Impact of an 8-week Linoleic Acid Intake in Soy Oil on Lp-PLA2 Activity in Healthy Adults

April 25, 2016 updated by: Yonsei University
Self-reported healthy participants (n=150) aged 30-65 years with 18.5 kg/m^2 ≤ BMI < 30 kg/m^2 were randomly assigned into three groups: a low linoleic acid (LA, 18:2n-6) group (n=50) replaced 10 mL soy oil with one apple; a medium LA group (control group, n=50) maintained usual food intake; a high LA group (n=50) reduced 1/3 cup of cooked refined rice and consumed 9.9g of soy oil capsules daily as a supplement. Plasma fatty acids and lipoprotein-associated phospholipase A2 (Lp-PLA2) activity were measured at baseline and 8 week alongside other cardiovascular disease risk factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-749
        • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30 to 65 years at beginning of study
  • Subjects with BMI 18.5 to 30 kg/m^2

Exclusion Criteria:

  • Use of any medication or supplements that alter lipid metabolism.
  • Presence of dyslipidemia, diabetes mellitus, hypertension, liver disease, renal disease, chronic disease of the gastrointestinal tract, cerebrovascular disease, pancreatitis or cancer.
  • Women who pregnant or lactating.
  • Drug or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low LA (linoleic acid)
Individuals who replaced 10 mL soy oil with one apple
Dietary supplement: Low LA
Individuals who replaced 10 mL soy oil with one apple
No Intervention: Medium LA
Individuals who maintained their usual food intake
Experimental: High LA
Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9 g of soy oil as a supplement
Dietary supplement: High LA
Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9g (9 of 1.1g capsules, 3 capsules at every 3 meals a day) of soy oil as a supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Lp-PLA2 activity (nmol/mL/min)
Time Frame: At baseline and end of each 8-week diet period
At baseline and end of each 8-week diet period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total cholesterol (mg/dL)
Time Frame: At baseline and end of each 8-week diet period
At baseline and end of each 8-week diet period
Change in LDL cholesterol (mg/dL)
Time Frame: At baseline and end of each 8-week diet period
Lipids and lipoproteins, such as total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Apo A-I, Apo B
At baseline and end of each 8-week diet period
Change in HDL cholesterol (mg/dL)
Time Frame: At baseline and end of each 8-week diet period
At baseline and end of each 8-week diet period
Change in triglyceride (mg/dL)
Time Frame: At baseline and end of each 8-week diet period
At baseline and end of each 8-week diet period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • LA_fu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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