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

Overweight Clinical Trial

Official title:

Effect of Weizmania Coagulans BC99 Intervention on Gut Microbiota and Metabolic Markers in Overweight Adults: Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06077383
• Other study ID #: QLYY-202307-008
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: September 2023
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

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.

Related Conditions & MeSH terms

• Overweight

Intervention

Dietary Supplement:
• Weizmania Coagulans BC99
Probiotics group subjects take probiotics every day for 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The gut microbiota were sequenced by 16s high-throughput sequencing.	Verification of the effects of Weizmania Coagulans BC99 on the gut microbiota in overweight adult subjects.	0, 4 and 8 week
Secondary	The fat related biomarkers (TG, TC, HDL, LDL) were detected by blood biochemistry.	Verification of the effects of Weizmania Coagulans BC99 on the fat related biomarkers (TG, TC, HDL, LDL) in overweight adult subjects.	0, 4 and 8 week