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

Safety and Tolerability of the Ketogenic Diet in ALS

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01016522

Enrollment

Registered

2009-11-19

Start date

2009-11-30

Completion date

2012-01-31

Last updated

2015-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

ALS, Ketogenic Diet

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.

Interventions

DIETARY_SUPPLEMENTKetoCal

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Evaluate changes in motor function, strength, fatigue, body fat and cognitive function	28 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026