Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

NCT ID: NCT01925716

Last Updated: 2013-08-21

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

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-08-31

Brief Summary

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The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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cholesterol,LDL vegetable oils heart diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Corn oil/olive oil

Corn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days

Group Type EXPERIMENTAL

Corn oil

Intervention Type OTHER

corn oil 56 g/day for 21 days

Olive oil

Intervention Type OTHER

olive oil 56 g /day for 21 days

Olive Oil/Corn Oil

olive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days

Group Type EXPERIMENTAL

Corn oil

Intervention Type OTHER

corn oil 56 g/day for 21 days

Olive oil

Intervention Type OTHER

olive oil 56 g /day for 21 days

Interventions

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Corn oil

corn oil 56 g/day for 21 days

Intervention Type OTHER

Olive oil

olive oil 56 g /day for 21 days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
* Fasting triglycerides less than or equal to 350 mg/dL at visit 1

Exclusion Criteria

* Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
* Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
* Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PepsiCo Global R&D

INDUSTRY

Sponsor Role collaborator

ACH Food Companies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin C Maki, PhD

Role: STUDY_DIRECTOR

Biofortis Clinical Research, Inc.

References

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Maki KC, Lawless AL, Kelley KM, Kaden VN, Geiger CJ, Dicklin MR. Corn oil improves the plasma lipoprotein lipid profile compared with extra-virgin olive oil consumption in men and women with elevated cholesterol: results from a randomized controlled feeding trial. J Clin Lipidol. 2015 Jan-Feb;9(1):49-57. doi: 10.1016/j.jacl.2014.10.006. Epub 2014 Oct 23.

Reference Type DERIVED
PMID: 25670360 (View on PubMed)

Other Identifiers

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PRV-1303

Identifier Type: -

Identifier Source: org_study_id