Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels

Phase 3

Completed

• Conditions: Hypertriglyceridemia

• Registration Number: NCT02215694
• Lead Sponsor: Yonsei University

Brief Summary

The purpose of this study is to evaluate the effect of dual probiotic strains containing Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032 on triglyceride and apolipoprotein A-V.

Detailed Description

A randomized, double-blind, placebo-controlled study was conducted on 128 nondiabetic and hypertriglyceridemic (Plasma Triglyceride, 150-500 mg/dL) subjects. Over a 12 week test period, the probiotic group consumed 2g of powder daily containing dual probiotic strains, while the placebo group consumed the same without probiotics.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Study First Submitted: 2014-08-02
• Study First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• nondiabetic (plasma fasting glucose, <126mg/dL; 2-hour plasma glucose, <200mg/dL)
• borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)

Exclusion Criteria

• lipid-lowering medications use
• any medications or supplement use
• any probiotics products use for the past 1 months
• dyslipidemia
• diabetes mellitus
• hypertension
• liver disease
• renal disease
• cardiovascular disease
• cerebrovascular disease
• pancreatitis
• cancer
• medication or alcohol abuse
• pregnant or breast feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ApoA5-1131 genotype	at baseline	ApoA5-1131 T\>C

Secondary Outcome Measures

Name	Time	Method
Fasting glucose at baseline and 12-week follow-up	12-week follow-up	Serum fasting glucose (mg/dL)
Apolipoprotein A-V at baseline and 12-week follow-up	12-week follow-up	Plasma apolipoprotein A-V (ng/mL)
C-peptide at baseline and 12-week follow-up	12-week follow-up	Serum C-peptide (μEq/L)
Free fatty acid at baseline and 12-week follow-up	12-week follow-up	Serum free fatty acid (μEq/L)
Insulin at baseline and 12-week follow-up	12-week follow-up	Serum insulin (μIU/dL)
Triglyceride at baseline and 12-week follow-up	12-week follow-up	Serum triglyceride (mg/dL)

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics; 🇰🇷 Seoul, Korea, Republic of