CompletedPhase 2

High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

United States28 participantsStarted 2009-10

Plain-language 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 sclerosis (ALS) (Lou Gehrig's disease).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Safety Outcomes: Frequency of Adverse Events

Timeframe: 5 months

Serious Adverse Events

Timeframe: 5 months

Tolerability

Timeframe: 5 months

Trial details

NCT IDNCT00983983

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2014-09-16

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials