High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

Phase 2

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Dietary Supplement: Oxepa; Dietary Supplement: Jevity 1.0; Dietary Supplement: Jevity 1.5

• Registration Number: NCT00983983
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Start: 2009-10
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Results First Submitted: 2014-09-16
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-11
• Last Update Submitted: 2015-02-11
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High fat/high calorie	Oxepa	High fat/high calorie diet: Oxepa
Control	Jevity 1.0	Control diet: Jevity 1.0
High calorie	Jevity 1.5	High calorie diet: Jevity 1.5

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of Change in ALSFRS-R in Units/Month	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	5 months follow-up

Trial Locations

Locations (13)

University of California at Irvine; 🇺🇸 Irvine, California, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Neurology Clinical Trials Unit, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Drexel University; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Methodist Neurological Institute; 🇺🇸 Houston, Texas, United States

Saint Mary's Health Care; 🇺🇸 Grand Rapids, Michigan, United States

Carolinas Medical Center Neuromuscular/ALS-MDA Center; 🇺🇸 Charlotte, North Carolina, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Barrow Neurological Institute/St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

California Pacific Medical Center, University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Oregan Health and Science University; 🇺🇸 Portland, Oregon, United States