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Probiotic Regulation of Food Intake Through Satiety Stimulation and Gut Microbiota Modulation

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Netherlands
Maastricht University, Department of Nutrition and Movement Sciences
RECRUITING
Maastricht
Contact Information
Primary
Tanja Adam, PhD
t.adam@maastrichtuniversity.nl
+31433882123
Backup
Iris Boelen, MSc
iris.boelen@maastrichtuniversity.nl
+31433883644
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2029-08-18
Participants
Target number of participants: 98
Treatments
Experimental: Probiotic supplement
6g of probiotic supplement daily
Placebo_comparator: Placebo
6g of placebo daily
Related Therapeutic Areas
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Winclove Probiotics B.V.

This content was sourced from clinicaltrials.gov