NCT01925716

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

5 months

First QC Date

August 14, 2013

Last Update Submit

August 19, 2013

Conditions

Hypercholesterolemia

Keywords

cholesterol,LDLvegetable oilsheart diseases

Outcome Measures

Primary Outcomes (1)

  • Low Density Lipoprotein cholesterol

    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 Outcomes (1)

  • total cholesterol

    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 Outcomes (4)

  • High density lipoprotein cholesterol

    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

  • Non-HDL-Cholesterol

    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

  • Triglycerides

    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

  • +1 more other outcomes

Study Arms (2)

Corn oil/olive oil

EXPERIMENTAL

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

Other: Corn oilOther: Olive oil

Olive Oil/Corn Oil

EXPERIMENTAL

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

Other: Corn oilOther: Olive oil

Interventions

Corn oilOTHER

corn oil 56 g/day for 21 days

Corn oil/olive oilOlive Oil/Corn Oil
Olive oilOTHER

olive oil 56 g /day for 21 days

Corn oil/olive oilOlive Oil/Corn Oil

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25670360DERIVED

MeSH Terms

Conditions

HypercholesterolemiaHeart Diseases

Interventions

Corn OilOlive Oil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kevin C Maki, PhD

    Biofortis Clinical Research, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2013

First Posted

August 20, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08