Innovative development of probiotic food supplement products and clinical trials for reducing the risk factor of noncommunicable diseases

Phase 3

Completed

• Conditions: Volunteers 18-60 years with LDL more than 130 mg/dl , or triglycerides more than 150 mg/dl , or fasting plasma glucose ranging 100-125 mg/dl; Probiotics, noncommunicable diseases, food supplements,; functional ingredients

• Registration Number: TCTR20230715001
• Lead Sponsor: The Program Management Unit for Competitiveness (PMUC)

Brief Summary

After 12 weeks, Triglycerides, total cholesterol, and LDL-C were significantly reduced in the probiotics group compared with baseline and placebo. Body mass index, body weight, waist, and hip circumference, and systolic blood pressure in the probiotic group significantly decreased compared with the placebo group.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-03-15
• Study Start: 2023-07-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Volunteers 18-60 years with LDL more than 130 mg/dl , or triglycerides more than 150 mg/dl , or fasting plasma glucose ranging 100-125 mg/dl

Exclusion Criteria

Underlying of Diabetes, Hypertension
Cardiovascular diseases
Cancer
Liver diseases
Immunodeficiency
Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DL, Triglycerides, Fasting blood sugar 12 weeks LDL, Triglycerides, Fasting blood sugar (Mg/dl)

Secondary Outcome Measures

Name	Time	Method
Blood test for Triglycerides (mg/dl) 12 weeks Blood test for Triglycerides (mg/dl)