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Trial record 97 of 677 for:    amyotrophic lateral sclerosis

High Fat/High Calorie Trial in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00983983
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Anne-Marie Alexandra Wills, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Interventions Dietary Supplement: Oxepa
Dietary Supplement: Jevity 1.5
Dietary Supplement: Jevity 1.0
Enrollment 28
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title High Fat/High Calorie High Calorie Control
Hide Arm/Group Description

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 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 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.

Period Title: Overall Study
Started 8 9 7
Completed 6 8 6
Not Completed 2 1 1
Arm/Group Title High Fat/High Calorie High Calorie/High Carbohydrate Control Total
Hide Arm/Group Description

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 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 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 of all reporting groups
Overall Number of Baseline Participants 8 9 7 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 7 participants 24 participants
64.0  (6.9) 57.5  (15.4) 63.2  (9.4) 61.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 7 participants 24 participants
Female
5
  62.5%
5
  55.6%
1
  14.3%
11
  45.8%
Male
3
  37.5%
4
  44.4%
6
  85.7%
13
  54.2%
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants 9 participants 7 participants 24 participants
30.7  (7.0) 25.5  (9.4) 23.0  (3.5) 26.3  (7.6)
[1]
Measure Description: Total Score ranging from 0 (worst) to 48 (best)
1.Primary Outcome
Title Safety Outcomes: Frequency of Adverse Events
Hide Description [Not Specified]
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Fat/High Calorie High Calorie Control
Hide Arm/Group Description:

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 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 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.

Overall Number of Participants Analyzed 8 9 7
Measure Type: Number
Unit of Measure: Total Number of Adverse Events
49 24 42
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Calorie, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Serious Adverse Events
Hide Description SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Fat/High Calorie High Calorie Control
Hide Arm/Group Description:

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 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 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.

Overall Number of Participants Analyzed 8 9 7
Measure Type: Number
Unit of Measure: Number of Serious Adverse Events
3 0 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Calorie, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Primary Outcome
Title Tolerability
Hide Description Number of participants who completed the study on their assigned study intervention.
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention).
Arm/Group Title High Fat/High Calorie High Calorie Control
Hide Arm/Group Description:

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 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 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.

Overall Number of Participants Analyzed 6 8 6
Measure Type: Number
Unit of Measure: participants
5 7 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Calorie, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Rate of Change in ALSFRS-R in Units/Month
Hide Description Rate of change in the ALS Functional Rating Scale-Revised, calculated in units/month. Negative numbers refer to worsening over time.
Time Frame Over 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Fat/High Calorie High Calorie/High Carbohydrate Control
Hide Arm/Group Description:

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 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 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.

Overall Number of Participants Analyzed 6 8 6
Mean (95% Confidence Interval)
Unit of Measure: units on a scale/month
-1.54
(-2.36 to -0.73)
-1.07
(-1.71 to -0.42)
-2.17
(-3.24 to -1.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Calorie/High Carbohydrate, Control
Comments Change over time in the ALSFRS-R was analyzed using random-slopes models
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Biomarkers of Body Composition and Lipid Metabolism
Hide Description [Not Specified]
Time Frame 5 months follow-up
Outcome Measure Data Not Reported
Time Frame Participants were followed for adverse events for 30 days after stopping study diet.
Adverse Event Reporting Description Safety analyses were performed on all participants who initiated study diets.
 
Arm/Group Title High Fat/High Calorie High Calorie/High Carbohydrate Control
Hide Arm/Group Description

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 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 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.

All-Cause Mortality
High Fat/High Calorie High Calorie/High Carbohydrate Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Fat/High Calorie High Calorie/High Carbohydrate Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      0/8 (0.00%)      4/6 (66.67%)    
Gastrointestinal disorders       
Stomach Pain  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  2
Infections and infestations       
Infection-Lung  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Psychiatric disorders       
Depression  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea (shortness of breath)  1  2/6 (33.33%)  2 0/8 (0.00%)  0 1/6 (16.67%)  1
Aspiration  1  0/6 (0.00%)  0 0/8 (0.00%)  0 3/6 (50.00%)  4
Hypoxia  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Fat/High Calorie High Calorie/High Carbohydrate Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      8/8 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders       
Thrombocytopenia  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
"Right arm and leg puffiness"  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Cardiac disorders       
Atrial Fibrillation  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Elevated Troponin  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders       
Anorexia  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Constipation  1  3/6 (50.00%)  4 0/8 (0.00%)  0 0/6 (0.00%)  0
Diarrhea  1  4/6 (66.67%)  5 1/8 (12.50%)  1 3/6 (50.00%)  3
Bloating/Flatulence  1  1/6 (16.67%)  2 1/8 (12.50%)  1 3/6 (50.00%)  3
Dysphagia  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Detached feeding tube/Replacement of feeding tube  1  1/6 (16.67%)  1 1/8 (12.50%)  1 0/6 (0.00%)  0
Heartburn  1  1/6 (16.67%)  1 0/8 (0.00%)  0 1/6 (16.67%)  1
Nausea  1  1/6 (16.67%)  1 2/8 (25.00%)  2 1/6 (16.67%)  1
Pain-Abdomen  1  1/6 (16.67%)  1 1/8 (12.50%)  1 1/6 (16.67%)  1
Drooling  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Esophagitis/Esophageal Spasm  1  0/6 (0.00%)  0 1/8 (12.50%)  1 1/6 (16.67%)  1
Burping  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Borborygmi  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Increased Bowel Movements  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Abdominal Fullness  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Upset Stomach  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Hemorrhoids  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
C. difficile Infection  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Pain-Abdomen/Stomach  1  2/6 (33.33%)  2 1/8 (12.50%)  1 1/6 (16.67%)  1
Pain at PEG site  1  0/6 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0
General disorders       
Fatigue  1  1/6 (16.67%)  1 1/8 (12.50%)  1 2/6 (33.33%)  4
Insomnia  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Weight Loss  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Weight Gain  1 [1]  0/6 (0.00%)  0 1/8 (12.50%)  1 1/6 (16.67%)  1
Dry Mouth  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Protein-Calorie Malnutrition  1 [2]  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Immune system disorders       
Allergic Rhinitis  1  0/6 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0
Infections and infestations       
Infection-Urinary Tract  1  1/6 (16.67%)  1 1/8 (12.50%)  1 2/6 (33.33%)  2
Infection-Bronchus  1  1/6 (16.67%)  1 1/8 (12.50%)  1 0/6 (0.00%)  0
Head Cold/Sinusitis  1  1/6 (16.67%)  1 0/8 (0.00%)  0 1/6 (16.67%)  1
Sore Throat  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Infection-Lung (Pneumonia)  1  1/6 (16.67%)  1 0/8 (0.00%)  0 2/6 (33.33%)  2
Oral/Perioral Infection  1  2/6 (33.33%)  2 1/8 (12.50%)  1 0/6 (0.00%)  0
Cellulitis  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Fracture  1  0/6 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0
Fall  1  1/6 (16.67%)  1 1/8 (12.50%)  3 0/6 (0.00%)  0
Neck Muscle Soreness  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders       
Extremity Weakness  1  1/6 (16.67%)  1 1/8 (12.50%)  1 0/6 (0.00%)  0
Weakness-Trunk  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Dizziness  1  0/6 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0
Psychiatric disorders       
Depression  1  1/6 (16.67%)  1 0/8 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders       
Blocked Foley Catheter  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea-Shortness of Breath  1  2/6 (33.33%)  4 1/8 (12.50%)  1 1/6 (16.67%)  1
Cough/Congestion  1  1/6 (16.67%)  2 0/8 (0.00%)  0 0/6 (0.00%)  0
Pleural Effusion (non-malignant)  1  0/6 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders       
Abrasion  1  1/6 (16.67%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
While this was the pre-specified purpose of the study, some sites included this as an AE.
[2]
Diagnosed based upon albumin levels during a hospital admission
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
Layout table for Results Point of Contact information
Name/Title: Dr. Anne-Marie Wills
Organization: Massachusetts General Hospital
Phone: 855-644-6387
EMail: awills@partners.org
Other Publications:
Layout table for additonal information
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
First Submitted: September 23, 2009
First Posted: September 24, 2009
Results First Submitted: September 16, 2014
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015