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DIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE

DIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE - Walk-ON

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46719
Enrollment
21
Registered
2018-05-24
Start date
2018-06-29
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perifeer Arterieel vaatlijden (vaataandoeningen) claudication

Interventions

In a randomized cross-over manner, participants will follow an acute supplementation protocol in which they will a high nitrate meal in de form of vegetables and/or ingest 400 mg (6.5 mmol) nitrate

Sponsors

Radboud Universiteit Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - stable intermittent claudication for at least three month; - ABI (the ratio of BP in the lower legs to the BP in the arms)

Exclusion criteria

Exclusion criteria: - any condition other than PAD that limits walking; - patients diagnosed with diagnosed with chronic kidney disease and/or or patients with insulin dependent diabetes; - previous endovascular or surgical treatment for claudication within the last 12 months - individuals with critical limb ischemia, who are wheel-chair bound, or who have an above or below-knee amputation; - using dietary nitrate supplements;

Design outcomes

Primary

MeasureTime frame
The primary parameter will be exercise tolerance, measured as peak walking time

Secondary

MeasureTime frame
Exercise tolerance: * Claudication onset time (COT) and distance (COD) * VO2 Vascular function: * Flow mediated dilation (FMD) * Blood pressure (BP) and heart rate (HR) * Tissue oxygenation (NIRS) Nitrate and nitrite: * Plasma nitrate and nitrite concentrations * Dietary intake

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)