Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects

January 21, 2016 updated by: Yonsei University

Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group [1.2 g (two capsules) of perilla oil daily; 497 mg ALA] and a placebo group (1.2 g of medium-chain triglyceride oil daily).

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily
Dietary supplement: Placebo
1.2 g (two capsules) of medium-chain triglyceride (MCT) oil
Experimental: ALA group
Individuals who consumed 1.2 g (two capsules) of perilla oil daily
Dietary supplement: ALA group
1.2 g (two capsules) of perilla oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collagen-Epinephrine Closure Time (C-EPI CT)
Time Frame: Baseline
Baseline
Collagen-Epinephrine Closure Time (C-EPI CT)
Time Frame: 8-week follow up
8-week follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Prothrombin Time (PT)
Time Frame: Baseline
Baseline
Prothrombin Time (PT)
Time Frame: 8-week follow up
8-week follow up
Activated partial thromboplastin time (aPTT)
Time Frame: Baseline
Baseline
Activated partial thromboplastin time (aPTT)
Time Frame: 8-week follow up
8-week follow up
Fibrinogen
Time Frame: Baseline
Baseline
Fibrinogen
Time Frame: 8-week follow up
8-week follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Estimate)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-ALA-hyperchol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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