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

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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

Tracking Information
First Submitted Date  ICMJE August 2, 2014
First Posted Date  ICMJE August 13, 2014
Last Update Posted Date August 13, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
ApoA5-1131 genotype [ Time Frame: at baseline ]
ApoA5-1131 T>C
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2014)
  • Fasting glucose at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Serum fasting glucose (mg/dL)
  • Insulin at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Serum insulin (μIU/dL)
  • C-peptide at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Serum C-peptide (μEq/L)
  • Apolipoprotein A-V at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Plasma apolipoprotein A-V (ng/mL)
  • Triglyceride at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Serum triglyceride (mg/dL)
  • Free fatty acid at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Serum free fatty acid (μEq/L)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 11, 2014)
  • LDL particle size at baseline and 12-week follow-up [ Time Frame: 12-week follow-up ]
    Plasma LDL particle size (nm)
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE
  • Dietary Supplement: dual probiotics
    2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
    Other Name: probiotic
  • Dietary Supplement: placebo
    2g of powder daily without probiotics
Study Arms  ICMJE
  • Experimental: probiotic group
    consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
    Intervention: Dietary Supplement: dual probiotics
  • Placebo Comparator: placebo group
    consumed 2g of powder daily without probiotics
    Intervention: Dietary Supplement: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2014)
128
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02215694
Other Study ID Numbers  ICMJE probiotics_140801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong Ho Lee, PhD Yonsei University
PRS Account Yonsei University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP