Walnut Consumption, Endothelial Function, and Biomarkers

March 16, 2016 updated by: Luc Djousse, Brigham and Women's Hospital

Walnut Consumption, Endothelial Function, and Plasma Adipokines in Subjects With Diabetes or Coronary Disease: a Pilot Trial

This study will examine whether a twelve-week intervention with one ounce (28 g) per day of walnuts improves endothelial function measured non-invasively using finger probe (EndoPat-2000) in people with coronary heart disease or type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 30+ years
  • Prevalent coronary artery disease
  • Prevalent type 2 diabetes

Exclusion Criteria:

  • Current eating disorder
  • Pregnant or lactating women
  • Allergy to walnuts or other nuts
  • Inability to provide informed consent or blood samples
  • History or prevalent diagnosis of cancer, asthma, kidney insufficiency, stroke, seizures, allergic disorders, or congestive heart failure
  • Diagnosis of coronary heart disease or diabetes < 1 year prior to enrollment
  • Intention to move out of greater Boston area within one year
  • Current use of walnuts for more than 2 ounces per day
  • Bleeding disorder
  • Treatment with blood thinning drugs (i.e. warfarin, clopidogrel)
  • Major surgical operation 3 months before or after screening
  • Organ transplantation
  • Current participation in another trial or plan to do so during the study
  • Use of vasodilators such as nitroglycerin
  • Inability to give informed consent
  • Inability to travel to the study center at Brigham and Women's Hospital

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walnuts
This group will receive one ounce of walnuts per day
Other: Once ounce per day of walnuts
No Intervention: Usual diet (no walnuts)
Control group (does not receive walnuts in the diet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)
Time Frame: 12 weeks
Reactive hyperemia index (RHI), which in part reflects vasodilator function of the small blood vessel at the fingertips is an indirect measure of endothelial function. Change in RHI between baseline and 12 weeks post intervention will be measured in each group using EndoPat2000 device. We will compare RHI change between walnut group and usual diet group.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)
Time Frame: 12 weeks
Specifically, we will measure changes in blood levels of following hormones: retinol binding protein 4, fatty acid binding protein 4, total adiponectin, and leptin before and after 12 weeks of walnut consumption/consumption of usual diet.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in heart rate variability between baseline and 12 weeks post-intervention
Time Frame: 12 weeks
Change in heart rate variability will be measured in each group before and after 12 weeks.
12 weeks

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Luc Djousse, MD, ScD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Djousse L, Lu B, Gaziano JM. Effects of Walnut Consumption on Endothelial Function in People with Type 2 Diabetes: a Randomized Pilot Trial. Curr Nutr Rep 2016;5:1-8

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, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P000803

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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