Probiotic for Weight Management in Overweight and Obese Adults

NCT07507929 | Not Yet Recruiting

• 1 other identifier: WK20260327
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Probiotic group

EXPERIMENTAL

Pasteurized Akkermansia muciniphila Akk11 capsule, 34 billion TFU/day

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Placebo capsule, one capsules/day

Dietary Supplement: Placebo

Interventions

Probiotic 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:

• Body mass index (BMI) ≥ 24 kg/m²;
• Able and willing to provide written informed consent;
• Willing to comply with the study protocol and required restrictions, including adherence to a low-carbohydrate, energy-restricted diet;
• 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

You may not qualify if:

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

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

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ying Wu, doctor

CONTACT

18639283502; yingwu@haust.edu.cn

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: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)