Last Verified: | January/31/2009 |
First Submitted: | February/19/2008 |
Estimated Enrollment Submitted: | February/27/2008 |
First Posted: | February/28/2008 |
Last Update Submitted: | February/17/2009 |
Last Update Posted: | February/18/2009 |
Actual Study Start Date: | January/31/2007 |
Estimated Primary Completion Date: | November/30/2007 |
Estimated Study Completion Date: | November/30/2007 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Prevention |
Masking: | None (Open Label) |
Ages Eligible for Study: | 50 Years to 50 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Generally healthy men and postmenopausal women age 50 or over - BMI 18.5-35 kg/m2 Exclusion Criteria: - Cigarette smoking and/or nicotine replacement use - History or known allergy to nuts of any kind - Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission - Individuals taking estrogen - Use of cholesterol-lowering medications - Gastrointestinal disease - Kidney disease - Endocrine disease: including diabetes, untreated thyroid disease - Rheumatoid arthritis - Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission - Systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg - Regular use of oral steroids - Regular daily intake of ≥ 2 alcoholic drinks - Illicit drug use - No fish oil supplements (including cod liver oil) for 6 weeks prior to study admission - No high dose (≥ 3X RDA) supplements of vitamins C, E, selenium, or beta-carotene for one month prior to study admission - No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission - No regular consumption of pomegranate juice (≥ 180 mL or 6 oz/d, ≥ 3 times/wk) for one month prior to study admission |