Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Corn oil; Other: Olive oil

• Registration Number: NCT01925716
• Lead Sponsor: ACH Food Companies, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-16
• Last Update Submitted: 2013-08-19
• Study First Posted: 2013-08-20
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Corn oil/olive oil	Corn oil	Corn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days
Corn oil/olive oil	Olive oil	Corn oil 56 g per day for 21 days followed by olive oil 56 g for 21 days
Olive Oil/Corn Oil	Corn oil	olive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days
Olive Oil/Corn Oil	Olive oil	olive oil, 56g per day for 21 days followed by corn oil, 56 g for 21 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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