Using probiotics to manage obesity
Efficacy and Safety of Pasteurized Akkermansia Muciniphila Akk11 in Obesity/Overweight Weight Management and Energy Metabolism:a Randomized, Double-blind, Placebo-controlled Trial
This study is testing if taking a specific probiotic can help overweight or obese adults lose weight and improve their cholesterol while they follow a low-carb diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Wecare Probiotics Co., Ltd. Industry-sponsored |
| Locations | 1 site (Luoyang, He Nan) |
| Trial ID | NCT06964932 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of pasteurized Akkermansia muciniphila Akk11 capsules compared to a placebo on various body composition parameters and blood lipid levels in overweight or obese adults. Participants will adhere to a calorie-restricted low-carbohydrate diet while taking the probiotic or placebo. The study aims to determine if this specific probiotic can lead to significant improvements in weight, body fat percentage, and cholesterol levels.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults with a BMI of 25 kg/m² or above who are willing to follow a specific diet and comply with study protocols.
Not a fit: Patients with certain gastrointestinal disorders, those who are pregnant or breastfeeding, or individuals with recent antibiotic use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention for weight management and metabolic health.
How similar studies have performed: While the use of probiotics in obesity management is an emerging field, this specific approach with Akkermansia muciniphila is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A body mass index (BMI) of 25 kg/m² or above; 2. Voluntarily signing an informed consent form to take part in the study; 3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet; 4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes. Exclusion Criteria: 1. Intake of products akin to the test product in the recent period that might sway the outcomes; 2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions; 3. Being pregnant, breastfeeding, or planning to conceive; 4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus; 5. Use of antibiotics in the preceding three months; 6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible; 7. Smoking in excess of 10 cigarettes daily; 8. Hypersensitivity to probiotic products; 9. Any other participants deemed unsuitable for the research by the investigator.
Where this trial is running
Luoyang, He Nan
- The School of Food and Bioengineering, Henan University of Science and Technolog — Luoyang, He Nan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.