Clinical trial NCT01925716: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: cholesterol,LDL
vegetable oils
heart diseases
Lead sponsor: ACH Food Companies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PepsiCo Global R&D
First posted: 2013-08-20
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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


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)

Primary outcomes:
measure: Low Density Lipoprotein cholesterol
timeFrame: 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:
measure: total cholesterol
timeFrame: 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:
measure: High density lipoprotein cholesterol
timeFrame: 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
measure: Non-HDL-Cholesterol
timeFrame: 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
measure: Triglycerides
timeFrame: 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
measure: Total cholesterol/HDL-C ratio
timeFrame: 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
Locations:
Study officials:
affiliation: Biofortis Clinical Research, Inc.
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
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.