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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02609295
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : January 22, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Placebo Dietary Supplement: ALA group Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02609295

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Korea, Republic of
Yonsei University
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT02609295    
Other Study ID Numbers: HP-ALA-hyperchol
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by Yonsei University:
α-linolenic acid
perilla oil
Collagen-epinephrine closure time
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Perilla seed oil
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents