Peripheral Arterial Disease Clinical Trial
Official title:
Exploring the Health Benefits Associated With Daily Pulse Consumption in Individuals With Peripheral Arterial Disease
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.
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:
1. Screening Visit: Informed consent; inclusion/exclusion criteria assessment; medical
history; physical exam; food frequency questionnaire; 3-day food record
2. 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
3. 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
4. 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
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Completed |
NCT02384980 -
Saving Life and Limb: FES for the Elderly With PAD
|
Phase 1 |