Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Effect of Conventional and Reformulated Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 13, 2018
July 1, 2018
3.1 years
September 8, 2005
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Comparison of cooking oils
EXPERIMENTALPostmenopausal women (50-85 y) with LDL cholesterol 120 mg/dL.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Gender: female
- Age: 50-85 years
- LDL-C concentrations \>120 mg/dL
- Menopausal status: postmenopausal
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tufts Universitylead
Study Sites (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (1)
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.
PMID: 19423109DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice H Lichtenstein, D.Sc.
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 15, 2005
Study Start
March 1, 2004
Primary Completion
April 1, 2007
Study Completion
July 1, 2012
Last Updated
July 13, 2018
Record last verified: 2018-07