Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight Adults

Not Applicable

Not yet recruiting

• Conditions: Overweight
• Interventions: Dietary Supplement: Weizmania Coagulans BC99

• Registration Number: NCT06077383
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight adult subjects.

The subjects participate were randomly grouped and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks. After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.

Detailed Description

The main purpose of this study is to verify the effects of Weizmania Coagulans BC99 on the gut microbiota and fat related markers (TG, TC, HDL, LDL) in overweight adult subjects.

The subjects participate in the screening on a voluntary basis, and those who pass the screening will enter the trial. Randomly group and receive intervention with Weizmann clotting bacteria BC99 or placebo. The total duration of the study is 8 weeks, including 1 week before the trial (followed up once), 4 weeks during the trial (followed up once a week), and 8 weeks during the trial (followed up once a week). After the intervention, blood, urine, and feces samples of the subjects need to be collected and promptly tested in the laboratory. During the intervention period, each group of subjects was required to take the corresponding product daily and record complications.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-10-08
• Last Update Submitted: 2023-10-08
• Study Start: 2023-10-10
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. All patients meet the diagnostic criteria for severe illness, and a body mass index (BMI) of ≥ 24kg/m2 is considered overweight;
2. Age 18-65 years old;
3. Without dieting or weight loss, and able to accept dietary intervention, maintain a low-carbon and healthy diet during the trial period;
4. Patients who understand clinical research and commit to complying with research requirements and procedures;
5. Patients who have signed informed consent forms. Able to complete research according to the requirements of the experimental protocol;

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Exclusion Criteria

1. Taking items with similar functions to the test subjects in the short term can affect the judgment of the results;
2. Have taken antibiotics 2 weeks before recruitment;
3. Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information;
4. Obesity caused by drug treatment (hormones, antidepressants, etc.), endocrine diseases, combined with severe liver and kidney dysfunction, water retention or muscle development;
5. Patients who are pregnant, lactating, stomatal, critically ill, or have potential health conditions that affect metabolism or weight;
6. Neuroendocrine system diseases (hypothyroidism, polycystic ovary syndrome, Cushing's syndrome, hypothalamic injury, etc.);
7. Have a clear history of gastrointestinal diseases (such as ulcers, gastrointestinal bleeding, irritable bowel syndrome, celiac disease, inflammatory bowel disease, Crohn's disease, or other diseases) and a history of surgery (such as weight loss surgery, bandaging surgery, gastrointestinal anastomosis surgery, and intestinal resection surgery);
8. Hereditary obesity Hereditary obesity (such as PWS, Down's syndrome), metabolic obesity (such as obesity reproductive impotence syndrome), endocrine obesity (such as Kirschner's syndrome, hypothyroidism), any disease affecting liver fibrosis or steatosis, metabolic disease (such as hypothyroidism/hyperthyroidism, type 1 or type 2 diabetes, etc.);
9. Patients who changed their diet type during the study period;
10. Patients with severe diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic systems, as well as endocrine diseases, and mental illnesses;
11. According to the researcher's judgment, the condition of the subject does not qualify them to participate in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics group	Weizmania Coagulans BC99	Probiotics group subjects take probiotics every day for 8 weeks.
Placebo group	Weizmania Coagulans BC99	Placebo group subjects take placebo every day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
The gut microbiota were sequenced by 16s high-throughput sequencing.	0, 4 and 8 week	Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.

Secondary Outcome Measures

Name	Time	Method
The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.	0, 4 and 8 week	Verification of the effects of Weizmania Coagulans BC99 on the fat related biomarkers (TG, TC, HDL, LDL) in overweight adult subjects.