Effects of the Consumption of California Walnuts on Cardiovascular Health

Completed · Phase 1

Conditions studied: Cardiovascular Health, Immune Function

In brief

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

Key facts

Study ID

NCT01235390

Run by

University of California, Davis

People needed

36

Starts

2010-10-01

Expected to finish

2012-06-01

Last updated by the study team

2013-11-04

Who can join

Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ragle Human Nutrition Research Center — Davis, California, United States

Full record on ClinicalTrials.gov

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