Skip to main content
OpenTrials
Completed

NCT Number: NCT06140641

Effects of the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults.

The blood, urine, and feces samples of the subjects need to be collected at 0,4 and 8 week and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu hospital

Jinnan, Shandong, 250012, China

About this study

The goal of this study is to investigate the effects of Bifidobacterium longum subspecies BL21 on BMI, metabolic indicators, and changes in gut microenvironment microbiota in overweight/obese adults. Randomized grouping was used to provide probiotic BL21 or placebo intervention. The total duration of the study is 8 weeks, including 8 weeks (1-8 weeks) of intervention expectations. The subjects were followed up at weeks 2 and 6, and sampled at weeks 0, 4, and 8. After the intervention during the follow-up period, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, all groups of subjects were required to take the corresponding products daily and record adverse reactions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity;
  • Willing to take the test formulation daily during the study period;
  • Subjects who understand clinical research and commit to complying with research requirements and procedures.

Exclusion criteria

  • Patients with serious chronic diseases (heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental disease and organ surgery history, diabetes, etc.) and complications;
  • Patients with severe allergies and immune deficiencies;
  • Pregnant, breastfeeding, or expectant women during the study period
  • Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.);
  • Have a history of intervention with lipid-lowering drugs or health products within the past 2 months;
  • Individuals who have used antibiotics within the past two weeks;
  • Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy
  • Subjects deemed unsuitable by other researchers to participate.

Treatment and study plan

Probiotics

Dietary Supplement

Bifidobacterium Longum BL21 or placebo for 8 weeks.

Other names: Placebo

Primary outcomes

  1. Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults

    Time frame: 0, 4 and 8 week

    Take stool for microbial community sequencing

Secondary outcomes

  1. Effects of intervention with Bifidobacterium longum BL21 on the BMI in overweight/obese adults.

    Time frame: 0, 4 and 8 week

    Record BMI

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

Effects of Supplementing the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults: a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2023
Registry last updated
Jul 22, 2026

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.

Published trials that share one or more normalized conditions with this study.