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Completed

NCT Number: NCT02609295

Effects of α-linolenic Acid Supplementation on Hemostasis 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.

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Key information

Age range

40 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University

Seoul, 03722, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

ALA group

Dietary Supplement

1.2 g (two capsules) of perilla oil

Primary outcomes

  1. Collagen-Epinephrine Closure Time (C-EPI CT)

    Time frame: Baseline

  2. Collagen-Epinephrine Closure Time (C-EPI CT)

    Time frame: 8-week follow up

Secondary outcomes

  1. Prothrombin Time (PT)

    Time frame: Baseline

  2. Prothrombin Time (PT)

    Time frame: 8-week follow up

  3. Activated partial thromboplastin time (aPTT)

    Time frame: Baseline

  4. Activated partial thromboplastin time (aPTT)

    Time frame: 8-week follow up

  5. Fibrinogen

    Time frame: Baseline

  6. Fibrinogen

    Time frame: 8-week follow up

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2015
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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