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Recruitment Status : Withdrawn (not funded)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
|Condition or disease||Intervention/treatment||Phase|
|Diet Modification Amyotrophic Lateral Sclerosis||Other: Modified Paleolithic diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Change in total body weight from baseline over 12 weeks. [ Time Frame: 12 weeks ]body weight (kilograms)
- Change in Body Mass Index from baseline over 12 weeks. [ Time Frame: 12 weeks ]body weight (in kilograms) divided by height square (in meters)
- change in fat mass (in kilograms) from baseline over 12 weeks [ Time Frame: 12 weeks ]Bio-electrical impedance measurement of body composition
- change in fat-free mass (in kilograms) from baseline over 12 weeks [ Time Frame: 12 weeks ]Bio-electrical impedance measurement of body composition
- change in motor function over 12 weeks [ Time Frame: 12 weeks ]Grip strength
- change in breathing function over 12 weeks [ Time Frame: 12 weeks ]Forced Expiratory Volume
- 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.
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
|Principal Investigator:||Terry L Wahls, MD||University of Iowa|