Overview

This trial is active, not recruiting.

Conditions hyperlipidemias, metabolic syndrome x, cardiovascular diseases
Treatment comparison of cooking oils
Sponsor Tufts University
Start date March 2004
End date April 2007
Trial size 30 participants
Trial identifier NCT00175071, HL54727-1537

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.
comparison of cooking oils
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.

Primary Outcomes

Measure
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
time frame: 5 weeks period

Eligibility Criteria

Female participants from 50 years up to 85 years old.

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

Additional Information

Official title Effect of Conventional and Reformulated Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Principal investigator Alice H Lichtenstein, D.Sc.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Tufts University.