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High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT00983983
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 23, 2009
First Posted Date  ICMJE September 24, 2009
Results First Submitted Date  ICMJE September 16, 2014
Results First Posted Date  ICMJE February 27, 2015
Last Update Posted Date February 27, 2015
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2015)
  • Safety Outcomes: Frequency of Adverse Events [ Time Frame: 5 months ]
  • Serious Adverse Events [ Time Frame: 5 months ]
    SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
  • Tolerability [ Time Frame: 5 months ]
    Number of participants who completed the study on their assigned study intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ]
Change History Complete list of historical versions of study NCT00983983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2015)
  • Rate of Change in ALSFRS-R in Units/Month [ Time Frame: Over 5 months ]
    Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.
  • Biomarkers of Body Composition and Lipid Metabolism [ Time Frame: 5 months follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2009)
Biomarkers of Body Composition and Lipid Metabolism [ Time Frame: 5 months follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
Official Title  ICMJE Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis
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 sclerosis (ALS) (Lou Gehrig's disease).
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2013)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2009)
60
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00983983
Other Study ID Numbers  ICMJE MDA136152
2009-P-001132
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Muscular Dystrophy Association
Investigators  ICMJE
Principal Investigator: Anne-Marie A Wills, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2015

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