About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Probiotic supplementation
- Placebo
Treatment groups
Sponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Winclove Probiotics B.V.
Collaborator