High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00983983
First received: September 23, 2009
Last updated: July 1, 2013
Last verified: July 2013

September 23, 2009
July 1, 2013
October 2009
April 2013   (final data collection date for primary outcome measure)
Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00983983 on ClinicalTrials.gov Archive Site
Biomarkers of body composition and lipid metabolism [ Time Frame: 5 months follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis

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).

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 to increase their calorie intake; however, the ideal amount and type of calories has not been studied. Several studies in an animal model of motor neuron disease have shown that a high fat/high calorie diet can increase survival by as much as 38%. Mice on a high fat diet also live longer than mice fed diets consisting of high protein or high sugar. We are therefore conducting a phase II safety, tolerability, and preliminary efficacy trial in ALS of high fat versus high calorie versus normal diet. The normal diet will be calculated based on the number of calories needed to replace each participant's measured daily calorie requirement.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Dietary Supplement: Oxepa
    Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
  • Dietary Supplement: Jevity 1.5
    Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
  • Dietary Supplement: Jevity 1.0
    Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability.
  • Experimental: High fat/high calorie
    High fat/high calorie diet: Oxepa
    Intervention: Dietary Supplement: Oxepa
  • Active Comparator: High calorie
    High calorie diet: Jevity 1.5
    Intervention: Dietary Supplement: Jevity 1.5
  • Placebo Comparator: Control
    Control diet: Jevity 1.0
    Intervention: Dietary Supplement: Jevity 1.0

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
May 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00983983
MDA136152, 2009-P-001132
Yes
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
Massachusetts General Hospital
Muscular Dystrophy Association
Principal Investigator: Anne-Marie A Wills, M.D. Massachusetts General Hospital
Massachusetts General Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP