Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis

NCT03659422 | Withdrawn DMC

• 1 other identifier: 201802746
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

We have had reports of an individual who utilized a modified Paleolithic diet and vitamin/ supplement program as part of his approach to managing ALS related symptoms. This individual has experienced stability in his ALS functional rating score and stable to improving strength over an 18 month period. There are also anecdotal reports of ALS patients who have utilized a dietary approach based on a Paleolithic eating plan of improved function. This is a safety study. We will be assessing if patients can implement the proposed modified Paleolithic diet (Wahls Elimination), if lean muscle mass is maintained on the study diet, and what changes occur in the ALS functional symptoms and quality of life.

Conditions

Diet Modification; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (4)

• Change in total body weight from baseline over 12 weeks.

  body weight (kilograms)

  12 weeks

• Change in Body Mass Index from baseline over 12 weeks.

  body weight (in kilograms) divided by height square (in meters)

  12 weeks

• change in fat mass (in kilograms) from baseline over 12 weeks

  Bio-electrical impedance measurement of body composition

  12 weeks

• change in fat-free mass (in kilograms) from baseline over 12 weeks

  Bio-electrical impedance measurement of body composition

  12 weeks

Secondary Outcomes (3)

• change in motor function over 12 weeks

  12 weeks

• change in breathing function over 12 weeks

  12 weeks

• Change in fatigue level

  12 weeks

Study Arms (1)

Intervention Arm

OTHER

Modified Paleolithic diet and vitamin/ supplement program was part of previous approaches to managing ALS related symptoms over an 18 month period. This is a safety study. We will be assessing if patients can implement the proposed modified Paleolithic diet (Wahls Elimination), if lean muscle mass is maintained on the study diet, and what changes occur in the ALS functional symptoms and quality of life.

Other: Modified Paleolithic diet

Interventions

Modified Paleolithic diet OTHER

The diet eliminates legumes, grains and nightshades (as opposed to the Paleolithic diet) and is higher in vegetable and fruit intake and in omega-3 fatty rich foods.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically possible, clinically probable (with or without laboratory support), or clinically definite ALS (using the revised El Escorial Criteria)
• Ability to prepare, or have prepared for them, home-cooked meals
• Age between 18 and 80 years
• Followed by ALS clinic at the University of Iowa
• Willingness to adopt the study diet

You may not qualify if:

• Clinically significant liver, kidney, or heart disease
• Taking insulin or Coumadin
• Ventilator dependence
• Psychiatric disorder making dietary compliance difficult (e.g. schizophrenia)
• Unwillingness to have blood specimens collected
• Dysphagia present
• Greater than two years since onset of ALS symptoms

Sponsors & Collaborators

• Terry L. Wahls: lead
• Muscular Dystrophy Association: collaborator

Related Publications (30)

• Milonas I. Amyotrophic lateral sclerosis: an introduction. J Neurol. 1998 Aug;245 Suppl 2:S1-3. doi: 10.1007/s004150050640.

  PMID: 9747926 BACKGROUND

• Talbott EO, Malek AM, Lacomis D. The epidemiology of amyotrophic lateral sclerosis. Handb Clin Neurol. 2016;138:225-38. doi: 10.1016/B978-0-12-802973-2.00013-6.

  PMID: 27637961 BACKGROUND

• Wang MD, Little J, Gomes J, Cashman NR, Krewski D. Identification of risk factors associated with onset and progression of amyotrophic lateral sclerosis using systematic review and meta-analysis. Neurotoxicology. 2017 Jul;61:101-130. doi: 10.1016/j.neuro.2016.06.015. Epub 2016 Jul 1.

  PMID: 27377857 BACKGROUND

• Okamoto K, Kihira T, Kobashi G, Washio M, Sasaki S, Yokoyama T, Miyake Y, Sakamoto N, Inaba Y, Nagai M. Fruit and vegetable intake and risk of amyotrophic lateral sclerosis in Japan. Neuroepidemiology. 2009;32(4):251-6. doi: 10.1159/000201563. Epub 2009 Feb 11.

  PMID: 19209004 BACKGROUND

• Jin Y, Oh K, Oh SI, Baek H, Kim SH, Park Y. Dietary intake of fruits and beta-carotene is negatively associated with amyotrophic lateral sclerosis risk in Koreans: a case-control study. Nutr Neurosci. 2014 Apr;17(3):104-8. doi: 10.1179/1476830513Y.0000000071. Epub 2013 Nov 26.

  PMID: 23710627 BACKGROUND

• Fitzgerald KC, O'Reilly EJ, Falcone GJ, McCullough ML, Park Y, Kolonel LN, Ascherio A. Dietary omega-3 polyunsaturated fatty acid intake and risk for amyotrophic lateral sclerosis. JAMA Neurol. 2014 Sep;71(9):1102-10. doi: 10.1001/jamaneurol.2014.1214.

  PMID: 25023276 BACKGROUND

• Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1994 Jul;124 Suppl:14-9. doi: 10.1016/0022-510x(94)90171-6.

  PMID: 7807136 BACKGROUND

• Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1993 Sep;118(2):169-74. doi: 10.1016/0022-510x(93)90106-9.

  PMID: 8229065 BACKGROUND

• Brown KJ, Jewells V, Herfarth H, Castillo M. White matter lesions suggestive of amyotrophic lateral sclerosis attributed to celiac disease. AJNR Am J Neuroradiol. 2010 May;31(5):880-1. doi: 10.3174/ajnr.A1826. Epub 2009 Nov 12.

  PMID: 19910450 BACKGROUND

• Gadoth A, Nefussy B, Bleiberg M, Klein T, Artman I, Drory VE. Transglutaminase 6 Antibodies in the Serum of Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. 2015 Jun;72(6):676-81. doi: 10.1001/jamaneurol.2015.48.

  PMID: 25867286 BACKGROUND

• Rao TV, Tharakan JK, Jacob PC. Systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. Clin Neuropathol. 2004 May-Jun;23(3):99-101.

  PMID: 15200286 BACKGROUND

• Maldonado ME, Williams RC Jr, Adair JC, Hart BL, Gregg L, Sibbitt WL Jr. Neuropsychiatric systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. J Rheumatol. 2002 Mar;29(3):633-5.

  PMID: 11908583 BACKGROUND

• Turner MR, Goldacre R, Ramagopalan S, Talbot K, Goldacre MJ. Autoimmune disease preceding amyotrophic lateral sclerosis: an epidemiologic study. Neurology. 2013 Oct 1;81(14):1222-5. doi: 10.1212/WNL.0b013e3182a6cc13. Epub 2013 Aug 14.

  PMID: 23946298 BACKGROUND

• Park Y, Park J, Kim Y, Baek H, Kim SH. Association between nutritional status and disease severity using the amyotrophic lateral sclerosis (ALS) functional rating scale in ALS patients. Nutrition. 2015 Nov-Dec;31(11-12):1362-7. doi: 10.1016/j.nut.2015.05.025. Epub 2015 Jul 6.

  PMID: 26429656 BACKGROUND

• Bouteloup C, Desport JC, Clavelou P, Guy N, Derumeaux-Burel H, Ferrier A, Couratier P. Hypermetabolism in ALS patients: an early and persistent phenomenon. J Neurol. 2009 Aug;256(8):1236-42. doi: 10.1007/s00415-009-5100-z. Epub 2009 Mar 22.

  PMID: 19306035 BACKGROUND

• Roubeau V, Blasco H, Maillot F, Corcia P, Praline J. Nutritional assessment of amyotrophic lateral sclerosis in routine practice: value of weighing and bioelectrical impedance analysis. Muscle Nerve. 2015 Apr;51(4):479-84. doi: 10.1002/mus.24419. Epub 2015 Feb 24.

  PMID: 25130859 BACKGROUND

• Ngo ST, Steyn FJ, McCombe PA. Body mass index and dietary intervention: implications for prognosis of amyotrophic lateral sclerosis. J Neurol Sci. 2014 May 15;340(1-2):5-12. doi: 10.1016/j.jns.2014.02.035. Epub 2014 Mar 3.

  PMID: 24629478 BACKGROUND

• Salvioni CC, Stanich P, Almeida CS, Oliveira AS. Nutritional care in motor neurone disease/ amyotrophic lateral sclerosis. Arq Neuropsiquiatr. 2014 Feb;72(2):157-63. doi: 10.1590/0004-282X20130185.

  PMID: 24604371 BACKGROUND

• Fitzgerald KC, O'Reilly EJ, Fondell E, Falcone GJ, McCullough ML, Park Y, Kolonel LN, Ascherio A. Intakes of vitamin C and carotenoids and risk of amyotrophic lateral sclerosis: pooled results from 5 cohort studies. Ann Neurol. 2013 Feb;73(2):236-45. doi: 10.1002/ana.23820. Epub 2013 Jan 29.

  PMID: 23362045 BACKGROUND

• Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.

  PMID: 24476345 BACKGROUND

• Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.

  PMID: 28394724 BACKGROUND

• Coyne N, Correnti D. Effectiveness of motivational interviewing to improve chronic condition self-management: what does the research show us? Home Healthc Nurse. 2014 Jan;32(1):56-63. doi: 10.1097/NHH.0000000000000001.

  PMID: 24326477 BACKGROUND

• Vansteenkiste M, Williams GC, Resnicow K. Toward systematic integration between self-determination theory and motivational interviewing as examples of top-down and bottom-up intervention development: autonomy or volition as a fundamental theoretical principle. Int J Behav Nutr Phys Act. 2012 Mar 2;9:23. doi: 10.1186/1479-5868-9-23.

  PMID: 22385828 BACKGROUND

• Inam S, Vucic S, Brodaty NE, Zoing MC, Kiernan MC. The 10-metre gait speed as a functional biomarker in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2010 Dec;11(6):558-61. doi: 10.3109/17482961003792958. Epub 2010 Jun 2.

  PMID: 20515425 BACKGROUND

• Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.

  PMID: 21652563 BACKGROUND

• Kaufmann P, Levy G, Thompson JL, Delbene ML, Battista V, Gordon PH, Rowland LP, Levin B, Mitsumoto H. The ALSFRSr predicts survival time in an ALS clinic population. Neurology. 2005 Jan 11;64(1):38-43. doi: 10.1212/01.WNL.0000148648.38313.64.

  PMID: 15642901 BACKGROUND

• Simmons Z, Felgoise SH, Bremer BA, Walsh SM, Hufford DJ, Bromberg MB, David W, Forshew DA, Heiman-Patterson TD, Lai EC, McCluskey L. The ALSSQOL: balancing physical and nonphysical factors in assessing quality of life in ALS. Neurology. 2006 Nov 14;67(9):1659-64. doi: 10.1212/01.wnl.0000242887.79115.19.

  PMID: 17101900 BACKGROUND

• Chio A, Gauthier A, Calvo A, Ghiglione P, Mutani R. Caregiver burden and patients' perception of being a burden in ALS. Neurology. 2005 May 24;64(10):1780-2. doi: 10.1212/01.WNL.0000162034.06268.37.

  PMID: 15911811 BACKGROUND

• Bisht B, Darling WG, Shivapour ET, Lutgendorf SK, Snetselaar LG, Chenard CA, Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27.

  PMID: 30728736 BACKGROUND

• Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.

  PMID: 30050374 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Terry L Wahls, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Medicine, Principal Investigator

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: September 6, 2018
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share