High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborator:	Muscular Dystrophy Association
Information provided by (Responsible Party):	Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00983983

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).

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Dietary Supplement: Oxepa Dietary Supplement: Jevity 1.5 Dietary Supplement: Jevity 1.0	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Biomarkers of body composition and lipid metabolism [ Time Frame: 5 months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983983

Contacts

Contact: Anne-Marie A Wills, M.D.

(617)643-2643

awills@partners.org

Locations

United States, Arizona
Barrow Neurological Institute/St. Joseph's Hospital and Medical Center	Recruiting
Phoenix, Arizona, United States, 85013
Contact: Gale Kittle, RN, MPH 602-406-4792 Gale.Kittle@CHW.EDU
Principal Investigator: Shafeeq S. Ladha, MD
United States, California
University of California at Irvine	Recruiting
Irvine, California, United States, 92868
Contact: Veronica Martin, BA 714-456-7760 vero@uci.edu
Contact: Sharron Diot, RD (714) 456-2332 sdiot@uci.edu
Principal Investigator: Tahseen Mozaffar, MD
California Pacific Medical Center, University of California at San Francisco	Not yet recruiting
San Francisco, California, United States, 94120
Contact: Dallas A Forshew, RN, BSN 415-600-3604 forshed@cpmcri.org
Contact: Will Harris 415-600-3967 HarrisCW@cpmcri.org
Principal Investigator: Jonathan Katz, MD
Sub-Investigator: Catherine Madison, MD
Sub-Investigator: Robert G Miller, MD
United States, Florida
Sarasota Memorial Hospital	Recruiting
Sarasota, Florida, United States, 34239
Contact: Amanda Miller 941-917-5024 amanda-miller@smh.com
Contact: Mary Bradley, RN, BSN (941) 917-6164 Mary-Bradley@smh.com
Principal Investigator: Gregory Hanes, MD
United States, Georgia
Emory University School of Medicine	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Latoya Shaw 404-727-1673 lqshaw@emory.edu
Principal Investigator: Jonathan Glass, MD
United States, Massachusetts
Neurology Clinical Trials Unit, Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert Lawson, BA 617-726-0563 rjlawson@partners.org
Principal Investigator: Anne-Marie A Wills, MD
Sub-Investigator: Merit E Cudkowicz, MD MSc
United States, Michigan
Saint Mary's Health Care	Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Tiffany VanTilburg 616-685-6315 vantilbt@trinity-health.org
Principal Investigator: Deborah Gelinas, MD
United States, New York
Columbia Presbyterian Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Nicole Armstrong, BA 212-305-8148 na2398@mail.cumc.columbia.edu
Principal Investigator: Hiroshi Mitsumoto, M.D.
Sub-Investigator: Jinsy Andrews, M.D.
United States, North Carolina
Carolinas Medical Center Neuromuscular/ALS-MDA Center	Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Mifflin J O'Neill, MS, RD, LEN 704.446.6252 Mifflin.ONeill@carolinashealthcare.org
Contact: Cynthia Lary, BSMT, RN, CRC 704.446.6063 Cynthia.Lary@carolinashealthcare.org
Principal Investigator: Benjamin Brooks, M.D.
United States, Oregon
Oregan Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Diana Dimitrova, PhD 503-494-7269 dimitrov@ohsu.edu
Principal Investigator: Jau-Shin Lou, M.D. Ph.D
United States, Pennsylvania
Drexel University	Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Christine Barr 267-507-2633 Christine.Barr@DrexelMed.edu
Principal Investigator: Terry Heiman-Patterson, MD
United States, Texas
Methodist Neurological Institute	Recruiting
Houston, Texas, United States, 77030
Contact: Sharon L Halton, LiSW 713-441-3420 slhalton@tmhs.org
Contact: Luis F Lay 713-441-3057 LFLayJr@tmhs.org
Principal Investigator: Ericka P Simpson, M.D.
Sub-Investigator: Milvia Y Pleitez, M.D.
Sub-Investigator: Stanley H Appel, M.D.
United States, Vermont
University of Vermont	Recruiting
Burlington, Vermont, United States, 05401
Contact: Colette Oesterle 802-656-4582 Colette.Oesterle@med.uvm.edu
Contact: Shannon Lucy (802) 656-4582 Shannon.Lucy@uvm.edu
Principal Investigator: Rup Tandan, MD

Sponsors and Collaborators

Massachusetts General Hospital

Muscular Dystrophy Association

Investigators

Principal Investigator:

Anne-Marie A Wills, M.D.

Massachusetts General Hospital

More Information

Additional Information:

Muscular Dystrophy Association (MDA) search engine for ongoing ALS clinical trials This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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. Epub 2006 Apr 28. Erratum in: J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):779.

Mattson MP, Cutler RG, Camandola S. Energy intake and amyotrophic lateral sclerosis. Neuromolecular Med. 2007;9(1):17-20.

Dupuis L, Oudart H, René 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. Epub 2004 Jul 19.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 May 23.

Responsible Party:	Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00983983 History of Changes
Other Study ID Numbers:	MDA136152, 2009-P-001132
Study First Received:	September 23, 2009
Last Updated:	February 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

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)

Additional relevant MeSH terms:

Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012