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

Not Applicable

Completed

• Conditions: Overweight or Obesity

• Registration Number: NCT06653101
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-18
• Study Start: 2024-10-20
• Study First Posted: 2024-10-22
• Status Verified: 2024-12
• Primary Completion: 2024-12-05
• Study Completion: 2025-03-20
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. 18-45 years old;
2. BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
3. Normal liver function indexes;
4. Willing to complete study-related questionnaires and diaries and complete all clinical visits.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.	week 0 and week 8	Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of leptin before and after intervention.	week 0 and week 8	Detected by enzyme-linked immunosorbent assay (ELISA).
Changes in serum concentrations of peptide YY before and after intervention.	week 0 and week 8	Detected by enzyme-linked immunosorbent assay (ELISA).

Trial Locations

Locations (1)

Fei Xu; 🇨🇳 Zhengzhou, None Selected, China