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Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corn oil
Olive oil
Sponsored by
ACH Food Companies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypercholesterolemia focused on measuring cholesterol,LDL, vegetable oils, heart diseases

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Corn oil/olive oil

    Olive Oil/Corn Oil

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Low Density Lipoprotein cholesterol

    Secondary Outcome Measures

    total cholesterol

    Full Information

    First Posted
    August 14, 2013
    Last Updated
    August 19, 2013
    Sponsor
    ACH Food Companies, Inc.
    Collaborators
    PepsiCo Global R&D
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01925716
    Brief Title
    Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids
    Official Title
    A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ACH Food Companies, Inc.
    Collaborators
    PepsiCo Global R&D

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia
    Keywords
    cholesterol,LDL, vegetable oils, heart diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Corn oil/olive oil
    Arm Type
    Experimental
    Arm Description
    Corn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days
    Arm Title
    Olive Oil/Corn Oil
    Arm Type
    Experimental
    Arm Description
    olive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days
    Intervention Type
    Other
    Intervention Name(s)
    Corn oil
    Intervention Description
    corn oil 56 g/day for 21 days
    Intervention Type
    Other
    Intervention Name(s)
    Olive oil
    Intervention Description
    olive oil 56 g /day for 21 days
    Primary Outcome Measure Information:
    Title
    Low Density Lipoprotein cholesterol
    Time Frame
    Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
    Secondary Outcome Measure Information:
    Title
    total cholesterol
    Time Frame
    baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
    Other Pre-specified Outcome Measures:
    Title
    High density lipoprotein cholesterol
    Time Frame
    baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
    Title
    Non-HDL-Cholesterol
    Time Frame
    baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
    Title
    Triglycerides
    Time Frame
    baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
    Title
    Total cholesterol/HDL-C ratio
    Time Frame
    baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin C Maki, PhD
    Organizational Affiliation
    Biofortis Clinical Research, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25670360
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

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