Hypercaloric enteral nutrition in patients with amyotrophic lateral sclerosis: A randomised, double-blind, placebo-controlled phase 2 trial

The Lancet

Volumn 383, Issue 9934, 2014, Pages 2065-2072

  Wills, Anne Marie ^a,d   Hubbard, Jane ^b   Macklin, Eric A ^c,d   Glass, Jonathan ^e   Tandan, Rup ^f   Simpson, Ericka P ^g   Brooks, Benjamin ^h   Gelinas, Deborah ⁱ   Mitsumoto, Hiroshi ^j   Mozaffar, Tahseen ^k   Hanes, Gregory P ^l   Ladha, Shafeeq S ^m   Heiman Patterson, Terry ⁿ   Katz, Jonathan ^o   Lou, Jau Shin ^p   Mahoney, Katy ^a   Grasso, Daniela ^a   Lawson, Robert ^a   Yu, Hong ^a   Cudkowicz, Merit ^a  

^a Neurological Clinical Research Institute   (United States)

^b MASSACHUSETTS GENERAL HOSPITAL   (United States)

^c Biostatistics Center   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

^e EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF VERMONT   (United States)

^g HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

^h CAROLINAS MEDICAL CENTER   (United States)

ⁱ Saint Mary's Health Care   (United States)

^j New York Presbyterian Hospital Columbia University Medical Center   (United States)

^k UNIVERSITY OF CALIFORNIA   (United States)

^l SARASOTA MEMORIAL HOSPITAL   (United States)

^m BARROW NEUROLOGICAL INSTITUTE   (United States)

ⁿ DREXEL UNIVERSITY   (United States)

^o UNIVERSITY OF CALIFORNIA   (United States)

^p OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL PAIN; ABRASION; ADULT; ADVERSE OUTCOME; ALLERGIC RHINITIS; ALLERGY; AMYOTROPHIC LATERAL SCLEROSIS; ARTICLE; BLOATING; CALORIC INTAKE; CARBOHYDRATE DIET; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DYSPEPSIA; DYSPNEA; ENTERIC FEEDING; FALLING; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HUMAN; HYPOXIA; LIMB PAIN; LIPID DIET; MALE; MORTALITY; MULTICENTER STUDY; MUSCLE WEAKNESS; NECK PAIN; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PULMONARY ASPIRATION; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; TREATMENT DURATION; TREATMENT WITHDRAWAL; UNITED STATES; URINARY TRACT INFECTION; WEIGHT CHANGE;

ADULT; AGED; AMYOTROPHIC LATERAL SCLEROSIS; CHOLESTEROL; DIET, HIGH-FAT; DOUBLE-BLIND METHOD; ENERGY INTAKE; ENTERAL NUTRITION; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PILOT PROJECTS;

EID: 84902314640     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(14)60222-1     Document Type: Article

References (31)

1. Kiernan MC, Vucic S, Cheah BC, et al. Amyotrophic lateral sclerosis. Lancet 2011; 377: 942-55.
2. Kasarskis EJ, Neville HE. Management of ALS: nutritional care. Neurology 1996; 47 (suppl 2): S118-20.
3. Dupuis L, Pradat P-F, Ludolph AC, Loeffler J-P. Energy metabolism in amyotrophic lateral sclerosis. Lancet Neurol 2011; 10: 75-82.
4. Genton L, Viatte V, Janssens JP, Heritier AC, Pichard C. Nutritional state, energy intakes and energy expenditure of amyotrophic lateral sclerosis (ALS) patients. Clin Nutr 2011; 30: 553-59.
5. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2009; 73: 1218-26.
6. Andersen PM, Abrahams S, Borasio GD, et al. EFNS guidelines on the clinical management of amyotrophic lateral sclerosis (MALS)-revised report of an EFNS task force. Eur J Neurol 2012; 19: 360-75.
7. Greenwood DI. Nutrition management of amyotrophic lateral sclerosis. Nutr Clin Pract 2013; 28: 392-99.
8. Nau KL, Bromberg MB, Forshew DA, Katch VL. Individuals with amyotrophic lateral sclerosis are in caloric balance despite losses in mass. J Neurol Sci 1995; 129 (suppl): 47-49.
9. 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; 63: 130-37
10. Desport JC, Preux PM, Truong TC, Vallat JM, Sautereau D, Couratier P. Nutritional status is a prognostic factor for survival in ALS patients. Neurology 1999; 53: 1059-63.
11. 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; 44: 20-24.
12. Reich-Slotky R, Andrews J, Cheng B, et al. Body mass index (BMI) as predictor of ALSFRS-R score decline in ALS patients. Amyotroph Lateral Scler Frontotemporal Degener 2013; 14: 212-16.
13. Gallo V, Wark PA, Jenab M, et al. Prediagnostic body fat and risk of death from amyotrophic lateral sclerosis: the EPIC cohort. Neurology 2013; 80: 829-38.
14. O'Reilly EJ, Wang H, Weisskopf MG, et al. Premorbid body mass index and risk of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener 2013; 14: 205-11.
15. 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 USA 2004; 101: 11159-64.
16. Mattson MP, Cutler RG, Camandola S. Energy intake and amyotrophic lateral sclerosis. Neuromolecular Med 2007; 9: 17-20.
17. Pedersen WA, Mattson MP. No benefit of dietary restriction on disease onset or progression in amyotrophic lateral sclerosis Cu/Zn-superoxide dismutase mutant mice. Brain Res 1999; 833: 117-20.
18. Brooks BR. El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis. Subcommittee on Motor Neuron Diseases/Amyotrophic Lateral Sclerosis of the World Federation of Neurology Research Group on Neuromuscular Diseases and the El Escorial "Clinical limits of amyotrophic lateral sclerosis" workshop contributors. J Neurol Sci 1994; 124 (suppl): 96-107.
19. Trumbo P, Schlicker S, Yates AA, Poos M. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc 2002; 102: 1621-30.
20. Bouchard C, Tremblay A, Leblanc C, Lortie G, Savard R, Theriault G. A method to assess energy expenditure in children and adults. Am J Clin Nutr 1983; 37: 461-67.
21. Otten J, Pitzi-Hellwig J, Meyers L. Dietary reference intakes: the essential guide to nutrient requirements. Washington DC: National Academies Press, 2006.
22. Shaw AS, Ampong MA, Rio A, et al. Survival of patients with ALS following institution of enteral feeding is related to pre-procedure oximetry: a retrospective review of 98 patients in a single centre. Amyotroph Lateral Scler 2006; 7: 16-21.
23. Berry JD, Miller R, Moore DH, et al. The Combined Assessment of Function and Survival (CAFS): a new endpoint for ALS clinical trials. Amyotroph Lateral Scler Frontotemporal Degener; 14: 162-68.
24. Dupuis L, Corcia P, Fergani A, et al. Dyslipidemia is a protective factor in amyotrophic lateral sclerosis. Neurology 2008; 70: 1004-09.
25. Aldrich TK. Nutritional factors in the pathogenesis and therapy of respiratory insufficiency in neuromuscular diseases. Monaldi Arch Chest Dis 1993; 48: 327-30.
26. Dorst J, Cypionka J, Ludolph AC. High-caloric food supplements in the treatment of amyotrophic lateral sclerosis: a prospective interventional study. Amyotroph Lateral Scler Frontotemporal Degener 2013; 14: 533-36.
27. Silva LB, Mourao LF, Silva AA, et al. Effect of nutritional supplementation with milk whey proteins in amyotrophic lateral sclerosis patients. Arq Neuropsiquiatr 2010; 68: 263-68.
28. Pontes-Arruda A, Aragao AM, Albuquerque JD. Effects of enteral feeding with eicosapentaenoic acid, gamma-linolenic acid, and antioxidants in mechanically ventilated patients with severe sepsis and septic shock. Crit Care Med 2006; 34: 2325-33.
29. Ichihara N, Namba K, Ishikawa-Takata K, et al. Energy requirement assessed by doubly-labeled water method in patients with advanced amyotrophic lateral sclerosis managed by tracheotomy positive pressure ventilation. Amyotroph Lateral Scler 2012; 13: 544-49.
30. Kasarskis EJ, Mendiondo MS, Wells S, et al. The ALS Nutrition/NIPPV Study: design, feasibility, and initial results. Amyotroph Lateral Scler 2011; 12: 17-25.
31. Fearon K, Strasser F, Anker SD, et al. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol 2011; 12: 489-95.