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NCT07898267

Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity

Sponsor: Second Affiliated Hospital of Nanchang University

View on ClinicalTrials.gov

Summary

Overweight and obesity are common metabolic disorders associated with increased risks of diabetes, cardiovascular disease, and other health problems. The gut microbiota plays an important role in regulating metabolism, inflammation, and intestinal health. Akkermansia, a beneficial gut bacterium, has been associated with metabolic health and may have potential benefits for weight management. This study aims to investigate the relationship between gut microbiota characteristics and overweight or obesity and to evaluate the efficacy and safety of Akkermansia supplementation in individuals with overweight or obesity. The study consists of two stages. The first stage is an observational study comparing gut microbiota characteristics between healthy individuals and individuals with overweight or obesity. The second stage is a randomized, double-blind, placebo-controlled clinical trial in which eligible participants with overweight or obesity will receive either Akkermansia supplementation or placebo once daily for 12 weeks, followed by follow-up through Week 24. The study will evaluate changes in body weight, metabolic health, gut microbiota characteristics, related metabolites, and safety outcomes. The findings may provide clinical evidence regarding the potential use of Akkermansia supplementation for the management of overweight and obesity.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2027-01-01

Completion Date

2029-09-01

Last Updated

2026-10-27

Healthy Volunteers

Yes

Conditions

Obesity & Overweight

Interventions

DIETARY_SUPPLEMENT

Akkermansia Supplement

Akkermansia supplementation will be administered orally once daily for 12 weeks to participants with overweight or obesity. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24.

DIETARY_SUPPLEMENT

Placebo Supplement

The placebo will be administered orally once daily for 12 weeks to participants with overweight or obesity. It will be identical to the Akkermansia supplement in appearance, color, odor, packaging, and administration method. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24.

This study includes healthy controls and participants with overweight or obesity. Eligibility criteria are as follows: Inclusion Criteria: 1. Healthy Controls: 1. Aged 18-60 years, any sex; 2. BMI between 18.5 and 24.9 kg/m²; 3. Body weight change \<5% within the past 3 months; 4. No obesity-related metabolic diseases, including type 2 diabetes mellitus, impaired glucose tolerance, hypertension, dyslipidemia, or nonalcoholic fatty liver disease; 5. No use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, weight-loss medications, glucocorticoids, or immunosuppressive agents within the past 3 months; 6. No gastrointestinal diseases that may significantly affect gut microbiota; 7. No severe diseases involving the cardiovascular, cerebrovascular, hepatic, renal, hematological, or endocrine systems, and no history of malignant tumors; 8. Not pregnant, lactating, or planning pregnancy; 9. Willing to participate voluntarily, provide fecal and blood samples and clinical data, and sign written informed consent. 2. Overweight/Obese Participants: 1. Aged 18-60 years, any sex; 2. BMI between 25.0 and 34.9 kg/m²; 3. Body weight change \<5% within the past 3 months; 4. Willing to maintain relatively stable dietary habits, physical activity, and daily routines during the study period; 5. Able to complete the 12-week intervention and 24-week follow-up; 6. Willing to provide fecal and blood samples and clinical data; 7. Willing to participate voluntarily and sign written informed consent. Exclusion Criteria: 1. Use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, or other microbiota-modulating products within the past 3 months; 2. Use of weight-loss medications within the past 3 months, including GLP-1 receptor agonists, orlistat, or metformin used for weight management; 3. Participation in commercial weight-loss programs or intensive lifestyle interventions within the past 3 months; 4. Previous bariatric surgery or planned bariatric surgery during the study period; 5. Type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy; 6. Uncontrolled hypertension, severe cardiovascular or cerebrovascular diseases, severe hepatic or renal dysfunction, malignant tumors, immunodeficiency, or active infections; 7. Gastrointestinal diseases that may significantly affect gut microbiota, including inflammatory bowel disease, short bowel syndrome, chronic diarrhea, severe constipation, or other clinically significant gastrointestinal disorders; 8. Pregnancy, lactation, or planning to become pregnant during the study; 9. Known allergy to any component of the study products; 10. Participation in other clinical studies that may affect study outcomes; 11. For participants entering the second-phase randomized controlled trial, high baseline Akkermansia abundance (Akkermansia abundance ≥1.5%) identified by gut microbiota testing; 12. Any condition considered unsuitable for participation by the investigator.

Locations (1)

No. 1, Minde Road, Donghu District, Nanchang University Second Affiliated Hospital

Nanchang, Jiangxi, China