Clinical trial NCT06140641: Effects of the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight/Obese Adults
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effects of intervention with Bifidobacterium longum BL21 on the gut microbiota in overweight/obese adults
timeFrame: 0, 4 and 8 week
Secondary outcomes:
measure: Effects of intervention with Bifidobacterium longum BL21 on the BMI in overweight/obese adults.
timeFrame: 0, 4 and 8 week
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Tao Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: