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

NCT07715955 | Recruiting

• 1 other identifier: METC 25-042
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Probiotics; Overweight; Obesity; Adults; Healthy; Satiety; Food intake; Gut microbiota; Gut microbiota composition; Gut microbiota modulation

Outcome Measures

Primary Outcomes (1)

• Ad libitum food intake

  The primary objective of the study is to investigate the effects of a combination of specifically selected probiotic strains in a new probiotic formulation on ad libitum food intake, in individuals with overweight and/or obesity. The primary endpoint is the difference in satiety measured by ad libitum food intake comparing the probiotic and control intervention.

  From enrolment to the end of the 16-week intervention

Secondary Outcomes (22)

• Satiety hormones

  From enrolment to the end of the 16-week intervention

• Subjective Appetite Sensation

  From enrolment to the end of the 16-week intervention

• Fecal microbial composition

  From enrolment to the end of the 16-week intervention

• Diet

  From enrolment to the end of the 16-week intervention

• Physical Activity

  From enrolment to the end of the 16-week intervention

Study Arms (2)

Probiotic supplement

EXPERIMENTAL

6g of probiotic supplement daily

Dietary Supplement: Probiotic supplementation

Placebo

PLACEBO COMPARATOR

6g of placebo daily

Other: Placebo

Interventions

Probiotic supplementation DIETARY_SUPPLEMENT

16-week consumption of 6 g/day of probiotic supplement

Probiotic supplement

Placebo OTHER

16-week consumption of 6 g/day of placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Winclove Probiotics B.V.: collaborator

Study Sites (1)

Maastricht University, Department of Nutrition and Movement Sciences

Maastricht, Limburg, 6200MD, Netherlands

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tanja Adam, PhD

CONTACT

+31433882123; t.adam@maastrichtuniversity.nl

Iris Boelen, MSc

CONTACT

+31433883644; iris.boelen@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: July 21, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): August 18, 2029
• Study Completion (Estimated): August 18, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

NL (1)