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

NCT ID: NCT06653101

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2025-03-20

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.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Each Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day.

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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 group

Each placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Probiotic

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fei Xu

Zhengzhou, None Selected, China

Countries

China

Other Identifiers

WK2024014

Identifier Type: -

Identifier Source: org_study_id