Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers

Study Overview
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Brief Summary
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The current study is designed to assess the effect of a conventional cooking oil (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease risk factors.

Detailed Description
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It is known that in subjects with high cholesterol levels that substitution of hydrogenated fat (high in trans fat) with vegetable oil results in higher levels of total and LDL cholesterol (bad cholesterol). There has been tremendous interest within the food industry to identify cooking fats that have the physical properties necessary to make shelf stable products and have textural characteristics similar to existing products but that also favorably affects risk factors for coronary heart disease (CHD) such as LDL cholesterol levels and inflammatory markers. The current study is designed to assess the effect of a conventional cooking oil (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease risk factors.

Official Title
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Effect of Conventional and Reformulated Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers

Conditions
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Hyperlipidemias, Metabolic Syndrome X, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Comparison of cooking oils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender: female Age: 50-85 years LDL-C concentrations >120 mg/dL Menopausal status: postmenopausal Exclusion Criteria: Use of medications known to affect lipid metabolism Untreated thyroid disease Diabetes mellitus Abnormal kidney function Abnormal liver function Smoking Alcohol consumption > 2 drinks/day

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparison of cooking oils<br>Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL. | Behavioral: Comparison of cooking oils<br>* 30 subjects will consume each of the two diets in randomized order for 5 weeks each. Diets will be designed to maintain body weight; will have 30% of energy as fat which 2/3 or 20% of energy will be either the conventional or reformulated fat. Blood lipids and C reactive protein (CRP) as well as indicators of how lipids are processed in the blood will be measured at the end of each dietary phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum lipid, lipoprotein and apolipoprotein concentrations, measures of inflammation, cholesteryl ester transfer protein (CETP) and lecithin-cholesterol acetyltransferase (LCAT) activities, endogenous lipid synthesis rates, expression of genes associated |  | 5 weeks period |