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Completed
NCT06140641
Effects of the Bifidobacterium Longum BL21 on BMI, Metabolic Indicators, and Gut Microbiota in Overweight/Obese Adults
Conditions: Overweight/Obese Adults
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Qilu Hospital of Shandong University
Location: Qilu hospital Jinnan Shandong
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.
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.
Source: ClinicalTrials.gov (NCT06140641). StuddyBuddy aggregates publicly available trial information.