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 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT00113061
Eligibility Criteria:
Inclusion Criteria:
* Physically inactive
* C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
* Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry
* Does not smoke
* Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10%
* Triglyceride levels no higher than 300 mg/dl
* Fasting glucose level less than 126
* Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than 90 mm Hg as measured at study entry
* If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory medications, must be on a stable dose for 6 months prior to study entry
* If taking a cholesterol medication, including statins, blood pressure medication (including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months prior to study entry
Exclusion Criteria:
* Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers)
* Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder
* Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting
* Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
* Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry
* Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months of study entry
* History of stroke or TIA
* History of cancer within at least 5 years of study entry
* Diabetes or glucose intolerance
* Planning on participating in any other research trials during the next year
* Currently pregnant
* Planning to becoming pregnant during the next year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00113061
Study Brief:
Protocol Section:
NCT00113061