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This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
Age 18 or older
Capable of providing informed consent and complying with trial procedures
Gastrostomy tube in place for the prior month
Appel ALS score less than 100
Able to stand on a scale with assistance
For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:
Willing to chart food intake during the six-month study
Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
Absence of exclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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