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Completed

NCT Number: NCT01884363

Walnut Consumption, Endothelial Function, and Biomarkers

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Type 2 Diabetes Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Once ounce per day of walnuts

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2013
Registry last updated
Mar 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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