Effect of Probiotics on Appetite Regulation in Adults With Overweight/Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorMaastricht University Medical Center

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

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Maastricht University Medical Center

Lead sponsor

Winclove Probiotics B.V.

Collaborator