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Beneficial effect of beetroot or spinaze consumption in mitochondrial myopathy patients.


- candidate number11189
- NTR NumberNTR3321
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-feb-2012
- Secondary IDsNL36927.015.11 CCMO
- Public TitleBeneficial effect of beetroot or spinaze consumption in mitochondrial myopathy patients.
- Scientific TitleTherapeutic effect of dietary inorganic nitrate supplementation in mitochondrial myopathy patients.
- ACRONYM
- hypothesisDietary inorganic nitrate supplementation will decrease O2 cost of exercise in patients with mitochondrial myopathy.
- Healt Condition(s) or Problem(s) studiedMitochondrial myopathy
- Inclusion criteria1. Diagnosis mitochondrial myopathy;
2. Age 18+.
- Exclusion criteria1. Pacemaker / ICS or other contra indication for MRI;
2. Claustrophobia;
3. Use of beta blocker therapy;
4. Use of oral anti-coagulants;
5. Use of aspirine NSAID's;
6. Use of calcium antagonists;
7. Use of inorganic nitrate;
8. Cardio-vascular disease;
9. Cerebro-vascular complications;
10. Neurological diseases of deficits;
11. Vascular complications.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-mrt-2012
- planned closingdate1-sep-2012
- Target number of participants10
- Interventions8 days dietary inorganic nitrate supplementation (sodium nitrate 8.5mg/kg body wt/day dissolved in 250 ml water).
- Primary outcome1. Steady state oxygen consumption at 50%Wmax;
2. In vivo mitochondrial function (31P MRS);
3. In vitro mitochondrial function (state 3, 4, U respiration).
- Secondary outcome1. mtDNA copy number;
2. C1, C2, C3, C4, F1F0ATPase, ANT content;
3. Muscle fiber type composition.
- TimepointsDay 1 and day 8.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.P.J. Schmitz
- CONTACT for SCIENTIFIC QUERIES J.P.J. Schmitz
- Sponsor/Initiator Eindhoven University of Technology, Erasmus Medical Center, Máxima Medical Center, University Hospital Maastricht (AZM), University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Eindhoven University of Technology, Erasmus Medical Center, Maxima Medical Center, University Hospital Maastricht (AZM), University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThe objective of the study is to test if supplementation of dietary inorganic nitrate (8.5 mg/kg body wt/day) to normal diet improves exercise performance in patients with mitochondrial myopathy. The main study parameters to asses the effect of nitrate intake will be: (i) steady state oxygen consumption at 50%Wmax, (ii) in vivo mitochondrial function (31P MRS), (iii) in vitro mitochondrial function (state 3, 4, U respiration).
- Main changes (audit trail)
- RECORD23-feb-2012 - 10-mrt-2012


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