Probiotic Influence on Obesity-Related Lipidemia

NCT ID: NCT06305650

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-07-30

Brief Summary

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.

Conditions

Overweight or Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Probiotic group

one bag/day BBr60, before meals

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Through oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis.

Placebo group

Maltodextrin, one bag/day, before meals

Group Type: PLACEBO_COMPARATOR

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Through oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis.

Interventions

Probiotic

Through oral probiotic intervention for 12 weeks, participants' BMI, body fat percentage, and waist-to-hip ratio will be measured at weeks 0, 6, and 12, and fecal samples will be collected at weeks 0 and 12 for gut microbiota analysis.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan University of Science and Technology

Luoyang, Henan, China

Countries

China

Other Identifiers

WK2024001

Identifier Type: -

Identifier Source: org_study_id