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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: ALA group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily | Dietary Supplement: Placebo<br>* 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil<br>|
| Experimental: ALA group<br>Individuals who consumed 1.2 g (two capsules) of perilla oil daily | Dietary Supplement: ALA group<br>* 1.2 g (two capsules) of perilla oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collagen-Epinephrine Closure Time (C-EPI CT) |  | Baseline | 
| Collagen-Epinephrine Closure Time (C-EPI CT) |  | 8-week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prothrombin Time (PT) |  | Baseline | 
| Prothrombin Time (PT) |  | 8-week follow up | 
| Activated partial thromboplastin time (aPTT) |  | Baseline | 
| Activated partial thromboplastin time (aPTT) |  | 8-week follow up | 
| Fibrinogen |  | Baseline | 
| Fibrinogen |  | 8-week follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2