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Trial record 1 of 1 for:    NCT01016522
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Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01016522
Recruitment Status : Terminated
First Posted : November 19, 2009
Last Update Posted : April 1, 2015
Nutricia North America
Cornell University
Information provided by (Responsible Party):
Vinay Chaudhry, Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: KetoCal Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of the Ketogenic Diet in ALS
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: KetoCal
KetoCal tube feeding formula
Dietary Supplement: KetoCal
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluate changes in motor function, strength, fatigue, body fat and cognitive function [ Time Frame: 28 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01016522

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United States, Maryland
Johns Hopkins ALS Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Nutricia North America
Cornell University
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Responsible Party: Vinay Chaudhry, Professor, Johns Hopkins University Identifier: NCT01016522    
Obsolete Identifiers: NCT01035710
Other Study ID Numbers: NA_00008855
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Vinay Chaudhry, Johns Hopkins University:
Ketogenic Diet
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases