Status:
COMPLETED
Effects of the Consumption of California Walnuts on Cardiovascular Health
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
California Walnut Commission
Conditions:
Cardiovascular Health
Immune Function
Eligibility:
FEMALE
50-70 years
Phase:
PHASE1
Brief Summary
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 mea...
Detailed Description
Cardiovascular disease is the leading cause of morbidity and mortality in the United States. The initiation and progression of atherosclerotic vascular disease is multifactoral in nature, and includes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01235390
Start Date
October 1 2010
End Date
June 1 2012
Last Update
November 4 2013
Active Locations (1)
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1
Ragle Human Nutrition Research Center
Davis, California, United States, 95616