Research on Probiotics in Improving Obesity

Wecare Probiotics Co., Ltd.61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obesity

Interventions

ProbioticDIETARY_SUPPLEMENT

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

PlaceboDIETARY_SUPPLEMENT

The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8， week 12)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. A body mass index (BMI) of ≥24 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.

Locations (1)

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, China