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

Phase 3

Completed

• Conditions: Healthy Subjects
• Interventions: Dietary Supplement: Low LA; Dietary Supplement: High LA

• Registration Number: NCT02753907
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2015-09
• Status Verified: 2016-04
• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low LA (linoleic acid)	Low LA	Individuals who replaced 10 mL soy oil with one apple
High LA	High LA	Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9 g of soy oil as a supplement

Primary Outcome Measures

Name	Time	Method
Change in Lp-PLA2 activity (nmol/mL/min)	At baseline and end of each 8-week diet period

Secondary Outcome Measures

Name	Time	Method
Change in LDL cholesterol (mg/dL)	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
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
Change in total cholesterol (mg/dL)	At baseline and end of each 8-week diet period

Trial Locations

Locations (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.; 🇰🇷 Seoul, Korea, Republic of