Peripheral Arterial DiseaseEarly Phase 1NCT00755677
Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
A Early Phase 1 study testing Pulses in people with Peripheral Arterial Disease, run by St. Boniface Hospital at 1 site in Canada.
Trial summary
This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with peripheral arterial disease. Read more about this study
- Who is it for?
- Ages 40 to 82 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Pulses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Jul 2008
- Phase
- Early Phase 1
- 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 40 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 and asymptomatic carotid stenosis lesion of > 50%
- Male or female (> 40 years of age)
- Willing to comply with the protocol requirements
- Willing to provide informed consent
- Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks)
Who cannot join
- Renal failure requiring dialysis
- Currently smoking
- Hormone replacement therapy
- Inability to adhere to a regular diet
- Additional intake of pulses outside the planned daily requirements outlined in the study
- History of gastrointestinal reactions or allergies to pulses
Trial locations and contacts
1 site in 1 country.
About this study
This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with peripheral arterial disease. The investigators hypothesis that a diet containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day provides flavonoid compounds that improve cardiovascular health by increasing the levels of serum adiponectin is based on evidence from the literature that indicates flavonoids present in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.
Read the detailed description
Objectives:
- Correlate serum adiponectin levels with daily intake of pulses in individuals with peripheral arterial disease
- Monitor changes in arterial stiffness and endothelial dysfunction in individuals with early stage cardiovascular disease
- Determine the tolerability of daily consumption of pulses in the targeted population
- Identify changes in the expression profile of white blood cells.
Study Duration: 12 months
Study Design:
- This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with arterial disease
- Each subject will undergo a 7-day adaptation period consisting of a consumption of ¼ cup of pulses per serving daily, followed by a minimum of ½ cup of pulses per serving daily
- Total duration of subject participation is 8 weeks;
- Subjects will be asked to attend 3 in-person clinic visits over the duration of their participation in the study for screening, registration/baseline and end of study assessments
- Telephone follow-up to subjects will occur at weeks 1,2,4, and 6
- Both clinical assessment and subject-based data will be collected at various points of the study schedule
- Subjects will be asked to complete a food frequency questionnaire at the outset, maintain a 3-day food record at two separate occasions, and undergo a brief semi-structured interview during the telephone follow-up assessments of the study
Assessments:
- Screening Visit: Informed consent; inclusion/exclusion criteria assessment; medical history; physical exam; food frequency questionnaire; 3-day food record
- Registration/Baseline: Registration; assess for changes to medical history (including medication profile) and physical condition; urine sample; fasting blood sample; assessment of arterial stiffness and ankle-brachial index; begin adaptation period (7 days)with food items containing ¼ c of pulses per serving
- Visits 1,2,4 \& 6: Telephone follow-up to assess adverse events and tolerability with semi-structured subject interview; distribution (weekly) of food items containing a minimum of ½ cup pulses per serving; 3-day food record repeated at week 6
- Visit 8 (final): Assess for adverse events and changes to medical history and physical exam; urine sample; fasting blood sample collection; assessment of arterial stiffness and and ankle-brachial index
Outcomes:
- Descriptive analysis of clinical data: Demographics, medical history, physical findings, concomitant medications and adverse events
- Identification of changes in endothelial function (determined by measuring pulse wave velocity (PWV), ankle-brachial index, soluble adhesion molecule levels and coagulation status) in response to dietary modification
- Correlation of serum adiponectin levels, including adiponectin multimers and truncated form (globular adiponectin) with endothelial function
- Correlation of changes in endothelial cell function with serum isoflavone levels
- Qualitative analysis of data collected from semi-structured subject interviews to assess parameters associated with tolerability of diet and to identify favoured recipes
- Profile cohort using 55,000 gene microarray to identify potential biomarkers and changes in gene expression (phenotype mapping) induced by diet
- Use microarrays to examine gene methylation and single nucleotide polymorphisms (SNP) in DNA samples to determine if changes in expression profile are due to epigenetic modification (global) or allelic (individual) variation in the study cohort in response to a pulse-enriched diet
- Serum and urinary eicosanoids will be analyzed by a multi-step procedure utilizing liquid chromatography, derivitization steps, thin-layer chromatography and gas chromatography-mass spectrometry
- Serum will also be analyzed for fatty acid composition using thin-layer chromatography and gas chromatography
- Conditions
- Peripheral Arterial Disease
- Being tested
- Pulses
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulsesOther
subjects consume 1 pulse food daily for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| pulses | Other | Interventional. Participants are registered sequentially to undergo daily consumption of pulses for eight weeks Receives: Other: Pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of changes in endothelial function in response to dietary modification
Measured: baseline, week 8
Correlation of serum adiponectin levels
Measured: baseline, week 8
Correlation of changes in endothelial cell function with serum isoflavone levels
Measured: baseline, week 8
Genetic Profiling
Measured: baseline, week 8
Analysis of serum and urinary eicosanoids
Measured: baseline, week 8
Serum analysis for fatty acid composition
Measured: baseline, week 8
Secondary outcomes (4)
Descriptive analysis of clinical data: Demographics, medical history,
Measured: baseline
Physical findings, concomitant medications and adverse events
Measured: baseline, weekly for 8 weeks
Qualitative analysis of data collected from semi-structured subject interviews
Measured: week 1, week 2, week 4, week 6, week 8
(Compliance/tolerability/side effects)
Measured: week 1, week 2, week 4, week 6, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startMar 2007
- Primary completionJan 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (108)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Principal investigator, Dr.Peter Zahradka, St. Boniface Hospital
- Investigators
- Peter Zahradka, PhD, Principal investigator, St. Boniface Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755677
- Sponsor's protocol ID
- Pulse Study
- Status last verified
- Mar 2012
- First submitted
- 11 Sep 2008
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
PubMed 12196085Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
PubMed 16489846Juvenile Diabetes Research Foundation (2005) http://www jdrf org au/publications/factsheets/complications html
Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
PubMed 16449729British Heart Foundation Statistics (2006) www heartstats org
Houston DK, Stevens J, Cai J, Haines PS. Dairy, fruit, and vegetable intakes and functional limitations and disability in a biracial cohort: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 2005 Feb;81(2):515-22. doi: 10.1093/ajcn.81.2.515.
PubMed 15699243Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. doi: 10.1001/jama.288.20.2569.
PubMed 12444864Bazzano LA, Serdula MK, Liu S. Dietary intake of fruits and vegetables and risk of cardiovascular disease. Curr Atheroscler Rep. 2003 Nov;5(6):492-9. doi: 10.1007/s11883-003-0040-z.
PubMed 14525683Anderson JW, Major AW. Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. Br J Nutr. 2002 Dec;88 Suppl 3:S263-71. doi: 10.1079/BJN2002716.
PubMed 12498626Castro IA, Barroso LP, Sinnecker P. Functional foods for coronary heart disease risk reduction: a meta-analysis using a multivariate approach. Am J Clin Nutr. 2005 Jul;82(1):32-40. doi: 10.1093/ajcn.82.1.32.
PubMed 16002797Rowland I. Optimal nutrition: fibre and phytochemicals. Proc Nutr Soc. 1999 May;58(2):415-9. doi: 10.1017/s0029665199000543.
PubMed 10466185Gylling H, Miettinen TA. The effect of plant stanol- and sterol-enriched foods on lipid metabolism, serum lipids and coronary heart disease. Ann Clin Biochem. 2005 Jul;42(Pt 4):254-63. doi: 10.1258/0004563054255605.
PubMed 15989725Hertog MG, Feskens EJ, Hollman PC, Katan MB, Kromhout D. Dietary antioxidant flavonoids and risk of coronary heart disease: the Zutphen Elderly Study. Lancet. 1993 Oct 23;342(8878):1007-11. doi: 10.1016/0140-6736(93)92876-u.
PubMed 8105262Keli SO, Hertog MG, Feskens EJ, Kromhout D. Dietary flavonoids, antioxidant vitamins, and incidence of stroke: the Zutphen study. Arch Intern Med. 1996 Mar 25;156(6):637-42.
PubMed 8629875Wylie-Rosett J, Segal-Isaacson CJ, Segal-Isaacson A. Carbohydrates and increases in obesity: does the type of carbohydrate make a difference? Obes Res. 2004 Nov;12 Suppl 2:124S-9S. doi: 10.1038/oby.2004.277.
PubMed 15601960
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT00755677
- Acronym / sponsor ID
- Pulse Study
- Conditions
- Peripheral Arterial Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- Mar 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Sep 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 single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with peripheral arterial disease. The investigators hypothesis that a diet containing at least one serving of pulse crops (dried beans, peas, lentil, chickpeas) per day provides flavonoid compounds that improve cardiovascular health by increasing the levels of serum adiponectin is based on evidence from the literature that indicates flavonoids present in these foods are capable of improving arterial stiffness and reducing hypercholesterolemia.
Detailed description
Objectives:
- Correlate serum adiponectin levels with daily intake of pulses in individuals with peripheral arterial disease
- Monitor changes in arterial stiffness and endothelial dysfunction in individuals with early stage cardiovascular disease
- Determine the tolerability of daily consumption of pulses in the targeted population
- Identify changes in the expression profile of white blood cells.
Study Duration: 12 months
Study Design:
- This is a single site, open registration, dietary proof of concept, food substance study designed to explore the health benefits associated with daily pulse consumption in individuals with arterial disease
- Each subject will undergo a 7-day adaptation period consisting of a consumption of ¼ cup of pulses per serving daily, followed by a minimum of ½ cup of pulses per serving daily
- Total duration of subject participation is 8 weeks;
- Subjects will be asked to attend 3 in-person clinic visits over the duration of their participation in the study for screening, registration/baseline and end of study assessments
- Telephone follow-up to subjects will occur at weeks 1,2,4, and 6
- Both clinical assessment and subject-based data will be collected at various points of the study schedule
- Subjects will be asked to complete a food frequency questionnaire at the outset, maintain a 3-day food record at two separate occasions, and undergo a brief semi-structured interview during the telephone follow-up assessments of the study
Assessments:
- Screening Visit: Informed consent; inclusion/exclusion criteria assessment; medical history; physical exam; food frequency questionnaire; 3-day food record
- Registration/Baseline: Registration; assess for changes to medical history (including medication profile) and physical condition; urine sample; fasting blood sample; assessment of arterial stiffness and ankle-brachial index; begin adaptation period (7 days)with food items containing ¼ c of pulses per serving
- Visits 1,2,4 \& 6: Telephone follow-up to assess adverse events and tolerability with semi-structured subject interview; distribution (weekly) of food items containing a minimum of ½ cup pulses per serving; 3-day food record repeated at week 6
- Visit 8 (final): Assess for adverse events and changes to medical history and physical exam; urine sample; fasting blood sample collection; assessment of arterial stiffness and and ankle-brachial index
Outcomes:
- Descriptive analysis of clinical data: Demographics, medical history, physical findings, concomitant medications and adverse events
- Identification of changes in endothelial function (determined by measuring pulse wave velocity (PWV), ankle-brachial index, soluble adhesion molecule levels and coagulation status) in response to dietary modification
- Correlation of serum adiponectin levels, including adiponectin multimers and truncated form (globular adiponectin) with endothelial function
- Correlation of changes in endothelial cell function with serum isoflavone levels
- Qualitative analysis of data collected from semi-structured subject interviews to assess parameters associated with tolerability of diet and to identify favoured recipes
- Profile cohort using 55,000 gene microarray to identify potential biomarkers and changes in gene expression (phenotype mapping) induced by diet
- Use microarrays to examine gene methylation and single nucleotide polymorphisms (SNP) in DNA samples to determine if changes in expression profile are due to epigenetic modification (global) or allelic (individual) variation in the study cohort in response to a pulse-enriched diet
- Serum and urinary eicosanoids will be analyzed by a multi-step procedure utilizing liquid chromatography, derivitization steps, thin-layer chromatography and gas chromatography-mass spectrometry
- Serum will also be analyzed for fatty acid composition using thin-layer chromatography and gas chromatography
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulses | Other | Other: PulsesInterventional. Participants are registered sequentially to undergo daily consumption of pulses for eight weeks |
Who may qualify
- Ages
- 40 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 and asymptomatic carotid stenosis lesion of > 50%
- Male or female (> 40 years of age)
- Willing to comply with the protocol requirements
- Willing to provide informed consent
- Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks)
Key exclusion criteria (6 listed)
- Renal failure requiring dialysis
- Currently smoking
- Hormone replacement therapy
- Inability to adhere to a regular diet
- Additional intake of pulses outside the planned daily requirements outlined in 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 |
|---|---|---|
| Pulsessubjects consume 1 pulse food daily for eight weeks | Other | pulses |
Primary outcome
Identification of changes in endothelial function in response to dietary modification
Time frame: baseline, week 8
Correlation of serum adiponectin levels
Time frame: baseline, week 8
Correlation of changes in endothelial cell function with serum isoflavone levels
Time frame: baseline, week 8
Genetic Profiling
Time frame: baseline, week 8
Analysis of serum and urinary eicosanoids
Time frame: baseline, week 8
Serum analysis for fatty acid composition
Time frame: baseline, week 8
4 secondary outcomes
Descriptive analysis of clinical data: Demographics, medical history,
Time frame: baseline
Physical findings, concomitant medications and adverse events
Time frame: baseline, weekly for 8 weeks
Qualitative analysis of data collected from semi-structured subject interviews
Time frame: week 1, week 2, week 4, week 6, week 8
(Compliance/tolerability/side effects)
Time frame: week 1, week 2, week 4, week 6, week 8
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 21 Mar 2012.
- Background: PubMed 12196085Wilson PW, D'Agostino RB, Sullivan L, Parise H, Kannel WB. Overweight and obesity as determinants of cardiovascular risk: the Framingham experience. Arch Intern Med. 2002 Sep 9;162(16):1867-72. doi: 10.1001/archinte.162.16.1867.
- Background: PubMed 16489846Calkin AC, Allen TJ. Diabetes mellitus-associated atherosclerosis: mechanisms involved and potential for pharmacological invention. Am J Cardiovasc Drugs. 2006;6(1):15-40. doi: 10.2165/00129784-200606010-00003.
- BackgroundJuvenile Diabetes Research Foundation (2005) http://www jdrf org au/publications/factsheets/complications html
- Background: PubMed 16449729Li TY, Rana JS, Manson JE, Willett WC, Stampfer MJ, Colditz GA, Rexrode KM, Hu FB. Obesity as compared with physical activity in predicting risk of coronary heart disease in women. Circulation. 2006 Jan 31;113(4):499-506. doi: 10.1161/CIRCULATIONAHA.105.574087.
- BackgroundBritish Heart Foundation Statistics (2006) www heartstats org
- Background: PubMed 15699243Houston DK, Stevens J, Cai J, Haines PS. Dairy, fruit, and vegetable intakes and functional limitations and disability in a biracial cohort: the Atherosclerosis Risk in Communities Study. Am J Clin Nutr. 2005 Feb;81(2):515-22. doi: 10.1093/ajcn.81.2.515.
- Background: PubMed 12444864Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. doi: 10.1001/jama.288.20.2569.
- Background: PubMed 14525683Bazzano LA, Serdula MK, Liu S. Dietary intake of fruits and vegetables and risk of cardiovascular disease. Curr Atheroscler Rep. 2003 Nov;5(6):492-9. doi: 10.1007/s11883-003-0040-z.
- Background: PubMed 12498626Anderson JW, Major AW. Pulses and lipaemia, short- and long-term effect: potential in the prevention of cardiovascular disease. Br J Nutr. 2002 Dec;88 Suppl 3:S263-71. doi: 10.1079/BJN2002716.
- Background: PubMed 16002797Castro IA, Barroso LP, Sinnecker P. Functional foods for coronary heart disease risk reduction: a meta-analysis using a multivariate approach. Am J Clin Nutr. 2005 Jul;82(1):32-40. doi: 10.1093/ajcn.82.1.32.
- Background: PubMed 10466185Rowland I. Optimal nutrition: fibre and phytochemicals. Proc Nutr Soc. 1999 May;58(2):415-9. doi: 10.1017/s0029665199000543.
- Background: PubMed 15989725Gylling H, Miettinen TA. The effect of plant stanol- and sterol-enriched foods on lipid metabolism, serum lipids and coronary heart disease. Ann Clin Biochem. 2005 Jul;42(Pt 4):254-63. doi: 10.1258/0004563054255605.
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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.
Peter Zahradka, PhD principal investigator
St. Boniface Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pulses in people with Peripheral Arterial Disease, run by St. Boniface Hospital at 1 site in Canada.
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 21 Mar 2012. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Identification of changes in endothelial function in response to dietary modification (time frame: baseline, week 8). The study lists 6 primary outcomes in all. 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 NCT00755677, which also lists 108 linked publications.
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 21 Mar 2012.