the protocol;
5. Failure to comply with the exclusion period for another study specified in the "national volunteer file";
6. Adult subject to a legal protection measure (guardianship, curatorship);
7. Person deprived of liberty by a judicial or administrative decision;
8. Person who has exceeded the annual amount of compensation in the year for participation in research protocols;
9. Person not affiliated to a social security system or beneficiary of a similar system;
10. Absence of valid approved health proof(s) in the event of government measures in an exceptional epidemic situation;
11. Person with a specific diet (vegetarian, lacto-vegetarian, vegan, high-protein, etc.);
12. People consuming food supplements (pre or probiotics, or minerals (divalent cations such as magnesium and calcium)) regularly during the month prior to the screening visit;
13. Blood donation within 2 months prior to the screening visit;
14. Claustrophobic to the point that indirect calorimetry measurement cannot be done;
15. Person with limited venous access that can make it difficult to draw blood and insert a catheter;
16. Type 1 or 2 diabetes;
17. Systolic blood pressure≥ 140 mmHg;
18. Diastolic blood pressure≥ 90 mmHg;
19. Treatment for hypertension or dyslipidemia;
20. Known endocrine pathology that may interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, etc.);
21. People with gastrointestinal pathologies with an inflammatory component or associated with malabsorption;
22. People suffering from bloody diarrhoea;
23. Exocrine pancreatic insufficiency;
24. People who have had intestinal or abdominal surgery (apart from appendectomy and simple hernias), bariatric surgery (gastric banding, calibrated vertical gastroplasty and sleeve gastrectomy accepted if done more than 5 years ago);
25. Severe eating disorders (e.g., anorexia/bulimia, uncontrolled binge eating syndrome, noctophagia);
26. Chronic kidney failure;
27. Hepatocellular insufficiency;
28. Immunocompromised individuals (e.g., those with AIDS, lymphoma, patients on long-term corticosteroid therapy, patients undergoing chemotherapy and allogeneic transplants);
29. Patients with central venous catheters and post-surgical patients;
30. Hematological, gastrointestinal, hepatic, neurological, or psychiatric clinically significant according to the investigator;
31. Drug treatments for obesity in the last 3 months or prescribed for the duration of the study;
32. Taking antibiotics in the month preceding the explorations (for the so-called common antibiotics of the beta-lactam family) or in the 3 months preceding the explorations according to the investigator's judgment (for other families of antibiotics);
33. Taking antidepressants in the 2 months prior to the explorations or prescribed for the duration of the study;
34. Daily intake of laxatives in the 3 months prior to explorations or other medications that may strongly interfere with the composition of the gut microbiota;
35. Taking a treatment that may interfere with the study measures, according to the judgment of the co-investigating physicians of the study.

Primary outcomes:
measure: Change from baseline in postprandial triglyceridemia after 3 months
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in vital parameter
timeFrame: 12 weeks
measure: Change in vital parameter
timeFrame: 12 weeks
measure: Change in anthropometric measurement
timeFrame: 12 weeks
measure: Change in anthropometric measurement
timeFrame: 12 weeks
measure: Change in blood lipid concentrations from baseline
timeFrame: 12 weeks
measure: Change in blood metabolic parameters from baseline
timeFrame: 12 weeks
measure: Change in body composition
timeFrame: 12 weeks
measure: Change in inflammatory parameters
timeFrame: 12 weeks
measure: Change in intestinal barrier integrity biomarker
timeFrame: 12 weeks
measure: Change in safety plasma concentration
timeFrame: 12 weeks
measure: Change in fasting exhaled gases
timeFrame: 12 weeks
measure: Change in complete blood count
timeFrame: 12 weeks
measure: Change in gut microbiota
timeFrame: 12 weeks
measure: Change in postprandial kinetics of metabolic parameters
timeFrame: 12 weeks
measure: Change in postprandial kinetics of metabolic parameters
timeFrame: 12 weeks
measure: Change in postprandial kinetics of metabolic parameters
timeFrame: 12 weeks
measure: Change in postprandial kinetics of metabolic parameters
timeFrame: 12 weeks
measure: Change in postprandial triglyceride levels and kinetics
timeFrame: 12 weeks
measure: Change in plasma metabolome
timeFrame: 12 weeks
measure: Assessment of average daily food intake
timeFrame: 12 weeks
measure: Change in resting energy metabolism
timeFrame: 12 weeks
measure: Assessment of digestive tolerance
timeFrame: 12 weeks
measure: Evaluation of changes in stool assessment
timeFrame: 12 weeks
measure: Physical Activity Assessment
timeFrame: 12 weeks
measure: Evaluation of eating behaviour
timeFrame: 12 weeks
measure: Assessment of general well-being
timeFrame: 12 weeks
measure: Assessment of stress level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes (CRNH-RA)
state: Auvergne-Rhône-Alpes
Study officials:
References: