NCT01884363

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

June 19, 2013

Last Update Submit

March 16, 2016

Conditions

Coronary Heart DiseaseType 2 Diabetes

Keywords

Endothelial functionwalnutsclinical trialNutritioncardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention)

    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 Outcomes (1)

  • Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)

    12 weeks

Other Outcomes (1)

  • Change in heart rate variability between baseline and 12 weeks post-intervention

    12 weeks

Study Arms (2)

Walnuts

EXPERIMENTAL

This group will receive one ounce of walnuts per day

Other: Once ounce per day of walnuts

Usual diet (no walnuts)

NO INTERVENTION

Control group (does not receive walnuts in the diet)

Interventions

Once ounce per day of walnutsOTHER
Walnuts

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseDiabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Luc Djousse, MD, ScD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research, Associate Professor of Medicine

Study Record Dates

First Submitted

June 19, 2013

First Posted

June 24, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 18, 2016

Record last verified: 2016-03

Locations

US(1)