Effects of California Walnuts on Vascular Function in Postmenopausal Women

Completed · Phase 1

Conditions studied: Cardiovascular Diseases

In brief

To determine the potential acute cardiovascular benefits of California Walnuts in postmenopausal women of ages 55-70. Primary outcome measures: * Vascular function * Platelet reactivity We hypothesize that the consumption of California walnuts will improve vascular function and platelet reactivity.

Key facts

Study ID

NCT01072864

Run by

University of California, Davis

People needed

5

Starts

2010-06-01

Expected to finish

2010-09-01

Last updated by the study team

2010-11-01

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 up to 40 g of California walnuts.
• BMI 18.5-34.9 kg/m2
• Weight ≥ 110 pounds

You may not qualify if…

• BMI ≥ 35 kg/m2
• Weight <110 pounds
• Diabetes
• Taking anticoagulation medication including NSAIDs
• 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).
• Renal or liver disease
• Heart disease, which includes cardiovascular events and Stroke
• Cushing's syndrome
• 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 CMP (laboratory values outside the reference range) if determined to be clinically significant.
• History of cancer
• History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year.
• Use of MAOI inhibitor within the last 1 year (e.g. phenelzine (Nardil), tranylcypromine (Parnate), etc)
• Malabsorption
• Anxiety medications
• 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, 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 multivitamin/mineral supplements
• Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils in the past 3-6 months.
• Nut allergies
• Soy-derived supplements
• Soy/soy products consumption > 2 servings/week

Where it is running

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

Full record on ClinicalTrials.gov

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