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CompletedNCT02753907Updated Apr 28, 2016

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

A Phase 3 interventional study of Low LA and High LA in Healthy Subjects, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-28.

Sponsored by Yonsei University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study summary

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.

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Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Low LA (linoleic acid)

    Individuals who replaced 10 mL soy oil with one apple

    Dietary Supplement: Low LA

  • 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

Interventions

  • Dietary supplementLow LA

    Individuals who replaced 10 mL soy oil with one apple

  • Dietary supplementHigh 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

06

What researchers measure

Primary outcomes

  1. Change in Lp-PLA2 activity (nmol/mL/min)

    Time frame: At baseline and end of each 8-week diet period

Secondary outcomes

  1. Change in total cholesterol (mg/dL)

    Time frame: At baseline and end of each 8-week diet period

  2. Change in LDL cholesterol (mg/dL)

    Lipids and lipoproteins, such as total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Apo A-I, Apo B

    Time frame: At baseline and end of each 8-week diet period

  3. Change in HDL cholesterol (mg/dL)

    Time frame: At baseline and end of each 8-week diet period

  4. Change in triglyceride (mg/dL)

    Time frame: At baseline and end of each 8-week diet period

07

Study locations

1 site
  • Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
    Seoul, 120-749, Korea, Republic of
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References and documents

Publications

  • Kim M, Kim M, Lee A, Yoo HJ, Her JS, Jee SH, Lee JH. Impact of 8-week linoleic acid intake in soy oil on Lp-PLA2 activity in healthy adults. Nutr Metab (Lond). 2017 May 8;14:32. doi: 10.1186/s12986-017-0186-2. eCollection 2017. PubMed 28503188 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02753907
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 28, 2016
Start date
Jun 2015
Primary completion
Sep 2015
Last update
Apr 28, 2016
View the source record on ClinicalTrials.gov ↗

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