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

Study Overview
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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.

Official Title
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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

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Dietary Supplement: dual probiotics
* Dietary Supplement: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic group<br>consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032) | Dietary Supplement: dual probiotics<br>* 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)<br>* Other names: probiotic;|
| Placebo Comparator: placebo group<br>consumed 2g of powder daily without probiotics | Dietary Supplement: placebo<br>* 2g of powder daily without probiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoA5-1131 genotype | ApoA5-1131 T>C | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose at baseline and 12-week follow-up | Serum fasting glucose (mg/dL) | 12-week follow-up | 
| Insulin at baseline and 12-week follow-up | Serum insulin (μIU/dL) | 12-week follow-up | 
| C-peptide at baseline and 12-week follow-up | Serum C-peptide (μEq/L) | 12-week follow-up | 
| Apolipoprotein A-V at baseline and 12-week follow-up | Plasma apolipoprotein A-V (ng/mL) | 12-week follow-up | 
| Triglyceride at baseline and 12-week follow-up | Serum triglyceride (mg/dL) | 12-week follow-up | 
| Free fatty acid at baseline and 12-week follow-up | Serum free fatty acid (μEq/L) | 12-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apolipoprotein A-V, LDL particle size, probiotic, triglyceride