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OpenTrials
Completed

NCT Number: NCT06964919

Research on Probiotics in Improving Obesity

Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/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;
  • Willingness to provide written informed consent to participate in the study;
  • Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;
  • No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.

Exclusion criteria

  • Use of products similar to the test product in the near term that may affect the results;
  • Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;
  • Pregnant, breastfeeding, or planning pregnancy;
  • Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
  • Antibiotic use within the past three months;
  • Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible;
  • Smoking more than 10 cigarettes a day;
  • Allergy to probiotic products;
  • Other participants deemed unsuitable for the study by the investigator.

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 in body weight before and after intervention

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

    Measured using a calibrated scale

  2. Change in BMI before and after intervention

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

    Measured using a calibrated scale and stadiometer

  3. Change in waist-hip ratio (WC) before and after intervention

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

    Measured using a non-elastic measuring tape

  4. Change in wrist circumference before and after intervention

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

    Measured using a non-elastic measuring tape

  5. Change in visceral fat area before and after intervention.

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

    Measured using bioelectrical impedance analysis (BIA)

  6. Change in basal metabolic rate (BMR) before and after intervention

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

    Measured using indirect calorimetry

  7. Change in serum total cholesterol (TC) concentration before and after intervention

    Time frame: Week 0 and Week 12

    Detected by enzyme-linked immunosorbent assay (ELISA)

  8. Change in low-density lipoprotein (LDL) concentration before and after intervention

    Time frame: Week 0 and Week 12

    Detected by enzyme-linked immunosorbent assay (ELISA)

  9. Change in high-density lipoprotein (HDL) concentration before and after intervention

    Time frame: Week 0 and Week 12

    Detected by enzyme-linked immunosorbent assay (ELISA)

  10. Change in triglyceride (TG) concentration before and after intervention.

    Time frame: Week 0 and Week 12

    Detected by enzyme-linked immunosorbent assay (ELISA)

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: 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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