High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

This study has been completed.

Sponsor:

Collaborator:

Muscular Dystrophy Association

Information provided by (Responsible Party):

Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00983983

First received: September 23, 2009

Last updated: February 11, 2015

Last verified: February 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

September 23, 2009

Last Updated Date

February 11, 2015

Start Date ^ICMJE

October 2009

Primary Completion Date

April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Adverse events and subject compliance rates. [ Time Frame: 5 months follow-up ]

Change History

Complete list of historical versions of study NCT00983983 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.
Biomarkers of Body Composition and Lipid Metabolism [ Time Frame: 5 months follow-up ]

Original Secondary Outcome Measures ^ICMJE

Biomarkers of Body Composition and Lipid Metabolism [ Time Frame: 5 months follow-up ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

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.
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.
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.

Study Arms

Experimental: High fat/high calorie
High fat/high calorie diet: Oxepa

Intervention: Dietary Supplement: Oxepa
Active Comparator: High calorie
High calorie diet: Jevity 1.5

Intervention: Dietary Supplement: Jevity 1.5
Placebo Comparator: Control
Control diet: Jevity 1.0

Intervention: Dietary Supplement: Jevity 1.0

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2013

Primary Completion Date

April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00983983

Other Study ID Numbers ^ICMJE

MDA136152
2009-P-001132

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Muscular Dystrophy Association

Investigators ^ICMJE

Principal Investigator:

Anne-Marie A Wills, M.D.

Massachusetts General Hospital

PRS Account

Massachusetts General Hospital

Verification Date

February 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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