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DIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE


- candidate number29057
- NTR NumberNTR7315
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2018
- Secondary IDsNL64448.091.17 
- Public TitleDIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE
- Scientific TitleDIETARY NITRATE INTAKE IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE
- ACRONYMWalk-ON
- hypothesisInvestigate the acute effect of beetroot juice (BRJ) and high nitrate vegetables (HNV) vs. nitrate depleted beetroot juice (placebo (PL)) on exercise tolerance and vascular function in participants with diagnosed peripheral arterial disease.
- Healt Condition(s) or Problem(s) studiedPeripheral Arterial Disease, Intermittent claudication
- 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) <0.9 and/or an ABI decreased by more than 0.15 after treadmill testing regardless of their ABI at rest;
- Rutherford classification for chronic limb ischemia 1-4 and/or Fontaine classification stage IIA, IIB or III
- Exclusion criteriaA potential participant who meets any of the following criteria will be excluded from participation in this study:
- any condition other than PAD that limits walking;
- patients 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;
- using isosorbide dinitrate/mononitrate and/or contraindicated sildenafil, tadalafil, vardenafil .
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, randomized
- Studytype[default]
- planned startdate 1-jun-2018
- planned closingdate1-jun-2019
- Target number of participants18
- Interventions- placebo
- beetroot juice
- nitrate-rich vegetables
- Primary outcomemaximal walking distance
- Secondary outcome- PWV
- NIRS
- Dietary intake
- Timepoints-
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Cindy van der Avoort
- CONTACT for SCIENTIFIC QUERIES Maria Hopman
- Sponsor/Initiator Eat2Move
- Funding
(Source(s) of Monetary or Material Support)
Eat2Move
- Publications
- Brief summaryRationale: Dietary nitrate supplementation has been associated with several cardiovascular benefits such as a reduction in blood pressure [1, 2] and improved revascularization in chronic ischemia [3]. Whilst dietary nitrate has ergogenic effects in healthy individuals, these earlier findings of the benefits of dietary nitrate suggests that ergogenic effects may also apply to clinical settings, e.g., patients with peripheral arterial disease [4]. Yet, there is still very limited evidence in this patient population. Furthermore, the majority of studies has used beetroot juice as the nitrate carrier and it is unknown whether potential benefits could also be induced through other strategies such as increasing habitual nitrate intake through the diet.

Objective: The aim of the current study is to:
Investigate the acute effect of beetroot juice (BRJ) and high nitrate vegetables (HNV) vs. nitrate depleted beetroot juice (placebo (PL)) on exercise tolerance and vascular function in participants with diagnosed peripheral arterial disease.

Study design: randomized cross-over intervention study

Study population: 18 patients diagnosed with PAD.

Intervention: In a randomized cross-over manner, participants will follow an acute supplementation protocol in which they will eat a high nitrate meal in de form of vegetables and/or ingest 400 mg (6.5 mmol) nitrate in the form of concentrated red beetroot juice and/or placebo. Main study parameters/endpoints: The primary parameter will be exercise tolerance. Vascular function will be determined throughout the trials as secondary parameters. Tertiary parameters will be plasma nitrate and nitrite and dietary intake.
- Main changes (audit trail)
- RECORD19-jun-2018 - 8-jul-2018


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