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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo

ALA group

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2

Eligibility Criteria

40 Years - 68 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Yonsei University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ALA group

Arm Description

Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily

Individuals who consumed 1.2 g (two capsules) of perilla oil daily

Outcomes

Primary Outcome Measures

Collagen-Epinephrine Closure Time (C-EPI CT)

Secondary Outcome Measures

Prothrombin Time (PT)

Activated partial thromboplastin time (aPTT)

Fibrinogen

Full Information

NCT ID

NCT02609295

First Posted

November 16, 2015

Last Updated

January 21, 2016

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02609295

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

α-linolenic acid, perilla oil, aPTT, Collagen-epinephrine closure time, Lp-PLA2

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily

Arm Title

ALA group

Arm Type

Experimental

Arm Description

Individuals who consumed 1.2 g (two capsules) of perilla oil daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

ALA group

Intervention Description

1.2 g (two capsules) of perilla oil

Primary Outcome Measure Information:

Title

Collagen-Epinephrine Closure Time (C-EPI CT)

Time Frame

Baseline

Title

Collagen-Epinephrine Closure Time (C-EPI CT)

Time Frame

8-week follow up

Secondary Outcome Measure Information:

Title

Prothrombin Time (PT)

Time Frame

Baseline

Title

Prothrombin Time (PT)

Time Frame

8-week follow up

Title

Activated partial thromboplastin time (aPTT)

Time Frame

Baseline

Title

Activated partial thromboplastin time (aPTT)

Time Frame

8-week follow up

Title

Fibrinogen

Time Frame

Baseline

Title

Fibrinogen

Time Frame

8-week follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Yonsei University

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

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

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