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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
KetoCal
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Ketogenic Diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins ALS Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KetoCal

Arm Description

KetoCal tube feeding formula

Outcomes

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

Secondary Outcome Measures

Evaluate changes in motor function, strength, fatigue, body fat and cognitive function

Full Information

First Posted
November 18, 2009
Last Updated
March 30, 2015
Sponsor
Johns Hopkins University
Collaborators
Nutricia North America, Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01016522
Brief Title
Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Safety and Tolerability of the Ketogenic Diet in ALS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Nutricia North America, Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, Ketogenic Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KetoCal
Arm Type
Experimental
Arm Description
KetoCal tube feeding formula
Intervention Type
Dietary Supplement
Intervention Name(s)
KetoCal
Intervention Description
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Gastrostomy tube in place for the prior month Appel ALS score less than 100 Able to stand on a scale with assistance 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 Willing to chart food intake during the six-month study Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days Not taking Coenzyme Q10 or on a stable dose and brand for 30 days Absence of exclusion criteria Exclusion Criteria: Forced vital capacity <50% of predicted Dependence on mechanical ventilation for more than 12 hours per day Exposure to any experimental agent within 30 days of onset of this protocol Women who are pregnant or planning to become pregnant Women of childbearing potential not practicing 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 3 X ULN Patients who have a pacemaker or other internal electronic medical device
Facility Information:
Facility Name
Johns Hopkins ALS Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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

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