NCT06305650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

March 5, 2024

Last Update Submit

September 11, 2024

Conditions

Overweight or Obesity

Keywords

ProbioticObesity

Outcome Measures

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).

    12 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

one bag/day BBr60, before meals

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Maltodextrin, one bag/day, before meals

Dietary Supplement: Probiotic

Interventions

ProbioticDIETARY_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 groupProbiotic group

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Double（Participant,Investigator）
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 20, 2024

Primary Completion

June 20, 2024

Study Completion

July 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)