NCT00983983

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

3.5 years

First QC Date

September 23, 2009

Results QC Date

September 16, 2014

Last Update Submit

February 11, 2015

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisALSMotor Neuron DiseaseMNDFatLipidCholesterolOmega-3 fatty acidDietTube feedGastrostomyPEGAdults with Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (3)

  • Safety Outcomes: Frequency of Adverse Events

    5 months

  • Serious Adverse Events

    SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

    5 months

  • Tolerability

    Number of participants who completed the study on their assigned study intervention.

    5 months

Secondary Outcomes (2)

  • Rate of Change in ALSFRS-R in Units/Month

    Over 5 months

  • Biomarkers of Body Composition and Lipid Metabolism

    5 months follow-up

Study Arms (3)

High fat/high calorie

EXPERIMENTAL

High fat/high calorie diet: Oxepa

Dietary Supplement: Oxepa

High calorie

ACTIVE COMPARATOR

High calorie diet: Jevity 1.5

Dietary Supplement: Jevity 1.5

Control

PLACEBO COMPARATOR

Control diet: Jevity 1.0

Dietary Supplement: Jevity 1.0

Interventions

OxepaDIETARY_SUPPLEMENT

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.

High fat/high calorie
Jevity 1.5DIETARY_SUPPLEMENT

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.

High calorie
Jevity 1.0DIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

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

Phoenix, Arizona, 85013, United States

Location

University of California at Irvine

Irvine, California, 92868, United States

Location

California Pacific Medical Center, University of California at San Francisco

San Francisco, California, 94120, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Neurology Clinical Trials Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

Carolinas Medical Center Neuromuscular/ALS-MDA Center

Charlotte, North Carolina, 28207, United States

Location

Oregan Health and Science University

Portland, Oregon, 97239, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19107, United States

Location

Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (9)

  • 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.

    PMID: 8604660BACKGROUND

  • 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.

    PMID: 16909026BACKGROUND

  • 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.

    PMID: 11522556BACKGROUND

  • 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.

    PMID: 18300717BACKGROUND

  • 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.

    PMID: 16648143BACKGROUND

  • 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.

    PMID: 17114821BACKGROUND

  • 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.

    PMID: 15263088BACKGROUND

  • 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.

    PMID: 24582471RESULT

  • 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.

    PMID: 21607987DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisMotor Neuron DiseasePlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Anne-Marie Wills
Organization
Massachusetts General Hospital
awills@partners.org
855-644-6387

Study Officials

  • Anne-Marie A Wills, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2013

Study Completion

May 1, 2013

Last Updated

February 27, 2015

Results First Posted

February 27, 2015

Record last verified: 2015-02

Locations

US(13)