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
  Purpose

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).


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Dietary Supplement: Oxepa
Dietary Supplement: Jevity 1.5
Dietary Supplement: Jevity 1.0
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biomarkers of body composition and lipid metabolism [ Time Frame: 5 months follow-up ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2009
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fat/high calorie
High fat/high calorie diet: Oxepa
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.
Active Comparator: High calorie
High calorie diet: Jevity 1.5
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.
Placebo Comparator: Control
Control diet: Jevity 1.0
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983983

Locations
United States, Arizona
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
University of California at Irvine
Irvine, California, United States, 92868
California Pacific Medical Center, University of California at San Francisco
San Francisco, California, United States, 94120
United States, Florida
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Neurology Clinical Trials Unit, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center Neuromuscular/ALS-MDA Center
Charlotte, North Carolina, United States, 28207
United States, Oregon
Oregan Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Methodist Neurological Institute
Houston, Texas, United States, 77030
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Massachusetts General Hospital
Muscular Dystrophy Association
Investigators
Principal Investigator: Anne-Marie A Wills, M.D. Massachusetts General Hospital
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00983983     History of Changes
Other Study ID Numbers: MDA136152, 2009-P-001132
Study First Received: September 23, 2009
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Amyotrophic Lateral Sclerosis
ALS
Motor Neuron Disease
MND
Fat
Lipid
Cholesterol
Omega-3 fatty acid
Diet
Tube feed
Gastrostomy
PEG
Adults with Amyotrophic Lateral Sclerosis (ALS)

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on October 16, 2014