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Completed

NCT Number: NCT02215694

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

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

24 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, 120-749, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dual probiotics

Dietary Supplement

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

Other names: probiotic

Placebo

Dietary Supplement

2g of powder daily without probiotics

Primary outcomes

  1. ApoA5-1131 genotype

    Time frame: at baseline

    ApoA5-1131 T>C

Secondary outcomes

  1. Fasting glucose at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Serum fasting glucose (mg/dL)

  2. Insulin at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Serum insulin (μIU/dL)

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

    Time frame: 12-week follow-up

    Serum C-peptide (μEq/L)

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

    Time frame: 12-week follow-up

    Plasma apolipoprotein A-V (ng/mL)

  5. Triglyceride at baseline and 12-week follow-up

    Time frame: 12-week follow-up

    Serum triglyceride (mg/dL)

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

    Time frame: 12-week follow-up

    Serum free fatty acid (μEq/L)

Other outcomes

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

    Time frame: 12-week follow-up

    Plasma LDL particle size (nm)

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

    Time frame: 12-week follow-up

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2014
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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