NCT06140641

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.

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 Nov 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 29, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

July 22, 2026

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

September 7, 2023

Last Update Submit

July 21, 2026

Conditions

Overweight/Obese Adults

Outcome Measures

Primary Outcomes (1)

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

    Take stool for microbial community sequencing

    0, 4 and 8 week

Secondary Outcomes (1)

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

    0, 4 and 8 week

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Daily administration of placebo for 8 weeks.

Dietary Supplement: Probiotics

Probiotics group

EXPERIMENTAL

Daily administration of Bifidobacterium Longum BL21 for 8 weeks.

Dietary Supplement: Probiotics

Interventions

ProbioticsDIETARY_SUPPLEMENT

Bifidobacterium Longum BL21 or placebo for 8 weeks.

Also known as: Placebo
Placebo groupProbiotics group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital

Jinnan, Shandong, 250012, China

Location

Related Publications (1)

  • Wang X, Xing Z, Wang R, Zhang G, Liu G, Li Z, Li L. Multi-omics analyses the effect of Bifidobacterium longum subsp. longum BL21 supplementation on overweight and obese subjects: a randomized, double-blind, placebo-controlled study. Nutr Metab (Lond). 2025 Jul 17;22(1):79. doi: 10.1186/s12986-025-00969-2.

    PMID: 40676704DERIVED

MeSH Terms

Conditions

Overweight

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 Officials

  • Tao Zhou, MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2023

First Posted

November 20, 2023

Study Start

November 29, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

July 22, 2026

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)