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

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06140641
Collaborator
(none)
72
Enrollment
2
Arms
9.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotics
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Aug 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo group

Daily administration of placebo for 8 weeks.

Dietary Supplement: Probiotics
Bifidobacterium Longum BL21 or placebo for 8 weeks.
Other Names:
  • Placebo

    		•
    Experimental: Probiotics group

    Daily administration of Bifidobacterium Longum BL21 for 8 weeks.

    Dietary Supplement: Probiotics
    Bifidobacterium Longum BL21 or placebo for 8 weeks.
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults [0, 4 and 8 week]

      Take stool for microbial community sequencing

    Secondary Outcome Measures

    1. Effects of intervention with Bifidobacterium longum BL21 on the BMI in overweight/obese adults. [0, 4 and 8 week]

      Record BMI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Body mass index (BMI) ≥ 24kg/m2 indicates overweight, and BMI ≥ 28kg/m2 indicates obesity;

    2. Willing to take the test formulation daily during the study period;

    3. Subjects who understand clinical research and commit to complying with research requirements and procedures.

    Exclusion Criteria:

    1. 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;

    2. Patients with severe allergies and immune deficiencies;

    3. Pregnant, breastfeeding, or expectant women during the study period

    4. Patients with a clear history of gastrointestinal diseases (ulcers, irritable bowel syndrome, etc.);

    5. Have a history of intervention with lipid-lowering drugs or health products within the past 2 months;

    6. Individuals who have used antibiotics within the past two weeks;

    7. Failure to consume the test sample as required, or failure to follow up on time, resulting in uncertain efficacy

    8. Subjects deemed unsuitable by other researchers to participate.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qilu Hospital of Shandong University

    Investigators

    • Principal Investigator: Tao Zhou, MD, Qilu Hospital of Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qilu Hospital of Shandong University
    ClinicalTrials.gov Identifier:
    NCT06140641
    Other Study ID Numbers:
    • KYLL-202307-007
    First Posted:
    Nov 20, 2023
    Last Update Posted:
    Nov 20, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Overweight

    Study Results

    No Results Posted as of Nov 20, 2023