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

NCT02753907 | Completed Phase 3

• 1 other identifier: LA_fu
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Change in Lp-PLA2 activity (nmol/mL/min)

  At baseline and end of each 8-week diet period

Secondary Outcomes (4)

• Change in total cholesterol (mg/dL)

  At baseline and end of each 8-week diet period

• Change in LDL cholesterol (mg/dL)

  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

Study Arms (3)

Low LA (linoleic acid)

EXPERIMENTAL

Individuals who replaced 10 mL soy oil with one apple

Dietary Supplement: Low LA

Medium LA

NO INTERVENTION

Individuals who maintained their usual food intake

High LA

EXPERIMENTAL

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

Interventions

Low LA DIETARY_SUPPLEMENT

Individuals who replaced 10 mL soy oil with one apple

Low LA (linoleic acid)

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

High LA

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, 120-749, South Korea

Location

Related Publications (1)

• Kim M, Kim M, Lee A, Yoo HJ, Her JS, Jee SH, Lee JH. Impact of 8-week linoleic acid intake in soy oil on Lp-PLA2 activity in healthy adults. Nutr Metab (Lond). 2017 May 8;14:32. doi: 10.1186/s12986-017-0186-2. eCollection 2017.

  PMID: 28503188 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 28, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

KR (1)