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

NCT ID: NCT01016522

Last Updated: 2015-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KetoCal

KetoCal tube feeding formula

Group Type: EXPERIMENTAL

KetoCal

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

KetoCal

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia North America

INDUSTRY

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Vinay Chaudhry

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Johns Hopkins ALS Clinic

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00008855

Identifier Type: -

Identifier Source: org_study_id

NCT01035710

Identifier Type: -

Identifier Source: nct_alias