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

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Yonsei University

Status and phase

Completed
Phase 3

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: Placebo
Dietary Supplement: ALA group

Study type

Interventional

Funder types

Other

Identifiers

NCT02609295
HP-ALA-hyperchol

Details and patient eligibility

About

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.

Full 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).

Enrollment

86 patients

Sex

All

Ages

40 to 68 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

86 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily
Treatment:
Dietary Supplement: Placebo
ALA group
Experimental group
Description:
Individuals who consumed 1.2 g (two capsules) of perilla oil daily
Treatment:
Dietary Supplement: ALA group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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