Probiotic mix to see if it boosts fullness in adults who are overweight or have obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 16-week, randomized, placebo-controlled study enrolling adults with BMI of 25 or higher. Participants will take either a 6 g daily probiotic dose or placebo and visit the clinic at baseline, week 8, and week 16 for blood tests and stool collection, while keeping diaries and completing food questionnaires. The study aims to determine whether the probiotic formulation increases satiety hormones and shifts gut microbiota in a way that could influence food intake. The research includes an acute phase followed by a longer, proof-of-concept intervention in about 98 participants across arms. The sponsor is Maastricht University Medical Center, with collaboration from Winclove Probiotics B.V., at Maastricht University in the Netherlands.

Why it matters

Who can join: the full rules

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's running

• Maastricht University, Department of Nutrition and Movement Sciences
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Study coordinator: Tanja Adam, PhD
• Email: t.adam@maastrichtuniversity.nl
• Phone: +31433882123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.