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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oleic acid diet | Experimental | Participants are provided with meals enriched in oleic acid (18:1) |
|
| palmitic acid diet | Experimental | Participants are provided with meals enriched in palmitic acid (18:0) |
|
| stearic acid diet | Experimental | Participants are provided with meals enriched in stearic acid (18:0) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diet | Other | Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| inflammation | 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). | 15-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| lymphocyte proliferation and ex vivo cytokine secretion | IL-1, IL-6, TNF-alpha, and prostaglandin E2 (PGE2) | 15 weeks |
| plasma lipids and lipoproteins | TC, HDL, LDL |
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Inclusion Criteria:
The inclusion and exclusion criteria for both studies A and B are identical.
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
Exclusion criteria:
Men
Women who have had a double mastectomy
Age < 50 and > 85 years
BMI < 20 and > 35 kg/m2
LDL-cholesterol <100 mg/dL
CRP > 10 ug/dL
Abnormal fasting plasma glucose levels >120 mg/dL
Use of medications known to affect lipid metabolism:
Renal or kidney disease, as defined by a history of chronic kidney disease or by glomerular filtration rate of < 60 ml.min/1.73 m2 calculated from screening blood tests.
Hypothyroidism or hyperthyroidism, as defined as screening TSH outside of normal ranges (<0.4 or >4.5), unless controlled with medication for at least 6 months
Gastrointestinal disease
Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
Anemia, as defined by screening haemoglobin <11.7g/dL.
Liver disease, as defined by a history of chronic hepatitis B or C, cholestatic or cirrhotic liver disease, nonalcoholic fatty liver disease, elevations of SGPT or SGOT greater than 1.5 times the upper limit of normal at screening, bilirubin greater than 2 mg/dL (in the absence of benign causes of elevated bilirubin such as Gilbert's syndrome) at screening, or albumin below the lower limit of normal.
Type I and II diabetes
Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
Smoking or use of nicotine-containing products within the past 2 years
Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
Unwillingness to maintain body weight during participation in the study
Unwillingness to adhere to diet and study protocol
Weight gain or loss of more than 15 lb within 6 months prior to enrollment
Vegetarians and those with food allergies or aversions
Non-English speaking subjects
No Social Security number
Women who have a history of difficulty with blood draws
Blood donation within the past 8 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Alice H Lichtenstein, D.Sc. | Tufts University/HNRCA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Mayer Human Nutrition Research Center on Aging | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31179489 | Derived | Meng H, Matthan NR, Wu D, Li L, Rodriguez-Morato J, Cohen R, Galluccio JM, Dolnikowski GG, Lichtenstein AH. Comparison of diets enriched in stearic, oleic, and palmitic acids on inflammation, immune response, cardiometabolic risk factors, and fecal bile acid concentrations in mildly hypercholesterolemic postmenopausal women-randomized crossover trial. Am J Clin Nutr. 2019 Aug 1;110(2):305-315. doi: 10.1093/ajcn/nqz095. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 15 weeks |
| desaturase activity | 8CD, D6D, D5D | 15 weeks |
| insulin sensitivity | glucose, insulin | 15 weeks |
| coagulation biomarkers | prothrombin time (PT), partial thromboplastin time (PTT) | 15 weeks |