Safety of Caprylic Triglycerides in ALS: A Pilot Study

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,
• Appel ALS score less than 100,
• Able to stand on a scale with assistance,
• Willing to chart food intake during the 12 week study,
• Patients either not taking Riluzole (Rilutek) or on a stable dose for 30 days or more,
• Not taking Coenzyme Q10 or on a stable dose and brand for 30 days,
• Absence of exclusion criteria.

Exclusion criteria

• Forced vital capacity <40% of predicted,
• Dependence on mechanical ventilation for more than 12 hours per day,
• Exposure to any experimental agent within 30 days of entry or at any time during the trial,
• Women who are breastfeeding, who are pregnant or are planning to become pregnant,
• Women of childbearing potential not practicing a medically accepted form of contraception,
• Enrollment in another research study within 30 days of or during this trial,
• Mini-Mental State Exam (MMSE) score <20,
• Patients with symptomatic cardiac disease or hypercholesterolemia,
• Patients with myocardial infarction within 6 months of this trial,
• Renal dysfunction defined as BUN and creatinine >2xULN,
• Known mitochondrial disease,
• BMI<18.5,
• Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial,
• Impaired liver function, defined as AST or ALT of 3xULN,
• Patients who have a pacemaker or other internal electronic medical device,
• Known allergy or hypersensitivity to milk or soy products.