Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

Hypercholesterolemia Clinical Trial

Official title:

A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925716
• Other study ID #: PRV-1303
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: August 19, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: ACH Food Companies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Corn oil
corn oil 56 g/day for 21 days
• Olive oil
olive oil 56 g /day for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ACH Food Companies, Inc.	PepsiCo Global R&D

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	Total cholesterol/HDL-C ratio		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	No
Primary	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	No
Secondary	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	No