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

Shandong University

Status: Not yet enrolling

Conditions: Overweight/Obese Adults

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06140641

KYLL-202307-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Daily administration of placebo for 8 weeks.

Treatment:

Dietary Supplement: Probiotics

Probiotics group

Experimental group

Description:

Daily administration of Bifidobacterium Longum BL21 for 8 weeks.

Treatment:

Dietary Supplement: Probiotics