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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02215694
Enrollment
128
Registered
2014-08-13
Start date
2012-06-30
Completion date
2014-03-31
Last updated
2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTplacebo

2g of powder daily without probiotics

DIETARY_SUPPLEMENTdual probiotics

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
24 Years to 68 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ApoA5-1131 genotypeat baselineApoA5-1131 T\>C

Secondary

MeasureTime frameDescription
Fasting glucose at baseline and 12-week follow-up12-week follow-upSerum fasting glucose (mg/dL)
Insulin at baseline and 12-week follow-up12-week follow-upSerum insulin (μIU/dL)
C-peptide at baseline and 12-week follow-up12-week follow-upSerum C-peptide (μEq/L)
Triglyceride at baseline and 12-week follow-up12-week follow-upSerum triglyceride (mg/dL)
Free fatty acid at baseline and 12-week follow-up12-week follow-upSerum free fatty acid (μEq/L)
Apolipoprotein A-V at baseline and 12-week follow-up12-week follow-upPlasma apolipoprotein A-V (ng/mL)

Other

MeasureTime frameDescription
LDL particle size at baseline and 12-week follow-up12-week follow-upPlasma LDL particle size (nm)
Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up12-week follow-upSerum high-sensitivity C-reactive protein (mg/dL)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026