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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Safety and Tolerability of the Ketogenic Diet in ALS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01016522
• Other study ID #: NA_00008855
• Status: Terminated
• Phase: Phase 3
• First received: November 18, 2009
• Last updated: March 30, 2015
• Start date: November 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01035710

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Dietary Supplement:
• KetoCal
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates

Locations

Country	Name	City	State
United States	Johns Hopkins ALS Clinic	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Cornell University, Nutricia North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate changes in motor function, strength, fatigue, body fat and cognitive function		28 weeks	Yes