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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: March 30, 2015
Last verified: March 2015
History of Changes
  Purpose

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 Intervention Phase
Amyotrophic Lateral Sclerosis
 Dietary Supplement: KetoCal
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Tolerability of the Ketogenic Diet in ALS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Evaluate changes in motor function, strength, fatigue, body fat and cognitive function [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]
Enrollment: 1
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KetoCal
KetoCal tube feeding formula
 Dietary Supplement: KetoCal
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
Other Name: KetoCal

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016522

Locations
United States, Maryland
Johns Hopkins ALS Clinic
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Nutricia North America
Cornell University
  More Information

No publications provided

Responsible Party: Vinay Chaudhry, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01016522     History of Changes
Obsolete Identifiers: NCT01035710
Other Study ID Numbers: NA_00008855
Study First Received: November 18, 2009
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
ALS
Ketogenic Diet

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
 Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on September 25, 2015