Clinical trial NCT06964919: Research on Probiotics in Improving Obesity
Official title: Effectiveness and Safety of Inactivated Akkermansia Muciniphila Akk11 for Weight and Energy Metabolism in Obesity/Overweight: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.


Eligibility 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.

Primary outcomes:
measure: Change in body weight before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in BMI before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in waist-hip ratio (WC) before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in wrist circumference before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in visceral fat area before and after intervention.
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in basal metabolic rate (BMR) before and after intervention
timeFrame: Week 0 , Week 4, Week 8, Week 12
measure: Change in serum total cholesterol (TC) concentration before and after intervention
timeFrame: Week 0 and Week 12
measure: Change in low-density lipoprotein (LDL) concentration before and after intervention
timeFrame: Week 0 and Week 12
measure: Change in high-density lipoprotein (HDL) concentration before and after intervention
timeFrame: Week 0 and Week 12
measure: Change in triglyceride (TG) concentration before and after intervention.
timeFrame: Week 0 and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: The School of Food and Bioengineering, Henan University of Science and Technolog
state: He Nan
Study officials:
References: