Trial of High fat/High Calorie Diet versus Optimal Nutrition in Amyotrophic Lateral Sclerosis

Study Purpose:

The purpose of this study is to find out whether a high fat or high calorie diet is safe and can be tolerated by people with amyotrophic lateral sclerosis (ALS).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Nutrition

Study Status:

Not enrolling

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Anne-Marie Wills MD, (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

NCT00983983

Neals Affiliated?

Yes

Coordinating Center Contact Information

Massachusetts General Hospital
Katy Mahoney / .(JavaScript must be enabled to view this email address) / 617-643-7434
.(JavaScript must be enabled to view this email address) 149 13th Street
Charlestown, Massachusetts 02129 United States

Full Study Summary:

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 Sponsor:

Muscular Dystrophy Association (MDA)

Participant Duration:

5 ½ months; 5 visits in clinic; 4 telephone visits. Visits last approximately 2.5 to 5 hours.

Estimated Enrollment:

30

Estimated Study Start Date:

09/30/2009

Estimated Study Completion Date:

11/02/2016

Posting Last Modified Date:

10/31/2012

Date Study Added to alsconsortium.org:

10/12/2011
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    N/A

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
    Gale Kittle / .(JavaScript must be enabled to view this email address) / 602-406-4792
    222 W. Thomas Road, Ste. 404
    Phoenix, Arizona 85013
    United States

    University of California at Irvine
    Veronica Martin / .(JavaScript must be enabled to view this email address) / 714-456-2332
    101 The City Drive South
    Orange, California 92868
    United States

    Sarasota Memorial Hospital
    Amanda Miller / .(JavaScript must be enabled to view this email address) / 941-917-5024
    1540 S, Tamiami Trail, 3rd Floor
    Sarasota, Florida 34239
    United States

    Emory University
    Latoya Shaw / .(JavaScript must be enabled to view this email address) / 404-727-1673
    101 Woodruff Circle, Suite 6000
    Atlanta, Georgia 30322
    United States

    Massachusetts General Hospital
    Robert Lawson / .(JavaScript must be enabled to view this email address) / 617-726-0563
    Bldg. 149, 13th Street CNY, Rm 2274
    Charlestown, Massachusetts 02129
    United States

    Saint Mary's Health Care
    Tiffany VanTilburg / .(JavaScript must be enabled to view this email address) / 616-685-6315
    Grand Rapids, Michigan 49503
    United States

    Columbia University Medical Center/ The Eleanor and Lou Gehrig
    Nicole Armstrong / .(JavaScript must be enabled to view this email address) / 212-305-8148
    710 West 168th Street, NI 9th Floor
    New York, New York 10032
    United States

    Carolinas Medical Center
    Cynthia Lary / .(JavaScript must be enabled to view this email address) / 704-446-6063
    1010 Edgehill Road
    North Charlotte, North Carolina 28207
    United States

    Oregon Health and Science University
    Diana Dimitrova / .(JavaScript must be enabled to view this email address) / 503-494-7269
    OHSU, Dept. Neurology, CR-120, 3181 SW Sam Jackson Park Rd
    Portland, Oregon 97239
    United States

    Drexel University
    Christine Barr / .(JavaScript must be enabled to view this email address) / 215-762-5186
    219 N. Broad Street, The Arnold T. Berman, M.D. Building, 7th Floor
    Philadelphia, Pennsylvania 19107
    United States

    Methodist Hospital Research Institute
    Sharon L. Halton / .(JavaScript must be enabled to view this email address) / 713-441-3420
    6560 Fannin St., Suite 802
    Houston, Texas 77030
    United States

    University of Vermont
    Shannon Lucy / .(JavaScript must be enabled to view this email address) / 802-656-4582
    89 Beaumont Ave. Given C225
    Burlington, Vermont 05405
    United States

  • Study Results