Recruitment

Recruitment Status
Completed

Exclusion Criteria

Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
Unwillingness to maintain body weight during participation in the study
Weight gain or loss of more than 15 lb within 6 months prior to enrollment
...
Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
Unwillingness to maintain body weight during participation in the study
Weight gain or loss of more than 15 lb within 6 months prior to enrollment
Anticoagulants (Coumadin, Heparin, Plavix, etc)
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.
Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
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
Acetylsalicylic acid containing medications, aspirin
Hormone therapy medications containing estrogen
Blood donation within the past 8 weeks
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
CRP > 10 ug/dL
Men
Diphenylhydantoin
Abnormal fasting plasma glucose levels >120 mg/dL
Anabolic steroids and hydrocortisone
HMG-CoA reductase inhibitors (statins)
Unwillingness to adhere to diet and study protocol
Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
BMI < 20 and > 35 kg/m2
Smoking or use of nicotine-containing products within the past 2 years
Type I and II diabetes
No Social Security number
Age < 50 and > 85 years
Gastrointestinal disease
Women who have a history of difficulty with blood draws
Non-English speaking subjects
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.
Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
Probucol
Anemia, as defined by screening haemoglobin <11.7g/dL.
Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
Vegetarians and those with food allergies or aversions
Women who have had a double mastectomy
Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
LDL-cholesterol <100 mg/dL
Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)

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

Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
Unwillingness to maintain body weight during participation in the study
Weight gain or loss of more than 15 lb within 6 months prior to enrollment
...
Established cardiovascular disease as defined by history of myocardial infarction, stroke, heart failure, coronary artery bypass graft, stenosis >50%, angina and peripheral arterial disease)
Unwillingness to maintain body weight during participation in the study
Weight gain or loss of more than 15 lb within 6 months prior to enrollment
Anticoagulants (Coumadin, Heparin, Plavix, etc)
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.
Uncontrolled hypertension or high BP reading at the discretion of the study physician or nurse
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
Acetylsalicylic acid containing medications, aspirin
Hormone therapy medications containing estrogen
Blood donation within the past 8 weeks
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
CRP > 10 ug/dL
Men
Diphenylhydantoin
Abnormal fasting plasma glucose levels >120 mg/dL
Anabolic steroids and hydrocortisone
HMG-CoA reductase inhibitors (statins)
Unwillingness to adhere to diet and study protocol
Cholesterol Absorption Inhibitors (Ezetimibe [Zetia])
Alcohol intake > 7 drinks per week or unwillingness to abstain from consuming alcohol while participating in the study
BMI < 20 and > 35 kg/m2
Smoking or use of nicotine-containing products within the past 2 years
Type I and II diabetes
No Social Security number
Age < 50 and > 85 years
Gastrointestinal disease
Women who have a history of difficulty with blood draws
Non-English speaking subjects
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.
Fibrates (Gemfibrozil, Clofibrate, Ciprofibrate, Fenofibrate [Tricor], etc)
Probucol
Anemia, as defined by screening haemoglobin <11.7g/dL.
Nicotinic Acid Agents (Niacin, Niacor, Slo-Niacin, etc)
Vegetarians and those with food allergies or aversions
Women who have had a double mastectomy
Any non-steroidal anti-inflammatory drugs (NSAID) or antihistamine use by subject for 72 hours prior to blood draws
LDL-cholesterol <100 mg/dL
Bile Acid Sequestrants (Cholestyramine, Colestipol, Colesevelam, etc.)

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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