Effects of California Walnuts on Vascular Function in Postmenopausal Women

October 28, 2010 updated by: University of California, Davis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Epidemiological studies have shown that consumption of high amounts of plant foods, such as nuts, fruits and vegetables, appears to be protective against chronic diseases including heart disease, stroke, diabetes mellitus and metabolic syndrome. In recent years, numerous studies indicate that consumption of walnuts mainly containing α-linolenic acid (ALA), L-arginine and polyphenols beneficially alters vascular function and reduces inflammatory biomarkers. Recent studies have reported that consumption of walnuts is associated with beneficial effects in prevention of chronic diseases by favorably altering human serum profiles (i.e. decrease in LDL cholesterol and triglycerides and increase in HDL cholesterol and apolipoprotein A1) which are closely involved in the development of cardiovascular disease (CVD). In addition, recent reports by Dr. Ros and his colleagues indicate that addition of walnuts to a high-fat meal can improve endothelial function. This favorable influence on vasoactivity has been attributed to the antioxidant and anti-inflammatory properties of components of walnuts.

Due to their age and menopausal status, postmenopausal women in particular, are at a greater risk population for developing CVD. Males tend to show greater rates of CVD than pre-menopausal women, while women following menopause show an increase in the rates of CVD. This increase is associated with endothelial dysfunction and decreased vasodilation which are apparently expressed after menopause and become worse with age. In this study, we will define the effects of consuming California walnuts on vascular health.

We hypothesize that consumption of California walnuts, which are particularly rich in ALA, L-arginine and polyphenols, will improve endothelial function and platelet reactivity in an at-risk population of postmenopausal women 50-70 years of age.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Ragle Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Hormone replacement therapy
  • Alcohol consumption > 1 drink/day (i.e. 1 bottle of beer, ½ glass of wine, and 1 shot of hard liquor)
  • Fruit consumption ≥ 3 cups (6 servings)/day
  • Vegetable consumption ≥ 4 cups (8 servings)/day
  • Grain consumption ≥ 8 oz/day
  • Meat and Beans ≥ 7 oz/day
  • Fatty Fish ≥ 3 times/week
  • Milk ≥ 5 cups/day
  • Oil ≥ 8 tsp/day
  • Coffee/tea ≥ 3 cups/day
  • Dark chocolate ≥ 3 oz/day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 g of walnuts
Other: Walnuts
Consumption of 5 g of walnuts.
Other: Walnuts
Consumption of 20 g of walnuts.
Other: Walnuts
Consumption of 30 g of walnuts.
Other: Walnuts
Consumption of 40 g of walnuts.
Experimental: 20 g of walnuts
Other: Walnuts
Consumption of 5 g of walnuts.
Other: Walnuts
Consumption of 20 g of walnuts.
Other: Walnuts
Consumption of 30 g of walnuts.
Other: Walnuts
Consumption of 40 g of walnuts.
Experimental: 30 g of walnuts
Other: Walnuts
Consumption of 5 g of walnuts.
Other: Walnuts
Consumption of 20 g of walnuts.
Other: Walnuts
Consumption of 30 g of walnuts.
Other: Walnuts
Consumption of 40 g of walnuts.
Experimental: 40 g of walnuts
Other: Walnuts
Consumption of 5 g of walnuts.
Other: Walnuts
Consumption of 20 g of walnuts.
Other: Walnuts
Consumption of 30 g of walnuts.
Other: Walnuts
Consumption of 40 g of walnuts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Peripheral Arterial Tonometry (PAT)
Time Frame: 2 and 4 hours
2 and 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

California Walnut Commission

Investigators

  • Principal Investigator: Robert M. Hackman, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917508-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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