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

Study acronym: ProBiSat
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 4 of 22 entriesv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07715955
Lead Sponsor Maastricht University Medical Center
Collaborators: Winclove Probiotics B.V.
Conditions
(from sponsor)		 Healthy, Overweight (BMI > 25), Overweight , Obesity, Male, Female, Adults, Satiety and Food Intake, Gut Microbiota Modulation
Related terms Obesity, Overweight
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov