Probiotic supplementation: 16-week consumption of 6 g/day of probiotic supplement
Placebo: 16-week consumption of 6 g/day of placebo
Study summary
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
Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Ad libitum food intake — From enrolment to the end of the 16-week intervention The primary objective of the study is to investigate the effects of a combination of specifically selected probiotic strains in a new probiotic formulation on ad libitum food intake, in individuals with overweight and/or obesity. The primary endpoint is the difference in satiety measured by ad libitum food intake comparing the probiotic and control intervention.
Trial sites (1)
Facility
City
Region
Status
Maastricht University, Department of Nutrition and Movement Sciences
Maastricht
Limburg
Recruiting
More Maastricht University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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