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

• ClinicalTrials.gov Identifier: NCT02215694
• Recruitment Status: Completed
• First Posted: August 13, 2014
• Last Update Posted: August 13, 2014
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: August 2, 2014
• First Posted Date: August 13, 2014
• Last Update Posted Date: August 13, 2014
• Study Start Date: June 2012
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2014)

ApoA5-1131 genotype [ Time Frame: at baseline ]

ApoA5-1131 T>C

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: 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: Supplementation of Dual Probiotic Strains Reduced Fasting Triglyceride and Enhanced Apolipoprotein A-V Levels
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Hypertriglyceridemia

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2014): 128
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 24 Years to 68 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02215694
• Other Study ID Numbers: probiotics_140801
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jong Ho Lee, PhD; Yonsei University

• PRS Account: Yonsei University
• Verification Date: August 2014