NCT02215694

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

August 2, 2014

Last Update Submit

August 11, 2014

Conditions

Hypertriglyceridemia

Keywords

Apolipoprotein A-VLDL particle sizeprobiotictriglyceride

Outcome Measures

Primary Outcomes (1)

  • ApoA5-1131 genotype

    ApoA5-1131 T\>C

    at baseline

Secondary Outcomes (6)

  • Fasting glucose at baseline and 12-week follow-up

    12-week follow-up

  • Insulin at baseline and 12-week follow-up

    12-week follow-up

  • C-peptide at baseline and 12-week follow-up

    12-week follow-up

  • Apolipoprotein A-V at baseline and 12-week follow-up

    12-week follow-up

  • Triglyceride at baseline and 12-week follow-up

    12-week follow-up

  • +1 more secondary outcomes

Other Outcomes (2)

  • LDL particle size at baseline and 12-week follow-up

    12-week follow-up

  • Serum high-sensitivity C-reactive protein at baseline and 12-week follow-up

    12-week follow-up

Study Arms (2)

probiotic group

EXPERIMENTAL

consumed 2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)

Dietary Supplement: dual probiotics

placebo group

PLACEBO COMPARATOR

consumed 2g of powder daily without probiotics

Dietary Supplement: placebo

Interventions

dual probioticsDIETARY_SUPPLEMENT

2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)

Also known as: probiotic
probiotic group
placeboDIETARY_SUPPLEMENT

2g of powder daily without probiotics

placebo group

Eligibility Criteria

Age24 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nondiabetic (plasma fasting glucose, \<126mg/dL; 2-hour plasma glucose, \<200mg/dL)
  • borderline to moderate hypertriglyceridemia (plasma triglyceride, 150-500 mg/dL)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics

Seoul, 120-749, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26044516DERIVED

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Probiotics

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jong Ho Lee, PhD

    Yonsei University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2014

First Posted

August 13, 2014

Study Start

June 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

KR(1)