NCT02609295

Brief Summary

This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3

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

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

November 16, 2015

Last Update Submit

January 21, 2016

Conditions

Hypercholesterolemia

Keywords

α-linolenic acidperilla oilaPTTCollagen-epinephrine closure timeLp-PLA2

Outcome Measures

Primary Outcomes (2)

  • Collagen-Epinephrine Closure Time (C-EPI CT)

    Baseline

  • Collagen-Epinephrine Closure Time (C-EPI CT)

    8-week follow up

Secondary Outcomes (6)

  • Prothrombin Time (PT)

    Baseline

  • Prothrombin Time (PT)

    8-week follow up

  • Activated partial thromboplastin time (aPTT)

    Baseline

  • Activated partial thromboplastin time (aPTT)

    8-week follow up

  • Fibrinogen

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily

Dietary Supplement: Placebo

ALA group

EXPERIMENTAL

Individuals who consumed 1.2 g (two capsules) of perilla oil daily

Dietary Supplement: ALA group

Interventions

PlaceboDIETARY_SUPPLEMENT

1.2 g (two capsules) of medium-chain triglyceride (MCT) oil

Placebo
ALA groupDIETARY_SUPPLEMENT

1.2 g (two capsules) of perilla oil

ALA group

Eligibility Criteria

Age40 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntarily agree to participate and sign in informed consent form
  • Adults aged 40-70
  • Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)

You may not qualify if:

  • Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
  • Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
  • Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
  • Pregnant or lactating women, alcoholic, mental patient
  • Judged to be inappropriate for the study by the investigator after reviewing other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 20, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

KR(1)