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

NCT ID: NCT02609295

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-08-31

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.

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).

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

ALA group

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

Group Type: EXPERIMENTAL

ALA group

Intervention Type: DIETARY_SUPPLEMENT

1.2 g (two capsules) of perilla oil

Interventions

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

ALA group

1.2 g (two capsules) of perilla oil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HP-ALA-hyperchol

Identifier Type: -

Identifier Source: org_study_id