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Probiotics in Obesity Management

W

Wecare Probiotics

Status

Enrolling

Conditions

Obesity

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Probiotc

Study type

Interventional

Funder types

Industry

Identifiers

NCT06964932
WK20250424

Details and patient eligibility

About

Evaluate the effects of pasteurized Akkermansia muciniphila Akk11 (killed bacteria) capsules compared to placebo on body composition parameters (including weight, BMI, body fat percentage, waist - hip ratio (WHR), wrist circumference, visceral fat area, and basal metabolic rate) and blood lipid levels (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), and triglycerides (TG)) in overweight or obese adults.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. A body mass index (BMI) of 25 kg/m² or above;
  2. Voluntarily signing an informed consent form to take part in the study;
  3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
  4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.

Exclusion criteria

  1. Intake of products akin to the test product in the recent period that might sway the outcomes;
  2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
  3. Being pregnant, breastfeeding, or planning to conceive;
  4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
  5. Use of antibiotics in the preceding three months;
  6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
  7. Smoking in excess of 10 cigarettes daily;
  8. Hypersensitivity to probiotic products;
  9. Any other participants deemed unsuitable for the research by the investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups, including a placebo group

Probiotic group
Experimental group
Description:
Pasteurized Akkermansia muciniphila Akk11 capsule, 100 billion TFU/day
Treatment:
Dietary Supplement: Probiotc
Placebo group
Placebo Comparator group
Description:
Placebo capsule, one capsules/day
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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