Dietary Approach to Improving QoL in ALS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- change in fat mass (in kilograms) from baseline over 12 weeks
Study Overview
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.
Detailed Description
Study visits: 3 total over 12 weeks. Screening prior to enrollment will include consent to complete three 24-hour dietary recalls prior to the first study visit.
Visit 0. Subject will be seen in the University of Iowa Hospitals and Clinics (UIHC) Neurology Clinic, prevention intervention center or clinical research unit to review the consent, answer questions and sign the consent.
Subjects will provide phone numbers and best times for the dietitian to call for the dietary recall interviews and will be given a 2-dimensional food portion booklet to assist with reporting amount of food eaten.
Letters and a copy of the study consent will be sent to eligible ALS patients from the UIHC ALS clinic with follow up calls as previously descried.
Questions will be answered, the consent will be reviewed. If the patient wants to participate in the study, a Visit 1 will be scheduled and permission to complete the 24 hour dietary recalls will be obtained.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Modified Paleolithic diet (Other)
Outcomes
Primary Outcomes
change in fat mass (in kilograms) from baseline over 12 weeks
Time Frame: 12 weeks
Bio-electrical impedance measurement of body composition
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 total body weight from baseline over 12 weeks.
Time Frame: 12 weeks
body weight (kilograms)
change in fat-free mass (in kilograms) from baseline over 12 weeks
Time Frame: 12 weeks
Bio-electrical impedance measurement of body composition
Secondary Outcomes
- change in breathing function over 12 weeks(12 weeks)
- change in motor function over 12 weeks(12 weeks)
- Change in fatigue level(12 weeks)
Investigators
Terry L. Wahls
Clinical Professor of Medicine, Principal Investigator
University of Iowa