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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215694
• Other study ID #: probiotics_140801
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2014
• Last updated: August 11, 2014
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Dietary Supplement:
• dual probiotics
2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
• placebo
2g of powder daily without probiotics

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	LDL particle size at baseline and 12-week follow-up	Plasma LDL particle size (nm)	12-week follow-up	Yes
Other	Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up	Serum high-sensitivity C-reactive protein (mg/dL)	12-week follow-up	Yes
Primary	ApoA5-1131 genotype	ApoA5-1131 T>C	at baseline	Yes
Secondary	Fasting glucose at baseline and 12-week follow-up	Serum fasting glucose (mg/dL)	12-week follow-up	Yes
Secondary	Insulin at baseline and 12-week follow-up	Serum insulin (µIU/dL)	12-week follow-up	Yes
Secondary	C-peptide at baseline and 12-week follow-up	Serum C-peptide (µEq/L)	12-week follow-up	Yes
Secondary	Apolipoprotein A-V at baseline and 12-week follow-up	Plasma apolipoprotein A-V (ng/mL)	12-week follow-up	Yes
Secondary	Triglyceride at baseline and 12-week follow-up	Serum triglyceride (mg/dL)	12-week follow-up	Yes
Secondary	Free fatty acid at baseline and 12-week follow-up	Serum free fatty acid (µEq/L)	12-week follow-up	Yes