Research on Probiotics in Improving Obesity

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT06964919
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-22
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study Start: 2025-05-10
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in visceral fat area before and after intervention.	Week 0 , Week 4, Week 8, Week 12	Measured using bioelectrical impedance analysis (BIA)
Change in basal metabolic rate (BMR) before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using indirect calorimetry
Change in serum total cholesterol (TC) concentration before and after intervention	Week 0 and Week 12	Detected by enzyme-linked immunosorbent assay (ELISA)
Change in low-density lipoprotein (LDL) concentration before and after intervention	Week 0 and Week 12	Detected by enzyme-linked immunosorbent assay (ELISA)
Change in high-density lipoprotein (HDL) concentration before and after intervention	Week 0 and Week 12	Detected by enzyme-linked immunosorbent assay (ELISA)
Change in triglyceride (TG) concentration before and after intervention.	Week 0 and Week 12	Detected by enzyme-linked immunosorbent assay (ELISA)
Change in body weight before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using a calibrated scale
Change in BMI before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using a calibrated scale and stadiometer
Change in waist-hip ratio (WC) before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using a non-elastic measuring tape
Change in wrist circumference before and after intervention	Week 0 , Week 4, Week 8, Week 12	Measured using a non-elastic measuring tape

Trial Locations

Locations (1)

The School of Food and Bioengineering, Henan University of Science and Technolog; 🇨🇳 Luoyang, He Nan, China