Modified Ketogenic Diet in Patients With McArdle Disease Part A (NCT03843606) | Clinical Trial Compass
CompletedNot Applicable
Modified Ketogenic Diet in Patients With McArdle Disease Part A
Denmark11 participantsStarted 2019-02-16
Plain-language summary
McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle.
We hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle.
In this open interventional pilot study we wish to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet that ensures adequate degree of ketosis and at the same time is well tolerated for patients with McArdle disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Genetically confirmed GSDV
* Patient is willing and able to provide written informed consent prior to participation.
* Patient is ambulatory.
* Women in fertile age must be willing to practice the following medically acceptable methods of birth control
Exclusion Criteria:
* Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
* Pregnancy or breastfeeding
* Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments
* Patients with porphyria or disorders of fat metabolism (primary carnitine deficiency, carnitine palmitoyltransferase I or II, β-oxidation defects etc.).