Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT02312492
Eligibility Criteria:
Inclusion Criteria:
* 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 (C reactive protein) \<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 (thyroid stimulating hormone)
* Normal gastrointestinal function
* Normotensive on or off medication
* Non-smoker for at least 2 years
* Alcohol intake \< 7 drinks per week, and willingness to abstain from consuming alcohol while participating in the study.
* Consistent physical activity
* Willingness to follow protocol as detailed in the Institutional Review Board (IRB) approved consent form.
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:
* 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)
* 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT02312492
Study Brief:
Protocol Section:
NCT02312492