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

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ClinicalTrials.gov Identifier: NCT02753907
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: Low LA Dietary Supplement: High LA Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2015
Actual Primary Completion Date : September 2015

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




Primary Outcome Measures :
  1. Change in Lp-PLA2 activity (nmol/mL/min) [ Time Frame: At baseline and end of each 8-week diet period ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753907


Locations
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Korea, Republic of
Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.
Seoul, Korea, Republic of, 120-749
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02753907     History of Changes
Other Study ID Numbers: LA_fu
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016