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

Primary Purpose

Hypertriglyceridemia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

dual probiotics

placebo

About this trial

This is an interventional basic science trial for Hypertriglyceridemia focused on measuring Apolipoprotein A-V, LDL particle size, probiotic, triglyceride

Eligibility Criteria

24 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotic group

placebo group

Arm Description

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

consumed 2g of powder daily without probiotics

Outcomes

Primary Outcome Measures

ApoA5-1131 genotype

ApoA5-1131 T>C

Secondary Outcome Measures

Fasting glucose at baseline and 12-week follow-up

Serum fasting glucose (mg/dL)

Insulin at baseline and 12-week follow-up

Serum insulin (μIU/dL)

C-peptide at baseline and 12-week follow-up

Serum C-peptide (μEq/L)

Apolipoprotein A-V at baseline and 12-week follow-up

Plasma apolipoprotein A-V (ng/mL)

Triglyceride at baseline and 12-week follow-up

Serum triglyceride (mg/dL)

Free fatty acid at baseline and 12-week follow-up

Serum free fatty acid (μEq/L)

Full Information

NCT ID

NCT02215694

First Posted

August 2, 2014

Last Updated

August 11, 2014

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02215694

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertriglyceridemia

Keywords

Apolipoprotein A-V, LDL particle size, probiotic, triglyceride

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

probiotic group

Arm Type

Experimental

Arm Description

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

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm Description

consumed 2g of powder daily without probiotics

Intervention Type

Dietary Supplement

Intervention Name(s)

dual probiotics

Other Intervention Name(s)

probiotic

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

2g of powder daily without probiotics

Primary Outcome Measure Information:

Title

ApoA5-1131 genotype

Description

ApoA5-1131 T>C

Time Frame

at baseline

Secondary Outcome Measure Information:

Title

Fasting glucose at baseline and 12-week follow-up

Description

Serum fasting glucose (mg/dL)

Time Frame

12-week follow-up

Title

Insulin at baseline and 12-week follow-up

Description

Serum insulin (μIU/dL)

Time Frame

12-week follow-up

Title

C-peptide at baseline and 12-week follow-up

Description

Serum C-peptide (μEq/L)

Time Frame

12-week follow-up

Title

Apolipoprotein A-V at baseline and 12-week follow-up

Description

Plasma apolipoprotein A-V (ng/mL)

Time Frame

12-week follow-up

Title

Triglyceride at baseline and 12-week follow-up

Description

Serum triglyceride (mg/dL)

Time Frame

12-week follow-up

Title

Free fatty acid at baseline and 12-week follow-up

Description

Serum free fatty acid (μEq/L)

Time Frame

12-week follow-up

Other Pre-specified Outcome Measures:

Title

LDL particle size at baseline and 12-week follow-up

Description

Plasma LDL particle size (nm)

Time Frame

12-week follow-up

Title

Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up

Description

Serum high-sensitivity C-reactive protein (mg/dL)

Time Frame

12-week follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Ho Lee, PhD

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laboratory of Clinical Nutrigenetics/Nutrigenomics

City

Seoul

ZIP/Postal Code

120-749

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

26044516

Citation

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.

Results Reference

derived

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

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