Phase 2
N=24
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00983983 ↗Enrolled (actual)
24
Serious AEs
35.0%
Results posted
Feb 2015
Primary outcome: Primary: Safety Outcomes: Frequency of Adverse Events — 49; 24; 42 Total Number of Adverse Events — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxepa (Dietary_supplement); Jevity 1.5 (Dietary_supplement); Jevity 1.0 (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Outcomes: Frequency of Adverse Events |
49; 24; 42 | 0.06 |
| PRIMARY Serious Adverse Events |
3; 0; 9 | 0.0005 sig |
| PRIMARY Tolerability |
5; 7; 1 | 0.03 sig |
| SECONDARY Rate of Change in ALSFRS-R in Units/Month |
-1.54; -1.07; -2.17 | 0.07 |
| SECONDARY Biomarkers of Body Composition and Lipid Metabolism |
— | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00983983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.