Status:
COMPLETED
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Muscular Dystrophy Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 scleros...
Detailed Description
Weight loss is a common and severe symptom of amyotrophic lateral sclerosis (ALS), caused both from inadequate calorie intake and an increased metabolic rate. People with ALS are generally instructed ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of ALS
- Male or female subjects aged 18 years or older
- Must already be tolerating tube feedings through either a gastrostomy tube (G-tube or PEG) or jejunostomy tube (J-tube)
- Must require non-invasive ventilation (BIPAP) for less than 10 hours/day
- Women of childbearing potential must have a negative pregnancy test at screening and be non-lactating.
Exclusion
- History of hepatitis including non-alcoholic steatohepatitis (NASH), cholecystectomy, prior biliary disease such as gallstones
- History of diabetes
- History of prior myocardial infarction or stroke
- 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
- Allergy to soy, fish, or milk products
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00983983
Start Date
October 1 2009
End Date
May 1 2013
Last Update
February 27 2015
Active Locations (13)
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1
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
University of California at Irvine
Irvine, California, United States, 92868
3
California Pacific Medical Center, University of California at San Francisco
San Francisco, California, United States, 94120
4
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239