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Trial record 3 of 5 for:    TERRY WAHLS
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Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT03659422
Recruitment Status : Withdrawn (not funded)
First Posted : September 6, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Muscular Dystrophy Association
Information provided by (Responsible Party):
Terry L. Wahls, University of Iowa

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diet Modification Amyotrophic Lateral Sclerosis Other: Modified Paleolithic diet Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Approach to Improving QoL in ALS
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Intervention Arm
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in total body weight from baseline over 12 weeks. [ Time Frame: 12 weeks ]
    body weight (kilograms)

  2. Change in Body Mass Index from baseline over 12 weeks. [ Time Frame: 12 weeks ]
    body weight (in kilograms) divided by height square (in meters)

  3. change in fat mass (in kilograms) from baseline over 12 weeks [ Time Frame: 12 weeks ]
    Bio-electrical impedance measurement of body composition

  4. change in fat-free mass (in kilograms) from baseline over 12 weeks [ Time Frame: 12 weeks ]
    Bio-electrical impedance measurement of body composition


Secondary Outcome Measures :
  1. change in motor function over 12 weeks [ Time Frame: 12 weeks ]
    Grip strength

  2. change in breathing function over 12 weeks [ Time Frame: 12 weeks ]
    Forced Expiratory Volume

  3. Change in fatigue level [ Time Frame: 12 weeks ]
    Fatigue Severity Scale is used. scale has 9 questions, each could range from 1 to 7. Sum responses and divide by number of items for scale score. Higher score indicates more disability.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Clinically significant liver, kidney, or heart disease
  2. Taking insulin or Coumadin
  3. Ventilator dependence
  4. Psychiatric disorder making dietary compliance difficult (e.g. schizophrenia)
  5. Unwillingness to have blood specimens collected
  6. Dysphagia present
  7. Greater than two years since onset of ALS symptoms
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03659422


Sponsors and Collaborators
Terry L. Wahls
Muscular Dystrophy Association
Investigators
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Principal Investigator: Terry L Wahls, MD University of Iowa
More Information
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Publications:

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Responsible Party: Terry L. Wahls, Clinical Professor of Medicine, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03659422    
Other Study ID Numbers: 201802746
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases