Effects of the Consumption of California Walnuts on Cardiovascular Health

NCT01235390 | Completed Phase 1

• 1 other identifier: 200917609-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 measures:

• vascular endothelial function
• platelet reactivity
• indoleamine 2, 3-deoxygenase (IDO) Secondary outcome measures:
• relationship of walnut intake to lipoprotein, fatty acids and oxylipins

Conditions

Cardiovascular Health; Immune Function

Keywords

Postmenopausal women; walnuts

Outcome Measures

Primary Outcomes (1)

• Endothelial function

  Endothelial function is assessed by using peripheral arterial tonometry (PAT).

  0 and 4 hours, 4 weeks after

Study Arms (2)

5 g of walnuts

EXPERIMENTAL

Dietary Supplement: Walnuts

40 g of walnuts

EXPERIMENTAL

Dietary Supplement: Walnuts

Interventions

Walnuts DIETARY_SUPPLEMENT

The consumption of assigned walnuts once a day during 4 weeks

40 g of walnuts; 5 g of walnuts

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

Sponsors & Collaborators

• University of California, Davis: lead
• California Walnut Commission: collaborator

Study Sites (1)

Ragle Human Nutrition Research Center

Davis, California, 95616, United States

Location

Study Officials

• Robert M Hackman, Ph. D

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 5, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

US (1)