BridgeMD
New treatment option for Obesity and Overweight
Official title EXploratory Study on Postprandial Energy Metabolism
ClinicalTrials.gov ID: NCT06786052
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Man or woman;
- Age between 50 and 70 years old (inclusively);
- Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
- BMI between 27 and 34.9 kg/m2 (inclusively);
- Stable weight in the last 3 months (+/- 5% of total body weight);
You likely can't join if
- Participant with unstable medical or psychological conditions that, in the opinion of the investigator, could lead the participant to be...
- Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
- Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
- Tobacco consumption (or vaping equivalent) \> to 5 cigarettes per day and inability to restrict smoking or vaping on the exploratory days provided...
- Failure to comply with the exclusion period for another study specified in the "national volunteer file";
- Adult subject to a legal protection measure (guardianship, curatorship);
See the full eligibility criteria
Who can join
- Man or woman;
- Age between 50 and 70 years old (inclusively);
- Postmenopausal women, i.e. with amenorrhea for more than a year with no identified cause
- BMI between 27 and 34.9 kg/m2 (inclusively);
- Stable weight in the last 3 months (+/- 5% of total body weight);
- Waist circumference ≥ 80 cm for women, ≥ 94 cm for men;
- Sedentary to moderately active (less than 30 minutes of moderate physical activity, 3 times a week);
- 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...
- Agreeing to receive probiotics or placebo supplementation randomly;
- Able to understand the information given, read and write in French and have signed the informed consent form;
- Agreeing to submit to the entire study protocol;
- Having fibre consumption (through diet or supplementation) of less than 30g/day;
- Having a freezer to store stool samples before the visit.
What rules you out
- 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...
- Presence of pathology detectable on clinical examination and medical questioning that may interfere with the study endpoints;
- Alcohol consumption exceeding 30g of alcohol/day (1 dose of alcoholic beverage = 10g of alcohol) or abuse or dependence on another proven drug;
- 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;
- Failure to comply with the exclusion period for another study specified in the "national volunteer file";
- Adult subject to a legal protection measure (guardianship, curatorship);
- Person deprived of liberty by a judicial or administrative decision;
- Person who has exceeded the annual amount of compensation in the year for participation in research protocols;
- Person not affiliated to a social security system or beneficiary of a similar system;
- Absence of valid approved health proof(s) in the event of government measures in an exceptional epidemic situation;
- Person with a specific diet (vegetarian, lacto-vegetarian, vegan, high-protein, etc.);
- 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;
- Blood donation within 2 months prior to the screening visit;
- Claustrophobic to the point that indirect calorimetry measurement cannot be done;
- Person with limited venous access that can make it difficult to draw blood and insert a catheter;
- Type 1 or 2 diabetes;
- Systolic blood pressure ≥140 mmHg measured during the screening visit and mean systolic blood pressure from self-measurement over 3 days ≥140 mmHg;
- Diastolic blood pressure≥ 90 mmHg measured during the screening visit and mean diastolic blood pressure from self-measurement over 3 days ≥90 mmHg;
- Treatment for hypertension or dyslipidemia;
- Known endocrine pathology that may interfere with carbohydrate metabolism (uncontrolled dysthyroidism, acromegaly, hypercorticism, etc.);
- People with gastrointestinal pathologies with an inflammatory component or associated with malabsorption;
- People suffering from bloody diarrhoea;
- Exocrine pancreatic insufficiency;
- 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...
- Severe eating disorders (e.g., anorexia/bulimia, uncontrolled binge eating syndrome, noctophagia);
- Chronic kidney failure;
- Hepatocellular insufficiency;
- Immunocompromised individuals (e.g., those with AIDS, lymphoma, patients on long-term corticosteroid therapy, patients undergoing chemotherapy and allogeneic transplants);
- Patients with central venous catheters and post-surgical patients;
- Hematological, gastrointestinal, hepatic, neurological, or psychiatric clinically significant according to the investigator;
- Drug treatments for obesity in the last 3 months or prescribed for the duration of the study;
- 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...
- Taking antidepressants in the 2 months prior to the explorations or prescribed for the duration of the study;
- 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;
- Taking a treatment that may interfere with the study measures, according to the judgment of the co-investigating physicians of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Pierre-Bénite, Auvergne-Rhône-Alpes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pierre-Bénite, Auvergne-Rhône-Alpes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.