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CompletedNCT06305650Updated Sep 19, 2024

Probiotic Influence on Obesity-Related Lipidemia

An interventional study of Probiotic in Overweight or Obesity, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight or Obesity

Keywords

  • Probiotic
  • Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 72 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Probiotic group

    one bag/day BBr60, before meals

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo group

    Maltodextrin, one bag/day, before meals

    Dietary Supplement: Probiotic

Interventions

  • Dietary supplementProbiotic

    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.

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 12 weeks

07

Study locations

1 site
  • Henan University of Science and Technology
    Luoyang, Henan 471000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06305650
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Mar 20, 2024
Primary completion
Jun 20, 2024
Completion
Jul 30, 2024
Last update
Sep 19, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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