Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)
NCT01016522 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2015-04-01
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
Interventions
- DIETARY_SUPPLEMENT
-
KetoCal
Ketogenic Diet food via gastrostomy tube - 80% fat, 17% protein, 3% carbohydrates
Sponsors & Collaborators
-
Nutricia North America
collaborator INDUSTRY - collaborator OTHER
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2011-02-28
- Completion
- 2012-01-31
Countries
- United States
Study Locations
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