Research on Probiotics in Improving Obesity

NCT ID: NCT06964919

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2026-01-20

Brief Summary

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.

Conditions

Obesity

Study Design

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

Study Groups

Probiotic group

Pasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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 group

Placebo capsule, one capsules/day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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)

Interventions

Probiotic

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. A body mass index (BMI) of ≥24 kg/m²;

2. Willingness to provide written informed consent to participate in the study;

3. Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet;

4. No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception.

Exclusion Criteria

1. Use of products similar to the test product in the near term that may affect the results;

2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies;

3. Pregnant, breastfeeding, or planning pregnancy;

4. Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;

5. Antibiotic use within the past three months;

6. Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible;

7. Smoking more than 10 cigarettes a day;

8. Allergy to probiotic products;

9. Other participants deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, China

Countries

China

Other Identifiers

WK20250421

Identifier Type: -

Identifier Source: org_study_id