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

Phase 3

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: ALA group

• Registration Number: NCT02609295
• Lead Sponsor: Yonsei University

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).

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily
ALA group	ALA group	Individuals who consumed 1.2 g (two capsules) of perilla oil daily

Primary Outcome Measures

Name	Time	Method
Collagen-Epinephrine Closure Time (C-EPI CT)	8-week follow up

Secondary Outcome Measures

Name	Time	Method
Fibrinogen	8-week follow up
Activated partial thromboplastin time (aPTT)	8-week follow up
Prothrombin Time (PT)	8-week follow up

Trial Locations

Locations (1)

Yonsei University; 🇰🇷 Seoul, Korea, Republic of