Coronary Heart DiseaseNCT01884363
Walnut Consumption, Endothelial Function, and Biomarkers
A study testing Once ounce per day of walnuts in people with Coronary Heart Disease and Type 2 Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Heart Disease, Type 2 Diabetes
- What is being tested?
- Once ounce per day of walnuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30+ years
- Prevalent coronary artery disease
- Prevalent type 2 diabetes
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: 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.
- Conditions
- Coronary Heart Disease, Type 2 Diabetes
- Being tested
- Once ounce per day of walnuts
- Keywords
- Endothelial function, walnuts, clinical trial, Nutrition, cardiovascular disease
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once ounce per day of walnutsOther
| Study group | Role | What they receive |
|---|---|---|
| Walnuts | Experimental | This group will receive one ounce of walnuts per day Receives: Other: Once ounce per day of walnuts |
| Usual diet (no walnuts) | No intervention | Control group (does not receive walnuts in the diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Djousse, Brigham and Women's Hospital
- Investigators
- Luc Djousse, MD, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884363
- Sponsor's protocol ID
- 2013P000803
- Status last verified
- Mar 2016
- First submitted
- 19 Jun 2013
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walnut Consumption, Endothelial Function, and Plasma Adipokines in Subjects With Diabetes or Coronary Disease: a Pilot Trial
- ClinicalTrials.gov ID
- NCT01884363
- Acronym / sponsor ID
- 2013P000803
- Conditions
- Coronary Heart Disease, Type 2 Diabetes
- Keywords
- Endothelial function, walnuts, clinical trial, Nutrition, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walnuts | Experimental | Other: Once ounce per day of walnutsThis group will receive one ounce of walnuts per day |
| Usual diet (no walnuts) | No intervention | –Control group (does not receive walnuts in the diet) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30+ years
- Prevalent coronary artery disease
- Prevalent type 2 diabetes
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Once ounce per day of walnuts | Other | Walnuts |
Primary outcome
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.
1 secondary outcome
Change in blood levels of hormones produced by fat cells between baseline and 12 weeks (end of intervention)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- BackgroundDjousse 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Djousse, MD, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Once ounce per day of walnuts in people with Coronary Heart Disease and Type 2 Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reactive hyperemia index occurring between baseline and 12 weeks (end of intervention) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2016.