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Clinical Trials/NCT01016522
NCT01016522TerminatedPhase 3

Safety and Tolerability of the Ketogenic Diet in ALS

Johns Hopkins University1 site in 1 country1 target enrollmentStarted: November 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
1
Locations
1
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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
  • •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

Arms & Interventions

KetoCal

Experimental

KetoCal tube feeding formula

Intervention: KetoCal (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • Evaluate changes in motor function, strength, fatigue, body fat and cognitive function(28 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Vinay Chaudhry

Professor

Johns Hopkins University

Study Sites (1)

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