Recruitment

Recruitment Status
Completed

Exclusion Criteria

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

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

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

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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