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OpenTrials
Completed

NCT Number: NCT02753907

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

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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Key information

Conditions

Healthy Subjects

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 120-749, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low LA

Dietary Supplement

Individuals who replaced 10 mL soy oil with one apple

High LA

Dietary Supplement

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

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)

    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

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
First posted
Apr 28, 2016
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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