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

 
Study Focus:
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), Sporadic ALS, Familial ALS
Study Category:
Nutrition
Study Status:
Closed
Study Results:
https://clinicalt...CT00983983&rank=1
Phase:
Phase II
Type:
Interventional Trial
with active agents/drugs & a placebo
Funding Source:
Muscular Dystrophy Association (MDA)
Study Chair(s)/Principal Investigator(s):
Anne-Marie Wills MD, (Massachusetts General Hospital)
Clinicaltrials.gov ID:
NCT00983983
NEALS Affiliated?
Yes
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.
Participant Duration:
5 ½ months; 5 visits in clinic; 4 telephone visits. Visits last approximately 2.5 to 5 hours.
# of Subjects:
30
Enrollment Start Date:
10/01/2009
Enrollment End Date:
12/01/-0001
Posting Last Modified Date:
11/01/2012
Date Study Added to alsconsortium.org:
10/13/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
N/A
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Not applicable
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Katy Mahoney
kmahoney17@partners.org
617-643-7434
Massachusetts General Hospital
149 13th Street
Charlestown, Massachusetts 02129
UNITED STATES
Other 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

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