Probiotic for Weight Management in Overweight and Obese Adults

NCT07507929 — Not applicable, Not yet recruiting, 76 participants, Wecare Probiotics Co., Ltd.

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Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 (34B) on Weight and Energy Metabolism in Overweight and Obese Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Registry	NCT07507929
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	76 (Estimated)
Sponsor	Wecare Probiotics Co., Ltd. (Industry)
Conditions	Obesity
Interventions	Probiotic, Placebo (Dietary supplement)
Dates	start 2026-03-20 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-30 (estimated), first posted 2026-04-02, last updated 2026-04-02
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic group	Experimental	Dietary Supplement: Probiotic	Pasteurized Akkermansia muciniphila Akk11 capsule, 34 billion TFU/day
Placebo group	Placebo comparator	Dietary Supplement: Placebo	Placebo capsule, one capsules/day

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
The School of Food and Bioengineering, Henan University of Science and Technolog	Luoyang, Henan	China