Amyotrophic Lateral SclerosisPhase 2NCT00983983

High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

A Phase 2 study testing Oxepa, Jevity 1.5 and Jevity 1.0 in people with Amyotrophic Lateral Sclerosis, run by Massachusetts General Hospital at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis
What is being tested?: Oxepa, Jevity 1.5 and Jevity 1.0
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 13 sitesUnited States
Study dates: Oct 2009to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Amyotrophic Lateral Sclerosis
Being tested: Oxepa, Jevity 1.5, Jevity 1.0
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)
Medical subject headings: Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Platelet Glycoprotein IV Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
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.

Study groups in NCT00983983
Study group	Role	What they receive
High fat/high calorie	Experimental	High fat/high calorie diet: Oxepa Receives: Dietary Supplement: Oxepa
High calorie	Active comparator	High calorie diet: Jevity 1.5 Receives: Dietary Supplement: Jevity 1.5
Control	Placebo comparator	Control diet: Jevity 1.0 Receives: Dietary Supplement: Jevity 1.0

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: Over 5 months
Biomarkers of Body Composition and Lipid Metabolism
Measured: 5 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009May 2013

First posted24 Sep 2009 (estimated)
Study startOct 2009
Primary completionApr 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00983983
Sponsor's protocol ID: MDA136152
Other IDs: 2009-P-001132
Status last verified: Feb 2015
First submitted: 23 Sep 2009
Last updated: 27 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1093/ajcn/63.1.130.
PubMed 8604660
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.
PubMed 16909026
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.
PubMed 11522556
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.
PubMed 18300717
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.
PubMed 16648143
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.
PubMed 17114821
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.
PubMed 15263088
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.
PubMed 24582471
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.
PubMed 21607987

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00983983
Acronym / sponsor ID: MDA136152
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis, ALS, Motor Neuron Disease, MND, Fat, Lipid, Cholesterol, Omega-3 fatty acid
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Muscular Dystrophy Association
Study start: Oct 2009
Primary completion: Apr 2013 (actual)
Study completion: May 2013 (actual)
First posted: 24 Sep 2009 (estimated)
Results: Posted 27 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High fat/high calorie	Experimental	Dietary Supplement: OxepaHigh fat/high calorie diet: Oxepa
High calorie	Active comparator	Dietary Supplement: Jevity 1.5High calorie diet: Jevity 1.5
Control	Placebo comparator	Dietary Supplement: Jevity 1.0Control diet: Jevity 1.0

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxepaOxepa: 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.	Dietary supplement	High fat/high calorie
Jevity 1.5Jevity 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.	Dietary supplement	High calorie
Jevity 1.0Jevity 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.	Dietary supplement	Control

Primary outcome

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

2 secondary outcomes

Rate of Change in ALSFRS-R in Units/Month
Time frame: Over 5 months
Biomarkers of Body Composition and Lipid Metabolism
Time frame: 5 months follow-up

Results and safety

Results posted to the registry on 27 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Fat/High Calorie	8	6
High Calorie	9	8
Control	7	6

Primary outcome: Safety Outcomes: Frequency of Adverse Events

Time frame: 5 months. Number. Unit: Total Number of Adverse Events

Measure	High Fat/High Calorie n = 8	High Calorie n = 9	Control n = 7
Value	49	24	42

High Calorie vs Control: p = 0.06, Fisher Exact

Primary outcome: Serious Adverse Events

Time frame: 5 months. Number. Unit: Number of Serious Adverse Events

Measure	High Fat/High Calorie n = 8	High Calorie n = 9	Control n = 7
Value	3	0	9

High Calorie vs Control: p = 0.0005, Fisher Exact

Primary outcome: Tolerability

Time frame: 5 months. Number. Unit: participants

Measure	High Fat/High Calorie n = 6	High Calorie n = 8	Control n = 6
Value	5	7	1

High Calorie vs Control: p = 0.03, Fisher Exact

Population analysed: The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were followed for adverse events for 30 days after stopping study diet.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Fat/High Calorie	3 of 6 (50%)	6 of 6 (100%)	Not reported
High Calorie/High Carbohydrate	0 of 8 (0%)	8 of 8 (100%)	Not reported
Control	4 of 6 (66.7%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8604660Kasarskis 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.
Background: PubMed 16909026Desport 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.
Background: PubMed 11522556Desport 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.
Background: PubMed 18300717Morozova 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.
Background: PubMed 16648143Veldink 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.
Background: PubMed 17114821Mattson 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.
Background: PubMed 15263088Dupuis 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 publication: PubMed 24582471Wills 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.
Derived from this study: PubMed 21607987Paganoni 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne-Marie A Wills, M.D. principal investigator

Massachusetts General Hospital

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxepa, Jevity 1.5 and Jevity 1.0 in people with Amyotrophic Lateral Sclerosis, run by Massachusetts General Hospital at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcomes: Frequency of Adverse Events (time frame: 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00983983, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015.