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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

Korea, Republic of

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, Korea, Republic of, 120-749

Sponsors and Collaborators

Yonsei University

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02215694
• Other Study ID Numbers: probiotics_140801
• First Posted: August 13, 2014
• 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:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases