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

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT00175071

Collaborator

(none)

Enrollment

Location

Arm

100

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias Metabolic Syndrome X Cardiovascular Diseases	Behavioral: Comparison of cooking oils	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Comparison of cooking oils Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.	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.

Arm

Intervention/Treatment

Experimental: Comparison of cooking oils

Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

Tufts University

Investigators

Principal Investigator: Alice H Lichtenstein, D.Sc., Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Click here for more information about this study:

Publications

None provided.

Responsible Party:

Tufts University

ClinicalTrials.gov Identifier:

NCT00175071

Other Study ID Numbers:

HL54727-1537

First Posted:

Sep 15, 2005

Last Update Posted:

Jul 13, 2018

Last Verified:

Jul 1, 2018

Additional relevant MeSH terms:

Cardiovascular Diseases

Metabolic Syndrome

Hyperlipidemias

Study Results

No Results Posted as of Jul 13, 2018