💬In plain words
What the trial is, and whether it could suit you
The goal of this 16-week randomised, placebo-controlled parallel study is to investigate the effect of a newly formed probiotic supplement on satiety and gut microbiota composition in healthy men and women with overweight or obesity form 20-70 years old. The main question it aims to answer is:
Does the probiotic supplement increase feelings of satiety and alter gut microbiota composition?
Participants will:
* Receive a daily dose of 6 g probiotic supplement (packed in sachets of 3 g) or placebo for 16 weeks.
* Visit the research unit 3 times at baseline, week 8 and week 16 of the intervention for blood draws and delivering fecal samples.
* Keep a study diary to report deviations from their daily habits and fill in food questionnaires.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Men and women, aged between 20-70 years
* BMI ³ 25 kg/m2
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit
Exclusion Criteria:
* Diabetic patients (type 1 and type 2)
* Abuse of drugs
* More than 2 units alcoholic consumptions per day for women and 3 for men
* Use of products or dietary supplements known to interfere with the main outcomes 3 months prior to the start of the study as judged by the principal investigators
* Gastrointestinal disease (including IBD and IBS)
* Use of an investigational product within another biomedical intervention trial within the previous 1-month
* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, autoimmune disease and rheumatoid arthritis
* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
* use of lipid- and glucose lowering medication, corticosteroid use
* Psychiatric diagnoses including clinical depression
* Intolerances or dietary habits that might interfere with the study (i.e. lactose intolerance or veganism)
* pregnancy
* smoking, vaping
* use of antibiotics up to 3 months prior to the study
💊
What it tests
- Probiotic supplementation
- Placebo
Maastricht University, Department of Nutrition and Movement Sciences
Maastricht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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