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

NCT01016522 | Terminated Phase 3 DMC

• 1 other identifier: NA_00008855
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS; Ketogenic Diet

Outcome Measures

Primary Outcomes (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

  28 weeks

Secondary Outcomes (1)

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

  28 weeks

Study Arms (1)

KetoCal

EXPERIMENTAL

KetoCal tube feeding formula

Dietary Supplement: KetoCal

Interventions

KetoCal DIETARY_SUPPLEMENT

Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates

KetoCal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Nutricia North America: collaborator
• Cornell University: collaborator

Study Sites (1)

Johns Hopkins ALS Clinic

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2012
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (1)