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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02609295

Enrollment

Registered

2015-11-20

Start date

2015-02-28

Completion date

2015-08-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2

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).

Interventions

DIETARY_SUPPLEMENTPlacebo

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

DIETARY_SUPPLEMENTALA group

1.2 g (two capsules) of perilla oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 68 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Collagen-Epinephrine Closure Time (C-EPI CT)	Baseline

Secondary

Measure	Time frame
Prothrombin Time (PT)	Baseline
Activated partial thromboplastin time (aPTT)	Baseline
Fibrinogen	Baseline

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026