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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175071
• Other study ID #: HL54727-1537
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: July 2012

Study information

• Verified date: July 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hyperlipidemias
• Hyperlipoproteinemias
• Metabolic Syndrome X

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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