Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

This study has been terminated.
Sponsor:
Collaborators:
Nutricia North America
Cornell University
Information provided by (Responsible Party):
Vinay Chaudhry, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01016522
First received: November 18, 2009
Last updated: November 17, 2011
Last verified: November 2011

November 18, 2009
November 17, 2011
November 2009
December 2012   (final data collection date for primary outcome measure)
Study will determine if humans with ALS fed a strictly controlled diet designed to generate large amounts of ketones is safe and well-tolerated without evidence of weight loss or other adverse effect [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01016522 on ClinicalTrials.gov Archive Site
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)
Safety and Tolerability of the Ketogenic Diet in ALS

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Dietary Supplement: KetoCal
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
Other Name: KetoCal
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
  2. Age 18 or older
  3. Capable of providing informed consent and complying with trial procedures
  4. Gastrostomy tube in place for the prior month
  5. Appel ALS score less than 100
  6. Able to stand on a scale with assistance
  7. For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:

    • Prepare, administer and log tube feeds
    • Check and log gastric residuals
    • Assist with weighing subject at home if necessary
  8. Willing to chart food intake during the six-month study
  9. Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
  10. Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
  11. Absence of exclusion criteria

Exclusion Criteria:

  1. Forced vital capacity <50% of predicted
  2. Dependence on mechanical ventilation for more than 12 hours per day
  3. Exposure to any experimental agent within 30 days of onset of this protocol
  4. Women who are pregnant or planning to become pregnant
  5. Women of childbearing potential not practicing contraception
  6. Enrollment in another research study within 30 days of or during this trial
  7. Mini-Mental State Exam (MMSE) score <20
  8. Patients with symptomatic cardiac disease or hypercholesterolemia
  9. Patients with myocardial infarction within 6 months of this trial
  10. Renal dysfunction defined as BUN and creatinine >2XULN
  11. Known mitochondrial disease
  12. BMI<18.5
  13. Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial
  14. Impaired liver function, defined as AST or ALT of 3 X ULN
  15. Patients who have a pacemaker or other internal electronic medical device
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01016522
NA_00008855
Yes
Vinay Chaudhry, Johns Hopkins University
Johns Hopkins University
  • Nutricia North America
  • Cornell University
Not Provided
Johns Hopkins University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP