Not Yet RecruitingNot Applicable

Probiotic for Weight Management in Overweight and Obese Adults

China76 participantsStarted 2026-03-20

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Body mass index (BMI) ≥ 24 kg/m²;
✓. Able and willing to provide written informed consent;
✓. Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet;
✓. 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

✕. Recent use of products with similar functions to the investigational product that may interfere with study outcomes;
✕. History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies;
✕. Pregnant or breastfeeding women, or those planning to become pregnant during the study period;
✕. Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus;
✕. Use of antibiotics within 3 months prior to screening;
✕. Inability to comply with the study protocol, including failure to take the investigational product as required or attend scheduled follow-up visits;
✕. Smoking more than 10 cigarettes per day;
✕. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

What they're measuring

Change from baseline in body weight following the intervention

Timeframe: Baseline (Week 0) and Weeks 4, 8, and 12

Trial details

NCT IDNCT07507929

SponsorWecare Probiotics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Ying Wu, doctor

18639283502 yingwu@haust.edu.cn

View on ClinicalTrials.gov More Obesity trials