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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02611102
Eligibility Criteria:
Inclusion Criteria:
1. DoD healthcare beneficiaries
2. willing to drink 2 to 4 cups of coffee daily
3. between the ages of 18 to 45
4. serum LDL-c \< 160,
5. non-HDL-c \< 190
6. apoB \< 120
Exclusion Criteria:
1. BMI \> 30kg/m2 or \< 20kg/m2 or waist circumference \> 102cm (males) or 88cm (females)
2. Triglycerides \> 150
3. Hypertension defined as SBP \> 150, DBP \> 90 or on treatment for high blood pressure
4. Chronic liver disease defined by any clinical or a history of serum AST or ALT \> 3 times ULN
5. Kidney disease defined as a GFR \<90 ml/min or history of nephritic syndrome
6. Impaired glucose metabolism defined as HbA1c \> 5.6, FBG \> 99, or 2-hour OGTT \> 139
7. Any known malignancy
8. Known malabsorption disorder to include inflammatory bowel disease, celiac disease, cystic fibrosis, history of gastric bypass
9. Hypothyroidism per lab evaluation at baseline
10. Pregnancy
11. Polycystic Ovary Syndrome or irregular menstrual periods
12. Subjects taking certain medications such as glucocorticoids, immunosuppressants (cyclosporine, sirolimus, etc.), tamoxifen, androgens, antipsychotics, hydrochlorothiazide, retinoids, beta-blockers, statins, bile acid sequestrants, niacin, fibrates, ezetimibe, high dose fish oil (\>1gm/day epa + dha), or any other supplement or pharmacologic agent known to alter lipoproteins
a. If on hormonal contraceptives, lipid panel must be stable over the past 12-24 months
13. Cushing's syndrome per medical history or clinical suspicion
14. HIV per medical history
15. Chronic Inflammatory Disorders such as, but not limited to, SLE, RA, IBD per medical history
16. History of tobacco use within the previous 12 months to include cigarettes, e-cigarettes, chewing tobacco, cigars, and pipes.
17. History of marijuana use within the previous 12 months
18. Active intentional weight loss of over 5% in the past 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02611102
Study Brief:
Protocol Section:
NCT02611102