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High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxepa
Jevity 1.5
Jevity 1.0
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
  • University of California at Irvine
  • California Pacific Medical Center, University of California at San Francisco
  • Sarasota Memorial Hospital
  • Emory University School of Medicine
  • Neurology Clinical Trials Unit, Massachusetts General Hospital
  • Saint Mary's Health Care
  • Columbia Presbyterian Medical Center
  • Carolinas Medical Center Neuromuscular/ALS-MDA Center
  • Oregan Health and Science University
  • Drexel University
  • Methodist Neurological Institute
  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

High fat/high calorie

High calorie

Control

Arm Description

High fat/high calorie diet: Oxepa

High calorie diet: Jevity 1.5

Control diet: Jevity 1.0

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Change in ALSFRS-R in Units/Month
Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.
Biomarkers of Body Composition and Lipid Metabolism

Full Information

First Posted
September 23, 2009
Last Updated
February 11, 2015
Sponsor
Massachusetts General Hospital
Collaborators
Muscular Dystrophy Association
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1. Study Identification

Unique Protocol Identification Number
NCT00983983
Brief Title
High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Muscular Dystrophy Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fat/high calorie
Arm Type
Experimental
Arm Description
High fat/high calorie diet: Oxepa
Arm Title
High calorie
Arm Type
Active Comparator
Arm Description
High calorie diet: Jevity 1.5
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control diet: Jevity 1.0
Intervention Type
Dietary Supplement
Intervention Name(s)
Oxepa
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Jevity 1.5
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Jevity 1.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Outcomes: Frequency of Adverse Events
Time Frame
5 months
Title
Serious Adverse Events
Description
SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame
5 months
Title
Tolerability
Description
Number of participants who completed the study on their assigned study intervention.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Rate of Change in ALSFRS-R in Units/Month
Description
Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.
Time Frame
Over 5 months
Title
Biomarkers of Body Composition and Lipid Metabolism
Time Frame
5 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie A Wills, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California at Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Pacific Medical Center, University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94120
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Neurology Clinical Trials Unit, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolinas Medical Center Neuromuscular/ALS-MDA Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Oregan Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8604660
Citation
Kasarskis EJ, Berryman S, Vanderleest JG, Schneider AR, McClain CJ. Nutritional status of patients with amyotrophic lateral sclerosis: relation to the proximity of death. Am J Clin Nutr. 1996 Jan;63(1):130-7. doi: 10.1093/ajcn/63.1.130.
Results Reference
background
PubMed Identifier
16909026
Citation
Desport JC, Torny F, Lacoste M, Preux PM, Couratier P. Hypermetabolism in ALS: correlations with clinical and paraclinical parameters. Neurodegener Dis. 2005;2(3-4):202-7. doi: 10.1159/000089626.
Results Reference
background
PubMed Identifier
11522556
Citation
Desport JC, Preux PM, Magy L, Boirie Y, Vallat JM, Beaufrere B, Couratier P. Factors correlated with hypermetabolism in patients with amyotrophic lateral sclerosis. Am J Clin Nutr. 2001 Sep;74(3):328-34. doi: 10.1093/ajcn/74.3.328.
Results Reference
background
PubMed Identifier
18300717
Citation
Morozova N, Weisskopf MG, McCullough ML, Munger KL, Calle EE, Thun MJ, Ascherio A. Diet and amyotrophic lateral sclerosis. Epidemiology. 2008 Mar;19(2):324-37. doi: 10.1097/EDE.0b013e3181632c5d.
Results Reference
background
PubMed Identifier
16648143
Citation
Veldink JH, Kalmijn S, Groeneveld GJ, Wunderink W, Koster A, de Vries JH, van der Luyt J, Wokke JH, Van den Berg LH. Intake of polyunsaturated fatty acids and vitamin E reduces the risk of developing amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):367-71. doi: 10.1136/jnnp.2005.083378. Epub 2006 Apr 28. Erratum In: J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):779.
Results Reference
background
PubMed Identifier
17114821
Citation
Mattson MP, Cutler RG, Camandola S. Energy intake and amyotrophic lateral sclerosis. Neuromolecular Med. 2007;9(1):17-20. doi: 10.1385/nmm:9:1:17.
Results Reference
background
PubMed Identifier
15263088
Citation
Dupuis L, Oudart H, Rene F, Gonzalez de Aguilar JL, Loeffler JP. Evidence for defective energy homeostasis in amyotrophic lateral sclerosis: benefit of a high-energy diet in a transgenic mouse model. Proc Natl Acad Sci U S A. 2004 Jul 27;101(30):11159-64. doi: 10.1073/pnas.0402026101. Epub 2004 Jul 19.
Results Reference
background
PubMed Identifier
24582471
Citation
Wills AM, Hubbard J, Macklin EA, Glass J, Tandan R, Simpson EP, Brooks B, Gelinas D, Mitsumoto H, Mozaffar T, Hanes GP, Ladha SS, Heiman-Patterson T, Katz J, Lou JS, Mahoney K, Grasso D, Lawson R, Yu H, Cudkowicz M; MDA Clinical Research Network. Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Jun 14;383(9934):2065-2072. doi: 10.1016/S0140-6736(14)60222-1. Epub 2014 Feb 28.
Results Reference
result
PubMed Identifier
21607987
Citation
Paganoni S, Deng J, Jaffa M, Cudkowicz ME, Wills AM. Body mass index, not dyslipidemia, is an independent predictor of survival in amyotrophic lateral sclerosis. Muscle Nerve. 2011 Jul;44(1):20-4. doi: 10.1002/mus.22114. Epub 2011 May 23.
Results Reference
derived

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High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

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