Cardiovascular Disease
Conditions
Keywords
trans fatty acids, ruminant, cardiovascular disease
Brief summary
The objectives of this study are to : 1) determine if vaccenic acid (trans-11-octadecenoic, a naturally occurring trans fatty acid isomer from ruminant animal products) raises LDL cholesterol in a quantitatively comparable manner as mixed trans fatty acid isomers from partially hydrogenated vegetable oils at 3% of energy intake, 2) determine if cis-9, trans-11 conjugated linoleic acid (a naturally occurring polyunsaturated fatty acid from ruminant animal products) raises LDL cholesterol compared to a control diet, and 3) demonstrate that mixed trans fatty acid isomers from partially hydrogenated vegetable oil raises LDL cholesterol compared to a low trans fatty acid diet.
Interventions
OTHERPHVO
base diet plus 3.0% energy mixed isomers of trans fatty acids from partially hydrogenated vegetable oil
OTHERCLA
base diet plus 1.0% energy added from cis-9, trans-11 conjugated linoleic acid
OTHERVA
base diet plus 3.0% energy added from vaccenic acid
OTHERbase
base diet containing approximately 0.1% energy of mixed trans fatty acid isomers
Sponsors
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 20 and 38 kg/m2 * Age 25 to 65 years during the intervention * Fasting glucose \< 126 mg/dl * Blood pressure \< 160/100 mm Hg (controlled with certain medications) * Total plasma cholesterol \< 280 mg/dl * Fasting triglycerides \< 300 mg/dl
Exclusion criteria
* Use of prescription or over-the-counter medications or supplements that alter lipid metabolism. * History or presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes. * Type 2 diabetes requiring the use of oral antidiabetic agents or insulin. * History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets). * Women who have given birth during the previous 12 months, pregnant women, women who plan to become pregnant or who become pregnant during the study or lactating women. * Volunteers who routinely participate in heavy exercise or volunteers who initiate an exercise program during the study. * Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months. * Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity. * Active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months). * Smokers or other tobacco users (during the 6 months prior to the start of the study). * Unable or unwilling to give informed consent or communicate with study staff. * Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion). * Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol | 4 weeks |
Countries
United States
Outcome results
None listed