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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02215694
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Dietary Supplement: dual probiotics Dietary Supplement: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Experimental: probiotic group
consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
Dietary Supplement: dual probiotics
2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
Other Name: probiotic

Placebo Comparator: placebo group
consumed 2g of powder daily without probiotics
Dietary Supplement: placebo
2g of powder daily without probiotics




Primary Outcome Measures :
  1. ApoA5-1131 genotype [ Time Frame: at baseline ]
    ApoA5-1131 T>C


Secondary Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215694


Locations
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Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Jong Ho Lee, PhD Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02215694    
Other Study ID Numbers: probiotics_140801
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Yonsei University:
Apolipoprotein A-V
LDL particle size
probiotic
triglyceride
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases