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Starting soon Not applicable

Probiotic for Weight Management in Overweight and Obese Adults

NCT07507929 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-03-20
Last updated
2026-04-02

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

ProbioticPlacebo

Probiotic: The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8, week 12)

Placebo: The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8, week 12)

Study summary

To evaluate the impact of pasteurized Akkermansia muciniphila Akk11 capsules versus placebo on body composition (including body weight, BMI, body fat percentage, waist-to-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate) and serum lipid parameters (TC, LDL-C, HDL-C, and TG) in overweight and obese adults.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Body mass index (BMI) ≥ 24 kg/m²; 2. Able and willing to provide written informed consent; 3. Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet; 4. No intention to conceive from 14 days prior to screening until 6 months after study completion, and agreement to use effective contraception during this period Exclusion Criteria: 1. Recent use of products with similar functions to the investigational product that may interfere with study outcomes; 2. History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies; 3. Pregnant or breastfeeding women, or those planning to become pregnant during the study period; 4. Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus; 5. Use of antibiotics within 3 months prior to screening; 6. Inability to comply with the study protocol, including failure to take the investigational product as required or attend scheduled follow-up visits; 7. Smoking more than 10 cigarettes per day; 8. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Primary outcome measure(s)

  • Change from baseline in body weight following the intervention — Baseline (Week 0) and Weeks 4, 8, and 12
    Body weight will be assessed using a calibrated digital scale under standardized conditions

Trial sites (1)

FacilityCityRegionStatus
The School of Food and Bioengineering, Henan University of Science and Technolog Luoyang Henan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07507929 on ClinicalTrials.gov ↗ ← All trials in China