Probiotic for Weight Management in Overweight and Obese Adults

Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 (34B) on Weight and Energy Metabolism in Overweight and Obese Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

To evaluate the impact of pasteurized Akkermansia muciniphila Akk11 capsules versus placebo on body composition (including body weight, BMI, body fat percentage, waist-to-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate) and serum lipid parameters (TC, LDL-C, HDL-C, and TG) in overweight and obese adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Wu, doctor; Phone Number: 18639283502; Email: yingwu@haust.edu.cn

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • The School of Food and Bioengineering, Henan University of Science and Technolog
      • Contact: Ying Wu, doctor; Phone Number: +86 18639283502; Email: yingwu@haust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Body mass index (BMI) ≥ 24 kg/m²;
2. Able and willing to provide written informed consent;
3. Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet;
4. No intention to conceive from 14 days prior to screening until 6 months after study completion, and agreement to use effective contraception during this period

Exclusion Criteria:

1. Recent use of products with similar functions to the investigational product that may interfere with study outcomes;
2. History of psychiatric or neurological disorders, celiac disease, lactose intolerance, or known allergies;
3. Pregnant or breastfeeding women, or those planning to become pregnant during the study period;
4. Diagnosis of irritable bowel syndrome (IBS), ulcerative colitis, liver cirrhosis, or diabetes mellitus;
5. Use of antibiotics within 3 months prior to screening;
6. Inability to comply with the study protocol, including failure to take the investigational product as required or attend scheduled follow-up visits;
7. Smoking more than 10 cigarettes per day;
8. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Placebo capsule, one capsules/day	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)
Experimental: Probiotic group; Pasteurized Akkermansia muciniphila Akk11 capsule, 34 billion TFU/day	Dietary supplement: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in body weight following the intervention	Body weight will be assessed using a calibrated digital scale under standardized conditions	Baseline (Week 0) and Weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Probiotics
• Other Study ID Numbers: WK20260327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No