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NCT Number: NCT07507929

Probiotic for Weight Management in Overweight and Obese Adults

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, 471000, China

Location contact

Ying Wu, doctor

CONTACT

[email protected]

18639283502 ext. +86

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Change from baseline in body weight following the intervention

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

    Body weight will be assessed using a calibrated digital scale under standardized conditions

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Wu, doctor

CONTACT

[email protected]

18639283502

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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