Dyslipidemia
Conditions
Keywords
fatty acid
Brief summary
The purpose of this study is to to determine the effect of habituation to diets with different types of dietary fat (stearic, palmitic and oleic) on selected Cardiovascular Disease (CVD) risk indicators with an emphasis on inflammation.
Detailed description
Vegetable oils high in the specific fatty acids of interest - stearic (found in cocoa butter, meats), palmitic (found in meats, dairy and some plant oils) and stearic acid's metabolic product, oleic (found in olive and corn oil) - will be used to displace each other in a standardized diet and fed to mildly hypercholesterolemic postmenopausal women using a randomized-controlled crossover design. A critical issue remains unresolved - the relative comparability among . The findings from this research study will enable us to understand the mechanism and potential health effect of different types of fats. Each of the diet phases will be 5 weeks in length with a 2-4 week break between phases. All food and drink will be provided to study volunteers. Blood pressure and body weight will be monitored once per week and adjustments made, if necessary, to maintain a stable weight. During the 5th week of each diet phase, volunteers will come to the center on 3 consecutive days to provide fasting blood samples and a non-fasting blood sample.
Interventions
OTHERdiet
Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
Sponsors
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
The inclusion and
Exclusion criteria
for both studies A and B are identical. * Postmenopausal women (menopause defined by complete natural cessation of menses for \>12 months or a bilateral oophorectomy). * Age \>50 to \< 85 years * BMI \>20 to \<35 kg/m2 * LDL-cholesterol \>100 mg/dL * CRP \<10 ug/dL * Normal fasting plasma glucose levels (\<120 mg/dL) * Not taking medication known to affect lipid metabolism: HMG-CoA reductase inhibitors (statins) * Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.) * Cholesterol Absorption Inhibitors (Ezetimibe \[Zetia\]) * Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc) * Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate \[Tricor\], etc) * Probucol * Anticoagulants (Coumadin, Heparin, Plavix, etc) * Hormone therapy medications containing estrogen * Acetylsalicylic acid containing medications, aspirin * Diphenylhydantoin * Supplements containing fatty acids (Fish Oil, Flaxseed, etc.) and any other compounds that affect lipid metabolism (red yeast rice, etc.) for at least 3 months prior to participation in the study * Anabolic steroids * Hydrocortisone * Normal kidney function as assessed by serum creatinine and blood urea nitrogen * Normal liver function as assessed by serum glutamic pyruvic transaminase, serum glutamic oxaloacetic transaminase and alkaline phosphatase * Normal thyroid function as assessed by serum TSH * Normal gastrointestinal function * Normotensive on or off medication * Non-smoker for at least 2 years * Alcohol intake \< 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study. * Consistent physical activity * Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammation | 15-weeks | interleukine (IL)-6, tumor necrosis factor (TNF)-alpha, monocyte chemoattractant protein (MCP)-1, C-reactive protein (CRP), soluble forms of intercellular adhesion protein (slCAM)-1, vascular cell adhesion protein (sVCAM)-1, sE-selectin, sP-selectin and li0poprotein associated phospholipase A2 (LpPLA2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lymphocyte proliferation and ex vivo cytokine secretion | 15 weeks | IL-1, IL-6, TNF-alpha, and prostaglandin E2 (PGE2) |
| plasma lipids and lipoproteins | 15 weeks | TC, HDL, LDL |
| desaturase activity | 15 weeks | 8CD, D6D, D5D |
| insulin sensitivity | 15 weeks | glucose, insulin |
| coagulation biomarkers | 15 weeks | prothrombin time (PT), partial thromboplastin time (PTT) |
Countries
United States
Outcome results
None listed