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OpenTrials
Completed

NCT Number: NCT06305650

Probiotic Influence on Obesity-Related Lipidemia

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.

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Key information

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥ 28 kg/m2;
  • Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
  • Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
  • 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

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

Treatment and study plan

Probiotic

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.

Primary outcomes

  1. Effect on body mass index (BMI) values.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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