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

Phase 3

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Dietary Supplement: dual probiotics; Dietary Supplement: placebo

• 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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic group	dual probiotics	consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
placebo group	placebo	consumed 2g of powder daily without probiotics

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Free fatty acid at baseline and 12-week follow-up	12-week follow-up	Serum free fatty acid (μEq/L)
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)
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