Probiotics in Obesity Management

NCT06964932 | Completed

• 1 other identifier: WK20250424
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight before and after intervention

  Measured using a calibrated scale

  Week 0 , Week 4, Week 8, Week 12

Study Arms (2)

Probiotic group

EXPERIMENTAL

Pasteurized Akkermansia muciniphila Akk11 capsule, 100 billion TFU/day

Dietary Supplement: Probiotc

Placebo group

PLACEBO COMPARATOR

Placebo capsule, one capsule/day

Dietary Supplement: Placebo

Interventions

Probiotc 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)

Probiotic group

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)

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A body mass index (BMI) of 24 kg/m² or above;
• Voluntarily signing an informed consent form to take part in the study;
• Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
• No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.

You may not qualify if:

• Intake of products akin to the test product in the recent period that might sway the outcomes;
• Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
• Being pregnant, breastfeeding, or planning to conceive;
• Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
• Use of antibiotics in the preceding three months;
• Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
• Smoking in excess of 10 cigarettes daily;
• Hypersensitivity to probiotic products;
• Any other participants deemed unsuitable for the research by the investigator.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

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

Luoyang, Henan, 471000, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 11, 2025
• Study Start: March 15, 2025
• Primary Completion: December 3, 2025
• Study Completion: January 28, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (1)