Skip to main content
OpenTrials
Completed

NCT Number: NCT06653101

Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects

To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fei Xu

Zhengzhou, None Selected, 210095, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-45 years old;
  • BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
  • Normal liver function indexes;
  • Willing to complete study-related questionnaires and diaries and complete all clinical visits.

Exclusion criteria

  • Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
  • Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
  • Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
  • Recently treated with antibiotics (i.e., < 3 months prior to the start of the study);
  • Participants who smoked more than 10 cigarettes per day were excluded;
  • It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
  • Pregnant and lactating women are not suitable for experiments.

Treatment and study plan

Probiotic

Dietary Supplement

The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)

Placebo

Dietary Supplement

The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)

Primary outcomes

  1. Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.

    Time frame: week 0 and week 8

    Detected by enzyme-linked immunosorbent assay (ELISA).

  2. Changes in serum concentrations of leptin before and after intervention.

    Time frame: week 0 and week 8

    Detected by enzyme-linked immunosorbent assay (ELISA).

  3. Changes in serum concentrations of peptide YY before and after intervention.

    Time frame: week 0 and week 8

    Detected by enzyme-linked immunosorbent assay (ELISA).

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects: a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Nov 18, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.