Using probiotics to improve obesity
Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: a Randomized, Double-blind, Placebo-controlled Trial
This study tests if taking heat-killed Akkermansia muciniphila probiotics can help overweight and obese adults lose weight and improve their cholesterol levels while following 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 | NCT06964919 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of heat-killed Akkermansia muciniphila bacteria capsules on various body composition indicators and blood lipid levels in overweight and obese adults. Participants will be assigned to receive either the probiotic or a placebo while adhering to a low-carbohydrate, energy-restricted diet. The primary outcomes include changes in weight, BMI, body fat percentage, and lipid profiles over the course of the intervention. The study aims to determine if this specific probiotic can effectively aid in weight management and improve metabolic health.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese adults with a BMI of 25 kg/m² or higher who are willing to follow a specific diet and provide informed consent.
Not a fit: Patients with certain gastrointestinal disorders, metabolic diseases, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel probiotic treatment option for managing obesity and improving metabolic health.
How similar studies have performed: While the use of probiotics for weight 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; 2. Willingness to provide written informed consent to participate in the study; 3. Agreement to adhere to the study protocol and restrictions, including a low-carbohydrate, energy-restricted diet; 4. No plans for conception from 14 days before screening until 6 months after the trial, with a commitment to using effective contraception. Exclusion Criteria: 1. Use of products similar to the test product in the near term that may affect the results; 2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergies; 3. Pregnant, breastfeeding, or planning pregnancy; 4. Irritable Bowel Syndrome (IBS), Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus; 5. Antibiotic use within the past three months; 6. Failure to consume the test product as required or attend follow-ups on time, making efficacy assessment impossible; 7. Smoking more than 10 cigarettes a day; 8. Allergy to probiotic products; 9. Other participants deemed unsuitable for the study 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.