High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

February 11, 2015 updated by: Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcomes: Frequency of Adverse Events
Time Frame: 5 months
5 months
Serious Adverse Events
Time Frame: 5 months
SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
5 months
Tolerability
Time Frame: 5 months
Number of participants who completed the study on their assigned study intervention.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Over 5 months
Biomarkers of Body Composition and Lipid Metabolism
Time Frame: 5 months follow-up
5 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Muscular Dystrophy Association

Investigators

  • Principal Investigator: Anne-Marie A Wills, M.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (Estimate)

September 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDA136152
  • 2009-P-001132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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