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

NCT ID: NCT02753907

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

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.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Low LA (linoleic acid)

Individuals who replaced 10 mL soy oil with one apple

Group Type EXPERIMENTAL

Low LA

Intervention Type DIETARY_SUPPLEMENT

Individuals who replaced 10 mL soy oil with one apple

Medium LA

Individuals who maintained their usual food intake

Group Type NO_INTERVENTION

No interventions assigned to this group

High LA

Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9 g of soy oil as a supplement

Group Type EXPERIMENTAL

High LA

Intervention Type 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

Interventions

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Low LA

Individuals who replaced 10 mL soy oil with one apple

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laboratory of Clinical Nutrigenetics/Nutrigenomics, Yonsei University.

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 28503188 (View on PubMed)

Other Identifiers

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LA_fu

Identifier Type: -

Identifier Source: org_study_id

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