Walnut Consumption, Endothelial Function, and Biomarkers

NCT ID: NCT01884363

Last Updated: 2016-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Heart Disease Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Walnuts

This group will receive one ounce of walnuts per day

Group Type EXPERIMENTAL

Once ounce per day of walnuts

Intervention Type OTHER

Usual diet (no walnuts)

Control group (does not receive walnuts in the diet)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Once ounce per day of walnuts

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luc Djousse

Director of Research, Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Djousse, MD, ScD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

Other Identifiers

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2013P000803

Identifier Type: -

Identifier Source: org_study_id

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