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

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: Low LA
* Dietary Supplement: High LA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low LA (linoleic acid)<br>Individuals who replaced 10 mL soy oil with one apple | Dietary Supplement: Low LA<br>* Individuals who replaced 10 mL soy oil with one apple<br>|
| No Intervention: Medium LA<br>Individuals who maintained their usual food intake | |
| Experimental: High LA<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Lp-PLA2 activity (nmol/mL/min) |  | 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) |  | At baseline and end of each 8-week diet period | 
| Change in LDL cholesterol (mg/dL) | 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) |  | At baseline and end of each 8-week diet period | 
| Change in triglyceride (mg/dL) |  | At baseline and end of each 8-week diet period |