Effects of California Walnuts on Vascular Function in Postmenopausal Women
1 other identifier
interventional
5
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 cardiovascular-diseases
Started Jun 2010
Shorter than P25 for phase_1 cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedNovember 1, 2010
October 1, 2010
2 months
February 18, 2010
October 28, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral Arterial Tonometry (PAT)
2 and 4 hours
Study Arms (4)
5 g of walnuts
EXPERIMENTAL20 g of walnuts
EXPERIMENTAL30 g of walnuts
EXPERIMENTAL40 g of walnuts
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- California Walnut Commissioncollaborator
Study Sites (1)
Ragle Human Nutrition Research Center
Davis, California, 95616, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M. Hackman, PhD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2010
First Posted
February 22, 2010
Study Start
June 1, 2010
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
November 1, 2010
Record last verified: 2010-10