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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-P-001132 |
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| Name | Class |
|---|---|
| Muscular Dystrophy Association | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High fat/high calorie | Experimental | High fat/high calorie diet: Oxepa |
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| High calorie | Active Comparator | High calorie diet: Jevity 1.5 |
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| Control | Placebo Comparator | Control diet: Jevity 1.0 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxepa | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes: Frequency of Adverse Events | 5 months | |
| Serious Adverse Events | SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | 5 months |
| Tolerability | Number of participants who completed the study on their assigned study intervention. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Over 5 months |
| Biomarkers of Body Composition and Lipid Metabolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie A Wills, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute/St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8604660 | Background | 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. | |
| 16909026 | Background | 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. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Jevity 1.5 | Dietary 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 1.0 | Dietary 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. |
|
| 5 months follow-up |
| University of California at Irvine |
| Irvine |
| California |
| 92868 |
| United States |
| California Pacific Medical Center, University of California at San Francisco | San Francisco | California | 94120 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Neurology Clinical Trials Unit, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | United States |
| Carolinas Medical Center Neuromuscular/ALS-MDA Center | Charlotte | North Carolina | 28207 | United States |
| Oregan Health and Science University | Portland | Oregon | 97239 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19107 | United States |
| Methodist Neurological Institute | Houston | Texas | 77030 | United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| 11522556 | Background | 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. |
| 18300717 | Background | 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. |
| 16648143 | Background | 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. |
| 17114821 | Background | 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. |
| 15263088 | Background | 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. |
| 24582471 | Result | 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. |
| 21607987 | Derived | 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. |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) | Total Score ranging from 0 (worst) to 48 (best) | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale/month | Over 5 months |
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| Secondary | Biomarkers of Body Composition and Lipid Metabolism | Not Posted | 5 months follow-up | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Safety Outcomes: Frequency of Adverse Events | Posted | Number | Total Number of Adverse Events | 5 months |
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| Primary | Serious Adverse Events | SAE were defined using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. | Posted | Number | Number of Serious Adverse Events | 5 months |
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| Primary | Tolerability | Number of participants who completed the study on their assigned study intervention. | The number of participants who received the study diet (4 participants withdrew consent prior to receiving study intervention). | Posted | Number | participants | 5 months |
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Participants were followed for adverse events for 30 days after stopping study diet.
Safety analyses were performed on all participants who initiated study diets.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 6 | 6 | 6 | ||
| EG001 | 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. | 0 | 8 | 8 | 8 | ||
| EG002 | 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. | 4 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Stomach Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection-Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Elevated Troponin | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight Loss | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Bloating/Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Detached feeding tube/Replacement of feeding tube | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection-Urinary Tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection-Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Fall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain-Abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dyspnea-Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough/Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pleural Effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Head Cold/Sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Sore Throat | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Blocked Foley Catheter | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| "Right arm and leg puffiness" | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight Gain | General disorders | CTCAE (3.0) | Systematic Assessment | While this was the pre-specified purpose of the study, some sites included this as an AE. |
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| Abrasion | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Drooling | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dry Mouth | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Esophagitis/Esophageal Spasm | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Burping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Borborygmi | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Increased Bowel Movements | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Abdominal Fullness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Upset Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Protein-Calorie Malnutrition | General disorders | CTCAE (3.0) | Systematic Assessment | Diagnosed based upon albumin levels during a hospital admission |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection-Lung (Pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Oral/Perioral Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| C. difficile Infection | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Extremity Weakness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Weakness-Trunk | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neck Muscle Soreness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain-Abdomen/Stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain at PEG site | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne-Marie Wills | Massachusetts General Hospital | 855-644-6387 | awills@partners.org |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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