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

Supplementation of Dual Probiotic Strains, Lactobacillus Curvatus HY7601 and Lactobacillus Plantarum KY1032, Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels in Nondiabetic and Hypertriglyceridemic Subjects

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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: dual probiotics; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-749
    • Laboratory of Clinical Nutrigenetics/Nutrigenomics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 68 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: probiotic group; consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)	Dietary supplement: dual probiotics; 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032); Other Names: probiotic
PLACEBO_COMPARATOR: placebo group; consumed 2g of powder daily without probiotics	Dietary supplement: placebo; 2g of powder daily without probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ApoA5-1131 genotype	ApoA5-1131 T>C	at baseline

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL particle size at baseline and 12-week follow-up	Plasma LDL particle size (nm)	12-week follow-up
Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up	Serum high-sensitivity C-reactive protein (mg/dL)	12-week follow-up

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Ahn HY, Kim M, Ahn YT, Sim JH, Choi ID, Lee SH, Lee JH. The triglyceride-lowering effect of supplementation with dual probiotic strains, Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032: Reduction of fasting plasma lysophosphatidylcholines in nondiabetic and hypertriglyceridemic subjects. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):724-33. doi: 10.1016/j.numecd.2015.05.002. Epub 2015 May 14.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: August 2, 2014
• First Submitted That Met QC Criteria: August 11, 2014
• First Posted (ESTIMATE): August 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 13, 2014
• Last Update Submitted That Met QC Criteria: August 11, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: probiotic; triglyceride; Apolipoprotein A-V; LDL particle size
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: probiotics_140801