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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753907
• Other study ID #: LA_fu
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2016
• Last updated: April 25, 2016
• Start date: June 2015

Study information

• Verified date: April 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Yonsei University Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• Low LA
Individuals who replaced 10 mL soy oil with one apple
• 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

Locations

Country	Name	City	State
Korea, Republic of	Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lp-PLA2 activity (nmol/mL/min)		At baseline and end of each 8-week diet period	No
Secondary	Change in total cholesterol (mg/dL)		At baseline and end of each 8-week diet period	No
Secondary	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	No
Secondary	Change in HDL cholesterol (mg/dL)		At baseline and end of each 8-week diet period	No
Secondary	Change in triglyceride (mg/dL)		At baseline and end of each 8-week diet period	No