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

NCT ID: NCT02215694

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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probiotic group

consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)

Group Type EXPERIMENTAL

dual probiotics

Intervention Type DIETARY_SUPPLEMENT

2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)

placebo group

consumed 2g of powder daily without probiotics

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2g of powder daily without probiotics

Interventions

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dual probiotics

2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)

Intervention Type DIETARY_SUPPLEMENT

placebo

2g of powder daily without probiotics

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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probiotic

Eligibility Criteria

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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
Minimum Eligible Age

24 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jong Ho Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26044516 (View on PubMed)

Other Identifiers

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probiotics_140801

Identifier Type: -

Identifier Source: org_study_id

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