Probiotic Influence on Obesity-Related Lipidemia

Not Applicable

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Dietary Supplement: Probiotic

• Registration Number: NCT06305650
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Study Start: 2024-03-20
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-06-20
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probiotic	one bag/day BBr60, before meals
Placebo group	Probiotic	Maltodextrin, one bag/day, before meals

Primary Outcome Measures

Name	Time	Method
Effect on body mass index (BMI) values.	12 weeks	After the probiotic intervention, the change in body mass index (BMI) from baseline in obese/overweight individuals will be calculated. BMI is measured by dividing a person's weight in kilograms by the square of their height in meters (kg/m\^2).

Trial Locations

Locations (1)

Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China