NCT06305650Completed
Probiotic Influence on Obesity-Related Lipidemia
The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 5 Mar 2024
- Start date
- 20 Mar 2024
- Primary completion date
- 20 Jun 2024
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT06305650
What you commit to
- Study type: Interventional
- Participants enrolled: 72
- From 20 Mar 2024 to the primary completion date, 20 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with severe allergies and immune deficiency;
- Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
- Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.
Other
- Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
- Women who are pregnant, breastfeeding or planning to become pregnant;
- 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;
Who the study is looking for
- 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;
Age in the registry: 19 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.