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Recruiting NCT07715955

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

Conditions: Healthy, Overweight (BMI > 25), Overweight , Obesity, Male, Female, Adults, Satiety and Food Intake, Gut Microbiota Modulation

Sex: All
Ages: 20 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 98
Sponsor: Maastricht University Medical Center

Location: Maastricht University, Department of Nutrition and Movement Sciences Maastricht Limburg

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07715955). StuddyBuddy aggregates publicly available trial information.