Research on Probiotics in Improving Obesity

Wecare Probiotics

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06964919

WK20250421

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Pasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Placebo capsule, one capsules/day

Treatment:

Dietary Supplement: Placebo