NCT03659422|WithdrawnDMC
Study Stopped
not funded
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Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
July 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 12, 2018
Actual (reported)September 6, 2018
Actual (reported)July 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
change in motor function over 12 weeks
12 weeks
change in breathing function over 12 weeks
12 weeks
Change in fatigue level
12 weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Terry L Wahls, MD
University of Iowa
0 participants (actual enrollment reported by the registry).
First Submitted
April 12, 2018
First Posted
September 6, 2018
Study Start
July 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
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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.
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.
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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.
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Primary Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 14, 2019
Record last verified: 2019-06
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