Study Purpose:
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of long-term use of high fat/high calorie and high calorie diets in people with amyotrophic lateral sclerosis (ALS) (Lou Gehrig's disease).Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Dietary Supplement
Intervention Name:
Oxepa, Jevity 1.5, Jevity 1.0
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Anne-Marie A Wills, M.D., Massachusetts General Hospital
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Massachusetts General Hospital
149 13th Street
Charlestown, Massachusetts, 02129 United States
Full Study Summary:
Study Sponsor:
Massachusetts General Hospital
Participant Duration:
5 ½ months; 5 visits in clinic; 4 telephone visits. Visits last approximately 2.5 to 5 hours.
Estimated Enrollment:
28
Estimated Study Start Date:
09 / 30 / 2009
Estimated Study Completion Date:
05 / 01 / 2013
Posting Last Modified Date:
02 / 27 / 2015
Date Study Added to neals.org:
09 / 24 / 2009
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:1. Clinical diagnosis of ALS
2. Male or female subjects aged 18 years or older
3. Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or PEG) or jejunostomy tube (J-tube)
4. Must require non-invasive ventilation (BIPAP) for less than 10 hours/day
5. Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
Exclusion Criteria:
1. History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy, prior biliary disease such as gallstones
2. History of diabetes
3. History of prior myocardial infarction or stroke
4. Laboratory values: Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 times the upper limit of normal or total bilirubin greater than 1.5 times the upper limit of normal
5. Allergy to soy, fish, or milk products
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