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Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01925716
Enrollment
57
Registered
2013-08-20
Start date
2013-03-31
Completion date
2013-08-31
Last updated
2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

cholesterol,LDL, vegetable oils, heart diseases

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

Interventions

corn oil 56 g/day for 21 days

OTHEROlive oil

olive oil 56 g /day for 21 days

Sponsors

PepsiCo Global R&D
CollaboratorINDUSTRY
ACH Food Companies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Low Density Lipoprotein cholesterolTime 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

MeasureTime frame
total cholesterolbaseline (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

MeasureTime frame
High density lipoprotein cholesterolbaseline (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-Cholesterolbaseline (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
Triglyceridesbaseline (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
Total cholesterol/HDL-C ratiobaseline (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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026