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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT01620567
Eligibility Criteria:
Inclusion Criteria:
* men and women age \> 50 years
* BMI 19-30 kg/m2
* lutein intake of \< 3 mg/d
* Docosahexaenoic acid intake \< 250 mg/d (including supplements)
* Mini mental state exam (MMSE) score \> 24
* Macular pigment density \< 0.4 at 0.5 degrees
* Beck Depression Inventory \< 20
* free of known disease
* BMI 19-29 kg/m2
* must be able to give written informed consent
* have normal hematologic parameters
* normal values of plasma albumin
* normal values for liver and kidney function (Appendix A)
* no use of carotenoid, n3 fatty acid, multivitamin/mineral, (\> 2 months).
Exclusion Criteria:
* history of active small bowel disease or resection
* atrophic gastritis
* hyperlipidemia (LDL \>120 mg/dL or triglycerides \>150 mg/dL)
* hypertension (\>150/90 mm Hg)
* diabetes, alcoholism (\>2 drinks/d or 14 drinks/week)
* pancreatic disease
* anemia, and bleeding disorders (as determined by screening interview)
* avocado, potato or chickpea allergy
* pregnancy or lactation
* diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn's disease, cystic fibroids (as determined by screening interview)
* medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview)
* use of antipsychotic, antimanic, anti-inflammatory, monoamine inhibitors, or dementia medications
* smoking or use of nicotine patches or gum (within past 6 months)
* use of drugs suspected of interfering with metabolism of blood clotting, e.g. warfarin (as determined by screening interview)
* subjects having extremely high dietary intakes of carotenoids as indicated by screening plasma values \> NHANES 95th percentile for lutein/zeaxanthin, beta-carotene, cryptoxanthin, or lycopene
* stroke,head injury with loss of consciousness or seizures.
* Non English speaking: This is a small study with a sample size. Logistically and financially, getting materials translated for such a small study is not feasible.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01620567
Study Brief:
Protocol Section:
NCT01620567