Probiotic Influence on Obesity-Related Lipidemia

Wecare Probiotics

Status: Completed

Conditions: Overweight or Obesity

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06305650

WK2024001

Details and patient eligibility

About

This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.

Enrollment: 72 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body mass index (BMI) ≥ 28 kg/m2;
2. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
3. Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
4. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;

Exclusion criteria

1. Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
2. Patients with severe allergies and immune deficiency;
3. Women who are pregnant, breastfeeding or planning to become pregnant;
4. Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
5. People who have used antibiotics in the past two weeks;
6. Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;
7. Have used laxatives or fiber supplements in the past 6 weeks;
8. Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

one bag/day BBr60, before meals

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Maltodextrin, one bag/day, before meals

Treatment:

Dietary Supplement: Probiotic