Coronary Artery DiseaseNCT01038362
Effects of Almonds On Endothelial Function In Patients With Coronary Artery Disease
A study testing NCEP Step 1 diet plus Almonds and No Almonds in people with Coronary Artery Disease, run by Boston University at 1 site in United States.
Trial summary
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- NCEP Step 1 diet plus Almonds and No Almonds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2009
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female subjects.
- Age range: 21-80 years old.
- Weight less than 115 kg.
- Clinically defined coronary artery disease that is clinical stable and compensated with appropriate treatment. Coronary disease (CVD) is defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
- Willingness to give written informed consent and willingness and ability to understand, to participate to and to comply with the study requirements.
Who cannot join
- History of nut allergy.
- Pregnant or lactating women. Pregnancy will be excluded by urine pregnancy test.
- 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.
- Treatment with an investigational new drug within the last 30 days.
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- Unwillingness to comply with the requirements of study including refraining from consumption of nuts and refraining from use of Vitamin E, vitamin C, and beta carotene, lipoic acid, and/or other dietary or herbal supplements during the study.
Trial locations and contacts
1 site in 1 country.
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
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. In patients with atherosclerosis, these functions of the endothelium are impaired and these abnormalities may contribute to the development of heart attack and stroke.
Observational studies have shown that frequent nut consumption decreases the risk of cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined. Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable effects on cardiovascular disease. In addition, there is growing evidence that these compounds may improve the function of the endothelium.
Read more
The present study is designed to test the hypothesis that an almond-enriched diet will improve the function of the endothelium in patients with coronary artery disease. Subjects will be enrolled into a randomized, placebo-controlled, crossover study that will compare a National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the same number of total calories but includes 3 ounces of almonds daily. Participants will consume each diet for six weeks with a four-week rest period between diets. The order of diets will be randomized (almonds or no almonds). Dietary assessments via food recall questionnaires will be employed at the study entry, end of the four week washout period, and end of the second intervention. If subjects are drifting from the recommendations of the STEP 1 diet, counseling will be given to urge compliance. The primary endpoint will be endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study outcomes will include lipid profiles, markers of inflammation and oxidative stress. Enrollment will continue until 40 subjects with complete data are available.
Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood collection will be performed in the principal investigator's research unit at Boston Medical Center.
- Conditions
- Coronary Artery Disease
- Being tested
- NCEP Step 1 diet plus Almonds, No Almonds
- Keywords
- endothelium, almonds, dietary interventions, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCEP Step 1 diet plus AlmondsOther
NCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks
No AlmondsOther
NCEP Step 1 diet without almonds
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Active comparator | National Cholesterol Education Program Step I diet plus almonds for 6 weeks Receives: Other: NCEP Step 1 diet plus Almonds |
| No Almonds | Placebo comparator | National Cholesterol Education Program Step 1 diet without almonds for 6 weeks Receives: Other: No Almonds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery flow-mediated dilation
Measured: 6 weeks
Secondary outcomes (1)
Blood markers of inflammation, dyslipidemia, and oxidative stress
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University
- Investigators
- Joseph A Vita, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038362
- Sponsor's protocol ID
- H-27411
- Status last verified
- Dec 2009
- First submitted
- 19 Dec 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. 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
- NCT01038362
- Acronym / sponsor ID
- H-27411
- Conditions
- Coronary Artery Disease
- Keywords
- endothelium, almonds, dietary interventions, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Tufts University
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Dec 2009 (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.
The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by production of a variety of regulatory substances, including nitric oxide. In patients with atherosclerosis, these functions of the endothelium are impaired and these abnormalities may contribute to the development of heart attack and stroke.
Observational studies have shown that frequent nut consumption decreases the risk of cardiovascular disease (CVD), but the mechanisms of benefit have not been fully defined. Recent studies suggest that specific fatty acids and flavonoids in nuts may have favorable effects on cardiovascular disease. In addition, there is growing evidence that these compounds may improve the function of the endothelium.
The present study is designed to test the hypothesis that an almond-enriched diet will improve the function of the endothelium in patients with coronary artery disease. Subjects will be enrolled into a randomized, placebo-controlled, crossover study that will compare a National Cholesterol Education Program Step 1 diet without nuts to a Step 1 diet that has the same number of total calories but includes 3 ounces of almonds daily. Participants will consume each diet for six weeks with a four-week rest period between diets. The order of diets will be randomized (almonds or no almonds). Dietary assessments via food recall questionnaires will be employed at the study entry, end of the four week washout period, and end of the second intervention. If subjects are drifting from the recommendations of the STEP 1 diet, counseling will be given to urge compliance. The primary endpoint will be endothelium-dependent flow- mediated dilation assessed by ultrasound. Secondary study outcomes will include lipid profiles, markers of inflammation and oxidative stress. Enrollment will continue until 40 subjects with complete data are available.
Patients will be enrolled at Boston Medical Center and the Jean Mayer US Department of Agriculture Human Nutrition Research Center at Tufts Medical Center. Dietary interventions will be performed at Tufts Medical Center or by telephone. Ultrasound studies and blood collection will be performed in the principal investigator's research unit at Boston Medical Center.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonds | Active comparator | Other: NCEP Step 1 diet plus AlmondsNational Cholesterol Education Program Step I diet plus almonds for 6 weeks |
| No Almonds | Placebo comparator | Other: No AlmondsNational Cholesterol Education Program Step 1 diet without almonds for 6 weeks |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and Female subjects.
- Age range: 21-80 years old.
- Weight less than 115 kg.
- Clinically defined coronary artery disease that is clinical stable and compensated with appropriate treatment. Coronary disease (CVD) is defined by the presence of lesions on coronary angiography, history of myocardial infarction, or positive stress test.
- Willingness to give written informed consent and willingness and ability to understand, to participate to and to comply with the study requirements.
Key exclusion criteria (6 listed)
- History of nut allergy.
- Pregnant or lactating women. Pregnancy will be excluded by urine pregnancy test.
- 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.
- Treatment with an investigational new drug within the last 30 days.
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
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 |
|---|---|---|
| NCEP Step 1 diet plus AlmondsNCEP Step 1 Diet Plus Almonds 3 oz per day for 6 weeks | Other | Almonds |
| No AlmondsNCEP Step 1 diet without almonds | Other | No Almonds |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: 6 weeks
1 secondary outcome
Blood markers of inflammation, dyslipidemia, and oxidative stress
Time frame: 6 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 23 Dec 2009.
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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.
Joseph A 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 NCEP Step 1 diet plus Almonds and No Almonds in people with Coronary Artery Disease, run by Boston 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 5 inclusion and 6 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 23 Dec 2009. 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?
Brachial artery flow-mediated dilation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2009.