Effect of Probiotics on Appetite Regulation in Adults With Overweight/Obesity
Recruiting · NCT07715955 · Interventional (participants receive a specific treatment) · Lead sponsor: Maastricht University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Maastricht University, Department of Nutrition and Movement Sciences - Maastricht, Limburg, Netherlands