Clinical trial NCT02215694: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Keywords: Apolipoprotein A-V
LDL particle size
probiotic
triglyceride
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 128
Sex: ALL
Minimum age (years): 24
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: ApoA5-1131 genotype
timeFrame: at baseline
Secondary outcomes:
measure: Fasting glucose at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Insulin at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: C-peptide at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Apolipoprotein A-V at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Triglyceride at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Free fatty acid at baseline and 12-week follow-up
timeFrame: 12-week follow-up
Other outcomes:
measure: LDL particle size at baseline and 12-week follow-up
timeFrame: 12-week follow-up
measure: Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up
timeFrame: 12-week follow-up
Locations:
city: Seoul
country: Korea, Republic of
facility: Laboratory of Clinical Nutrigenetics/Nutrigenomics
Study officials:
affiliation: Yonsei University
name: Jong Ho Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.