Probiotic for Weight Management in Overweight and Obese Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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) - 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)
Primary outcome measures
- Change from baseline in body weight following the intervention [Time frame: Baseline (Week 0) and Weeks 4, 8, and 12]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The School of Food and Bioengineering, Henan University of Science and Technolog — Luoyang
Identifiers
NCT: NCT07507929 · WK20260327