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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
California Walnut Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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