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OpenTrials
Completed

NCT Number: NCT06964932

Probiotics in Obesity Management

Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A body mass index (BMI) of 24 kg/m² or above;
  • Voluntarily signing an informed consent form to take part in the study;
  • Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
  • No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.

Exclusion criteria

  • Intake of products akin to the test product in the recent period that might sway the outcomes;
  • Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
  • Being pregnant, breastfeeding, or planning to conceive;
  • Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
  • Use of antibiotics in the preceding three months;
  • Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
  • Smoking in excess of 10 cigarettes daily;
  • Hypersensitivity to probiotic products;
  • Any other participants deemed unsuitable for the research by the investigator.

Treatment and study plan

Probiotc

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 in body weight before and after intervention

    Time frame: Week 0 , Week 4, Week 8, Week 12

    Measured using a calibrated scale

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Efficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 11, 2025
Registry last updated
Jan 29, 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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