Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Primary Purpose
Hyperlipidemias, Metabolic Syndrome X, Cardiovascular Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comparison of cooking oils
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemias
Eligibility Criteria
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
Sites / Locations
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Comparison of cooking oils
Arm Description
Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00175071
Brief Title
Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Official Title
Effect of Conventional and Reformulated Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Metabolic Syndrome X, Cardiovascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison of cooking oils
Arm Type
Experimental
Arm Description
Postmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.
Intervention Type
Behavioral
Intervention Name(s)
Comparison of cooking oils
Intervention Description
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice H Lichtenstein, D.Sc.
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19423109
Citation
Vega-Lopez S, Matthan NR, Ausman LM, Ai M, Otokozawa S, Schaefer EJ, Lichtenstein AH. Substitution of vegetable oil for a partially-hydrogenated fat favorably alters cardiovascular disease risk factors in moderately hypercholesterolemic postmenopausal women. Atherosclerosis. 2009 Nov;207(1):208-12. doi: 10.1016/j.atherosclerosis.2009.03.039. Epub 2009 Apr 5.
Results Reference
derived
Links:
URL
http://hnrc.tufts.edu
Description
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Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
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