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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- ApoA5-1131 genotype
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 24 Years to 68 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •medication or alcohol abuse
- •pregnant or breast feeding
Arms & Interventions
probiotic group
consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
Intervention: dual probiotics (Dietary Supplement)
placebo group
consumed 2g of powder daily without probiotics
Intervention: placebo (Dietary Supplement)
Outcomes
Primary Outcomes
ApoA5-1131 genotype
Time Frame: at baseline
ApoA5-1131 T\>C
Secondary Outcomes
- Fasting glucose at baseline and 12-week follow-up(12-week follow-up)
- Apolipoprotein A-V at baseline and 12-week follow-up(12-week follow-up)
- C-peptide at baseline and 12-week follow-up(12-week follow-up)
- Free fatty acid at baseline and 12-week follow-up(12-week follow-up)
- Insulin at baseline and 12-week follow-up(12-week follow-up)
- Triglyceride at baseline and 12-week follow-up(12-week follow-up)