Clinical trial: Safety of Caprylic Triglycerides in ALS: A Pilot Study (NCT02716662)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 99 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment