High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID

NCT00983983

Run by

Massachusetts General Hospital

People needed

28

Starts

2009-10-01

Expected to finish

2013-05-01

Last updated by the study team

2015-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Barrow Neurological Institute/St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of California at Irvine — Irvine, California, United States
• California Pacific Medical Center, University of California at San Francisco — San Francisco, California, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Neurology Clinical Trials Unit, Massachusetts General Hospital — Boston, Massachusetts, United States
• Saint Mary's Health Care — Grand Rapids, Michigan, United States
• Columbia Presbyterian Medical Center — New York, New York, United States
• Carolinas Medical Center Neuromuscular/ALS-MDA Center — Charlotte, North Carolina, United States
• Oregan Health and Science University — Portland, Oregon, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Methodist Neurological Institute — Houston, Texas, United States
• University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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