Phase II Safety and Tolerability Study of High Fat/High Calorie Versus High Calorie Versus Optimal Nutrition in Subjects With Amyotrophic Lateral Sclerosis

Study 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).

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:

Dietary Supplement

Intervention Name:

Oxepa, Jevity 1.5, Jevity 1.0



Phase 2

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

Anne-Marie A Wills, M.D., Massachusetts General Hospital ID:


Neals Affiliated?


Coordinating Center Contact Information

Massachusetts General Hospital

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:

Massachusetts General Hospital

Participant Duration:

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

Estimated Enrollment:


Estimated Study Start Date:

09 / 30 / 2009

Estimated Study Completion Date:

05 / 01 / 2013

Posting Last Modified Date:

02 / 27 / 2015

Date Study Added to

09 / 24 / 2009

Minimum Age:

18 Years

Maximum Age:


Can participants use Riluzole?


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

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center

Phoenix, Arizona 85013
United States

University of California at Irvine

Irvine, California 92868
United States

California Pacific Medical Center, University of California at San Francisco

San Francisco, California 94120
United States

Sarasota Memorial Hospital

Sarasota, Florida 34239
United States

Emory University School of Medicine

Atlanta, Georgia 30322
United States

Neurology Clinical Trials Unit, Massachusetts General Hospital

Boston, Massachusetts 02114
United States

Saint Mary's Health Care

Grand Rapids, Michigan 49503
United States

Columbia Presbyterian Medical Center

New York, New York 10032
United States

Carolinas Medical Center Neuromuscular/ALS-MDA Center

Charlotte, North Carolina 28207
United States

Oregan Health and Science University

Portland, Oregon 97239
United States

Drexel University

Philadelphia, Pennsylvania 19107
United States

Methodist Neurological Institute

Houston, Texas 77030
United States

University of Vermont

Burlington, Vermont 05401
United States