Efficacy of probiotic food supplement in human volunteers with risk factors of metabolic syndrome

Phase 3

Completed

• Conditions: Risk of metabolic syndrome patients such as HbA1c 5.7%-6.4%, LDL more than 130 mg/dl, triglyceride more than 150 mg/dl, BMI more than 23; Probiotic; Bifidobacterium animalis TA1 Lactobacillus reuteri TF7; Metabolic syndrome

• Registration Number: TCTR20220621002
• Lead Sponsor: CPF Food Research and Development Center Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-31
• Study Start: 2022-06-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age 18-60 years both men and women
2. HbA1c 5.7%-6.4%
3. LDL more than 130 mg/dl
4. Triglyceride more than 150 mg/dl
5. BMI more than 23

Exclusion Criteria

1. Underlying diseases of diabetes, hypertension, chronic kidney disease, any cancers, immunodeficiency
2. Current taking lipid-lowering drugs
3. Current taking antibiotics
4. Smoking
5. Allergic to probiotics
6. Pregnancy and breastfeeding
7. Alcohol addicted

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cholesterol (LDL ) follow up every 4 week for 12 weeks Blood level of LD

Secondary Outcome Measures

Name	Time	Method
Triglyceride follow up every 4 week for 12 weeks Blood level for triglyceride,HbA1c follow up every 4 week for 12 weeks Blood level for HbA1c,BMI (kg/m2 ) follow up every 4 week for 12 weeks BMI (kg/m2 ),Body Weight (kg) follow up every 4 week for 12 weeks Body Weight (kg) ,Gut microbiome At week 12 Stool examination