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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609295
• Other study ID #: HP-ALA-hyperchol
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2015
• Last updated: January 21, 2016
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 68 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Placebo
1.2 g (two capsules) of medium-chain triglyceride (MCT) oil
• ALA group
1.2 g (two capsules) of perilla oil

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collagen-Epinephrine Closure Time (C-EPI CT)		Baseline	Yes
Primary	Collagen-Epinephrine Closure Time (C-EPI CT)		8-week follow up	Yes
Secondary	Prothrombin Time (PT)		Baseline	Yes
Secondary	Prothrombin Time (PT)		8-week follow up	Yes
Secondary	Activated partial thromboplastin time (aPTT)		Baseline	Yes
Secondary	Activated partial thromboplastin time (aPTT)		8-week follow up	Yes
Secondary	Fibrinogen		Baseline	Yes
Secondary	Fibrinogen		8-week follow up	Yes