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

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ClinicalTrials.gov Identifier: NCT02609295
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 20, 2015
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Collagen-Epinephrine Closure Time (C-EPI CT) [ Time Frame: Baseline ]
  • Collagen-Epinephrine Closure Time (C-EPI CT) [ Time Frame: 8-week follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02609295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2015)
  • Prothrombin Time (PT) [ Time Frame: Baseline ]
  • Prothrombin Time (PT) [ Time Frame: 8-week follow up ]
  • Activated partial thromboplastin time (aPTT) [ Time Frame: Baseline ]
  • Activated partial thromboplastin time (aPTT) [ Time Frame: 8-week follow up ]
  • Fibrinogen [ Time Frame: Baseline ]
  • Fibrinogen [ Time Frame: 8-week follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects
Official Title  ICMJE 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
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: Placebo
    1.2 g (two capsules) of medium-chain triglyceride (MCT) oil
  • Dietary Supplement: ALA group
    1.2 g (two capsules) of perilla oil
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Individuals who consumed 1.2 g (two capsules) of medium-chain triglyceride (MCT) oil daily
    Intervention: Dietary Supplement: Placebo
  • Experimental: ALA group
    Individuals who consumed 1.2 g (two capsules) of perilla oil daily
    Intervention: Dietary Supplement: ALA group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2015)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 68 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02609295
Other Study ID Numbers  ICMJE HP-ALA-hyperchol
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP