Effect of Dietary Fatty Acids on Cardiovascular Disease Risk Indicators and Inflammation
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Exclusion Criteria
- HMG-CoA reductase inhibitors (statins)
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- ...
- HMG-CoA reductase inhibitors (statins)
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- Unwillingness to maintain body weight during participation in the study
- BMI < 20 and > 35 kg/m2
- Anabolic steroids and hydrocortisone
- No Social Security number
- Blood donation within the past 8 weeks
- Smoking or use of nicotine-containing products within the past 2 years
- Type I and II diabetes
- Men
- Age < 50 and > 85 years
- Women who have had a double mastectomy
- CRP > 10 ug/dL
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
- 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.
- Acetylsalicylic acid containing medications, aspirin
- LDL-cholesterol <100 mg/dL
- Vegetarians and those with food allergies or aversions
- Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
- Anemia, as defined by screening haemoglobin <11.7g/dL.
- Probucol
- Diphenylhydantoin
- Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Women who have a history of difficulty with blood draws
- Unwillingness to adhere to diet and study protocol
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Abnormal fasting plasma glucose levels >120 mg/dL
- 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
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Non-English speaking subjects
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- 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
- Hormone therapy medications containing estrogen
- Gastrointestinal disease
- 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.
Summary
- Conditions
- Dyslipidemia
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 85 years
- Gender
- Only females
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...
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.
Exclusion Criteria
- HMG-CoA reductase inhibitors (statins)
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- ...
- HMG-CoA reductase inhibitors (statins)
- Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
- Weight gain or loss of more than 15 lb within 6 months prior to enrollment
- Unwillingness to maintain body weight during participation in the study
- BMI < 20 and > 35 kg/m2
- Anabolic steroids and hydrocortisone
- No Social Security number
- Blood donation within the past 8 weeks
- Smoking or use of nicotine-containing products within the past 2 years
- Type I and II diabetes
- Men
- Age < 50 and > 85 years
- Women who have had a double mastectomy
- CRP > 10 ug/dL
- Anticoagulants (Coumadin, Heparin, Plavix, etc)
- Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
- 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.
- Acetylsalicylic acid containing medications, aspirin
- LDL-cholesterol <100 mg/dL
- Vegetarians and those with food allergies or aversions
- Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
- Anemia, as defined by screening haemoglobin <11.7g/dL.
- Probucol
- Diphenylhydantoin
- Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
- Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)
- Women who have a history of difficulty with blood draws
- Unwillingness to adhere to diet and study protocol
- Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
- Abnormal fasting plasma glucose levels >120 mg/dL
- 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
- Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
- Non-English speaking subjects
- Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
- 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
- Hormone therapy medications containing estrogen
- Gastrointestinal disease
- 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.
Tracking Information
- NCT #
- NCT02145936
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Alice H Lichtenstein, D.Sc. Tufts University/HNRCA
- Alice H Lichtenstein, D.Sc. Tufts University/HNRCA
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