Clinical trial NCT03659422: Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis
Official title: Dietary Approach to Improving QoL in ALS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diet Modification
Amyotrophic Lateral Sclerosis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Muscular Dystrophy Association
First posted: 2018-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Height and weight will be documented from the participant clinic visits (neurology and primary care if needed) to obtain at least 2 weights and a height obtained in a clinic setting in the prior 6 months to calculate a slope of projected weight loss per month and a projected weight loss and muscle mass loss that may be observed at visit 2.

Visit 1. Subjects will be asked to fast for 12 hours prior to visit. Urine specific gravity will be obtained. The target is 1.004 to 1.028. If the urine is too dilute, the patient is to stop drinking and the other tests will be obtained and urine specific gravity will be repeated. The urine specific gravity that is noted that is within the range -- will be the target specific gravity for future BIS tests (ideally within .005). Patients are asked to report with the same level of hydration for future tests. Resting energy expenditure, forced vitality capacity and hand grip test will be completed. Fasting blood specimens and vital signs will be obtained. Subjects will be provided with a snack (or asked to bring a snack). Questionnaires will be completed. Subjects will be educated how the subject's personal family history (genetic vulnerability) may have interacted with the patient's unique DNA and lifetime of diet, lifestyle choices and environmental exposures to contributed to the participants' current health circumstances. The subject will be instructed on a stress-reducing practice on mindfulness and the subject will do a practice session of mindfulness. The participant will be taught the study diet by the intervention dietitian. A diet checklist that offers guidance to the subject in the form of prompts to eat the foods that are recommended and to avoid those that are not recommended will be provided. The subject and their adult companion will be given a study-compliant meal and will practice recording the meal in the diet checklist to facilitate the learning of the principles of the study diet and how to use the daily diet checklist. The subject and adult companion will be instructed on mindful eating.

The study visit will take approximately 5 to 6 hours. The subject will be given a 'loaner' food blending machine to use to make smoothies and soups that are compliant with the study diet. The subject will be asked to add 20 grams of bone broth protein powder and consume that in a study compliant smoothie or warm beverage each day to increase protein intake in a food or beverage item that does not require chewing (such as a smoothie or soup.

After the study visit:

Subjects will work by telephone with the study dietitian as they implement the study diet and stress reducing practice. The subject will be called 2 to 3 days after the visit by the study dietitian to review the study diet and answer questions. The dietitian will call again in one week to review the study diet with the study subject and ask how the participant is managing the diet. The dietitian will ask the participant if they are willing to continue on the study diet for the remainder of the study which is called the intervention phase of the study. If he participant is willing to continue the study diet, they will begin adding the various vitamins and supplements according to schedule in the diet checklist. If the participant does not wish to continue the study diet, the coaching calls will stop. Even if the participant resumes their usual diet, the participant will still come in for the end of study visit 3 at 12 weeks. The participant will not come back for 12 week visit.

Visit 2: 6 weeks.

Subjects will be asked to fast for 12 hours prior to visit. The patient will be weighed. Urine specific gravity will be obtained. The target urine specific gravity for the patient future BIS tests (ideally within .005) from the first BIS will be identified. A urine sample will be obtained The urine specific gravity will be obtained and compared to the target value. If the urine is too dilute, the patient is to stop drinking and the other tests will be obtained and urine specific gravity will be repeated in 1 hour.

The changes in muscle mass between visit 1 and visit 2 will be calculated and compared to the projected muscle mass loss. If the participant has lost more muscle mass than was projected, the study dietitian will instruct the participant on strategies to increase calories and protein while following the study diet. In addition, the participant will be asked to increase the intake of bone broth protein to 40 grams per day.

This visit will take 3 hours.

Visit 3: End of Study visit at 12 weeks. Participants will return the blending machine. The target urine specific gravity for the patient future BIS tests (ideally within .005) from the first BIS will be identified. A urine sample will be obtained The urine specific gravity will be obtained and compared to the target value. If the urine is too dilute, the patient is to stop drinking and the other tests will be obtained and urine specific gravity will be repeated in 1 hour. Patients are asked to report with the same level of hydration for future tests.

Resting energy expenditure, forced vitality capacity and BIS will be completed. Fasting blood specimens and vital signs will be obtained. Subjects will be able to eat a snack. The hand grip test will be completed. Questionnaires will be completed. The study team will answer questions about the study. Three 24 hour recalls will be completed in the week before and or the week after the end of study visit.

The changes in muscle mass between visit 1 and visit 2 will be calculated and compared to the projected muscle mass loss. The participant will be informed if the muscle mass is greater than projected and will be informed of strategies to increase calorie and protein intake.

The study visit will take approximately 2 to 3 hours.

Eligibility 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

Primary outcomes:
measure: Change in total body weight from baseline over 12 weeks.
timeFrame: 12 weeks
measure: Change in Body Mass Index from baseline over 12 weeks.
timeFrame: 12 weeks
measure: change in fat mass (in kilograms) from baseline over 12 weeks
timeFrame: 12 weeks
measure: change in fat-free mass (in kilograms) from baseline over 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: change in motor function over 12 weeks
timeFrame: 12 weeks
measure: change in breathing function over 12 weeks
timeFrame: 12 weeks
measure: Change in fatigue level
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Terry L Wahls, MD
role: PRINCIPAL_INVESTIGATOR
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