Cardiovascular Health Clinical Trial
Official title:
Effects of California Walnuts on Vascular Function and Immune Health in Postmenopausal Women
The purpose of this study is to determine the effects of the 4-week consumption of
California walnuts on vascular function and immune health in postmenopausal women of ages
50-70.
Primary outcome measures:
- vascular endothelial function
- platelet reactivity
- indoleamine 2, 3-deoxygenase (IDO)
Secondary outcome measures:
- relationship of walnut intake to lipoprotein, fatty acids and oxylipins
Status | Completed |
Enrollment | 36 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 50 to 70 years of age - Lack of menses in the last year and FSH 23-116.3 mlU/mL - Subject is willing and able to comply with the study protocols. - Subject is willing to consume California walnuts daily for four weeks. - BMI 18.5-34.9 kg/m2 - Weight = 110 pounds Exclusion Criteria: - BMI = 35 kg/m2 - Self reported use of anticoagulation agents including NSAIDs - Self reported use of oral cortisone or other immunosuppressive agents, - Self reported underlying neoplasia or immunological disease, - Dislike of walnuts - Food faddists or those taking a non-traditional diet - Self reported physical activity restricted or reduced due to chronic health conditions - Self reported diabetes - Blood pressure = 160/90 mm Hg - PFA-100 readings 10 % outside of normal reference range (normal reference range for ADP-Collagen: 71-118 sec; Epinephrine-Collagen: 94-193 sec). - Self reported renal or liver disease - Self reported heart disease, which includes cardiovascular events and Stroke - Self reported Cushing's syndrome - Self reported chronic/routine high intensity exercise - Inability to properly place or wear the PAT probes or abnormal measurements on pre-screening PAT - Abnormal Liver, CBC or Chemistry panels (laboratory values outside the reference range) if determined to be clinically significant by Dr. M. Eric Gershwin. - Self reported cancer within past 5 years - Self reported history of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year. - Self reported use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil), tranylcypromine (Parnate), etc) - Self reported malabsorption - Self reported anxiety medications - Self reported routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, hypertensive medications, such as ACE-inhibitors and beta-blockers. - Asthma (can be worsened by mild to moderate food allergies). - Indications of substance or alcohol abuse within the last 3 years - Use of multi-vitamin and mineral other than a general formula of vitamins and minerals that meet the RDA - Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months, and unwilling to discontinue use while participating in the study. - Self reported nut allergies |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Ragle Human Nutrition Research Center | Davis | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | California Walnut Commission |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial function | Endothelial function is assessed by using peripheral arterial tonometry (PAT). | 0 and 4 hours, 4 weeks after | No |
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