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
Results First Received: September 16, 2014  
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
Condition: Amyotrophic Lateral Sclerosis
Interventions: Dietary Supplement: Oxepa
Dietary Supplement: Jevity 1.5
Dietary Supplement: Jevity 1.0

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
4 participants were screened but excluded due to not meeting inclusion criteria (1 due to history of Myocardial Infarction, 1 due to Diabetes, 1 due to low forced vital capacity, and 1 due to the investigator's judgment).

Reporting Groups
  Description
High Fat/High Calorie

High fat/high calorie diet: Oxepa

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.

High Calorie

High calorie diet: Jevity 1.5

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.

Control

Control diet: Jevity 1.0

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.


Participant Flow:   Overall Study
    High Fat/High Calorie     High Calorie     Control  
STARTED     8     9     7  
COMPLETED     6     8     6  
NOT COMPLETED     2     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Fat/High Calorie

High fat/high calorie diet: Oxepa

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.

High Calorie/High Carbohydrate

High calorie diet: Jevity 1.5

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.

Control

Control diet: Jevity 1.0

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.

Total Total of all reporting groups

Baseline Measures
    High Fat/High Calorie     High Calorie/High Carbohydrate     Control     Total  
Number of Participants  
[units: participants]
  8     9     7     24  
Age  
[units: years]
Mean (Standard Deviation)
  64.0  (6.9)     57.5  (15.4)     63.2  (9.4)     61.3  (11.4)  
Gender  
[units: participants]
       
Female     5     5     1     11  
Male     3     4     6     13  
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) [1]
[units: units on a scale]
Mean (Standard Deviation)
  30.7  (7.0)     25.5  (9.4)     23.0  (3.5)     26.3  (7.6)  
[1] Total Score ranging from 0 (worst) to 48 (best)



  Outcome Measures
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1.  Primary:   Safety Outcomes: Frequency of Adverse Events   [ Time Frame: 5 months ]

2.  Primary:   Serious Adverse Events   [ Time Frame: 5 months ]

3.  Primary:   Tolerability   [ Time Frame: 5 months ]

4.  Secondary:   Rate of Change in ALSFRS-R in Units/Month   [ Time Frame: Over 5 months ]

5.  Secondary:   Biomarkers of Body Composition and Lipid Metabolism   [ Time Frame: 5 months follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anne-Marie Wills
Organization: Massachusetts General Hospital
phone: 855-644-6387
e-mail: awills@partners.org


Publications:

Publications automatically indexed to this study:

Responsible Party: Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00983983     History of Changes
Other Study ID Numbers: MDA136152, 2009-P-001132
Study First Received: September 23, 2009
Results First Received: September 16, 2014
Last Updated: February 11, 2015
Health Authority: United States: Institutional Review Board