Vascular DiseaseNCT00782015
Effects of Almonds on Vascular Reactivity in Patients With Coronary Artery Disease
A study testing Almonds in people with Vascular Disease and Endothelial Dysfunction, run by Tufts University at 1 site in United States.
Trial summary
This is a study of the effects of 3 oz almonds added daily to a National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function in patients with Coronary Artery Disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Vascular Disease, Endothelial Dysfunction, Heart Disease
- What is being tested?
- Almonds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2011
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable CAD Patients (men \& postmenopausal women)
- aged 20-80 years
- weighing less than 115 Kg (BMI range 18.5-35 kg/m2)
- with coronary artery disease defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
- Subjects are eligible to participate after a stent procedure only after they have been stable for one month after the stent procedure.
- All Ethnic Groups.
- Languages: English
Who cannot join
- Subjects with heart failure are not eligible for participation in this study.
- History or known allergy to nuts of any kind
- Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
- Regular use of oral steroids
Show all 15Show fewer
- Cigarette smoking and/or nicotine replacement use
- Regular daily intake of ≥ 2 alcoholic drinks
- Illicit drug use
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
- Treatment with an investigational new drug within the last 30 days.
- Treatment with Vitamin E, Vitamin C, beta carotene, lipoic acid, or other food or herbal supplements within 1 month of enrollment (subjects taking multivitamins or other forms of vitamin E and C in doses that do not exceed two times the RDA will not be excluded).
- The following medications will be withheld in the morning of each ultrasound study visit as follows:
- All vasoactive medications (nitrates, calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors, and other vasodilators). Subjects will take their medications immediately after the ultrasound measurements are taken.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (HNRCA)
Boston, Massachusetts, 02111
About this study
Official title: Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease
This is a study of the effects of 3 oz almonds added daily to a National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function in patients with Coronary Artery Disease. The study seeks to determine if these effects are mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and systemic inflammation.
Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia, inflammation, endothelial function, vascular reactivity and oxidative stress.
Read the detailed description
The study is a randomized, crossover, 6 week intervention trial design with a 6 week run in on the TLC diet and a 6 week washout on the TLC diet between control and intervention periods. Forty subjects with verified and stable coronary artery disease will be enrolled in the study. The control intervention involved maintaining a steady TLC diet without nuts which will be monitored with counseling and dietary assessments. The almond intervention involved consuming 3 oz. of almonds per day and adjusting lipid intake to remain isocaloric with the TLC diet alone. Again subjects will be monitored with counseling and dietary assessments.
At the beginning and end of each intervention period subjects will be tested for endothelial function using flow mediated dilation and blood and urine samples will be collected for biochemical analysis for markers of inflammation, dyslipidemia, and oxidative stress.
- Conditions
- Vascular Disease, Endothelial Dysfunction, Heart Disease, Cardiovascular Diseases, Hypertension
- Being tested
- Almonds, Placebo Comparator:
- Keywords
- almonds, heart disease, vascular reactivity, inflammation, dyslipidemia, oxidative stress
- Medical subject headings
- Vascular Diseases, Heart Diseases, Cardiovascular Diseases, Hypertension, Inflammation, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
Also called Nuts
3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks.
Placebo Comparator:Dietary supplement
NCEP Step 2 diet
| Study group | Role | What they receive |
|---|---|---|
| almonds | Active comparator | 3 oz/d almonds Receives: Dietary Supplement: Almonds |
| Placebo | Placebo comparator | NCEP Step 2 diet Receives: Dietary Supplement: Placebo Comparator: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function.
Measured: After 6 weeks eating almonds
Secondary outcomes (3)
Biochemical markers of inflammation, such as cytokines
Measured: After 6 weeks of eating almonds
Biochemical markers of dyslipidemia, such as lipid profiles
Measured: After 6 weeks of eating almonds
Biomarkers of oxidative stress, such as isoprostanes and 8OHdG
Measured: After 6 weeks of eating almonds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2011
- Study completionJan 2011
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 Vascular DiseaseStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Jeffrey Blumberg, Tufts University
- Investigators
- Jeffrey B Blumberg, PhD, Principal investigator, HNRCA Tufts UniversityJoseph Vita, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782015
- Sponsor's protocol ID
- TuftsIRB8723
- Status last verified
- Apr 2017
- First submitted
- 28 Oct 2008
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen CY, Holbrook M, Duess MA, Dohadwala MM, Hamburg NM, Asztalos BF, Milbury PE, Blumberg JB, Vita JA. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial. Nutr J. 2015 Jun 17;14:61. doi: 10.1186/s12937-015-0049-5.
PubMed 26080804
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almonds on Vascular Reactivity and Biomarkers of Inflammation, Oxidative Stress and Endothelial Function in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00782015
- Acronym / sponsor ID
- TuftsIRB8723
- Conditions
- Vascular Disease, Endothelial Dysfunction, Heart Disease, Cardiovascular Diseases, Hypertension
- Keywords
- almonds, heart disease, vascular reactivity, inflammation, dyslipidemia, oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- Oct 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 29 Oct 2008 (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 is a study of the effects of 3 oz almonds added daily to a National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet in improving endothelial function in patients with Coronary Artery Disease. The study seeks to determine if these effects are mediated via an increase in Nitric Oxide synthesis and reductions in dyslipidemia and systemic inflammation.
Vascular reactivity will be assessed via flow mediated dilation with endothelium-independent and hyperemic flow measured in the right brachial artery by non-invasive 2-dimensional and Doppler ultrasound. Serum will be collected and analyzed for biomarkers of dyslipidemia, inflammation, endothelial function, vascular reactivity and oxidative stress.
Detailed description
The study is a randomized, crossover, 6 week intervention trial design with a 6 week run in on the TLC diet and a 6 week washout on the TLC diet between control and intervention periods. Forty subjects with verified and stable coronary artery disease will be enrolled in the study. The control intervention involved maintaining a steady TLC diet without nuts which will be monitored with counseling and dietary assessments. The almond intervention involved consuming 3 oz. of almonds per day and adjusting lipid intake to remain isocaloric with the TLC diet alone. Again subjects will be monitored with counseling and dietary assessments.
At the beginning and end of each intervention period subjects will be tested for endothelial function using flow mediated dilation and blood and urine samples will be collected for biochemical analysis for markers of inflammation, dyslipidemia, and oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| almonds | Active comparator | Dietary Supplement: Almonds3 oz/d almonds |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Comparator:NCEP Step 2 diet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stable CAD Patients (men \& postmenopausal women)
- aged 20-80 years
- weighing less than 115 Kg (BMI range 18.5-35 kg/m2)
- with coronary artery disease defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
- Subjects are eligible to participate after a stent procedure only after they have been stable for one month after the stent procedure.
Key exclusion criteria (15 listed)
- Subjects with heart failure are not eligible for participation in this study.
- History or known allergy to nuts of any kind
- Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
- Regular consumption of ≥ 5 oz nuts/week for 6 weeks prior to study admission
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
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 |
|---|---|---|
| AlmondsAlso: Nuts3 oz. of almonds per day, supplied as 1 oz. snack packs to be consumed for 6 weeks. | Dietary supplement | almonds |
| Placebo Comparator:NCEP Step 2 diet | Dietary supplement | Placebo |
Primary outcome
Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function.
Time frame: After 6 weeks eating almonds
3 secondary outcomes
Biochemical markers of inflammation, such as cytokines
Time frame: After 6 weeks of eating almonds
Biochemical markers of dyslipidemia, such as lipid profiles
Time frame: After 6 weeks of eating almonds
Biomarkers of oxidative stress, such as isoprostanes and 8OHdG
Time frame: After 6 weeks of eating almonds
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 28 Apr 2017.
- Derived from this study: PubMed 26080804Chen CY, Holbrook M, Duess MA, Dohadwala MM, Hamburg NM, Asztalos BF, Milbury PE, Blumberg JB, Vita JA. Effect of almond consumption on vascular function in patients with coronary artery disease: a randomized, controlled, cross-over trial. Nutr J. 2015 Jun 17;14:61. doi: 10.1186/s12937-015-0049-5.
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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.
Jeffrey B Blumberg, PhD principal investigator
HNRCA Tufts University
Joseph Vita, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds in people with Vascular Disease and Endothelial Dysfunction, run by Tufts University 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 7 inclusion and 15 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 28 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
Endothelial Function as determined by flow mediated dilation and and biochemical markers of endothelial function. (time frame: After 6 weeks eating almonds). 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 NCT00782015, 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 28 Apr 2017.