Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation
Completed · Not applicable
Conditions studied: Dyslipidemia
In brief
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.
Key facts
- Study ID
- NCT02145936
- Run by
- Tufts University
- People needed
- 20
- Starts
- 2013-01-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-07-13
Who can join
Age: 50 and older, up to 85. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
- 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)
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Hormone therapy medications containing estrogen
- Probucol
- 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.) in the last 3 months prior to participation in the study
- Anabolic steroids and hydrocortisone
- 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)
Where it is running
- Jean Mayer Human Nutrition Research Center on Aging — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.