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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT00175071
First received: September 8, 2005
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Hyperlipidemias
Metabolic Syndrome X
Cardiovascular Diseases
 Behavioral: Comparison of cooking oils

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:
  • Serum lipid, lipoprotein and apolipoprotein concentrations, measures of inflammation, CETP and LCAT activities, endogenous lipid synthesis rates, expression of genes associated with lipoprotein metabolism [ Time Frame: 5 weeks period ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 CRP as well as indicators of how lipids are processed in the blood will be measured at the end of each dietary phase.

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 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175071

Locations
United States, Massachusetts
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
  More Information

Additional Information:
Click here for more information about this study:  This link exits the ClinicalTrials.gov site

No publications provided by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT00175071     History of Changes
Other Study ID Numbers: HL54727-1537
Study First Received: September 8, 2005
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Hyperlipidemias
Metabolic Syndrome X
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 16, 2013