Diet ModificationNCT03659422
Dietary Approach to Improving Quality of Life in Amyotrophic Lateral Sclerosis
A study testing Modified Paleolithic diet in people with Diet Modification and Amyotrophic Lateral Sclerosis, run by Terry L. Wahls.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diet Modification, Amyotrophic Lateral Sclerosis
- What is being tested?
- Modified Paleolithic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Dietary Approach to Improving QoL in ALS
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.
Read the 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.
- Conditions
- Diet Modification, Amyotrophic Lateral Sclerosis
- Being tested
- Modified Paleolithic diet
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Paleolithic dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | 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. Receives: Other: Modified Paleolithic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total body weight from baseline over 12 weeks.
body weight (kilograms)
Measured: 12 weeks
Change in Body Mass Index from baseline over 12 weeks.
body weight (in kilograms) divided by height square (in meters)
Measured: 12 weeks
change in fat mass (in kilograms) from baseline over 12 weeks
Bio-electrical impedance measurement of body composition
Measured: 12 weeks
change in fat-free mass (in kilograms) from baseline over 12 weeks
Bio-electrical impedance measurement of body composition
Measured: 12 weeks
Secondary outcomes (3)
change in motor function over 12 weeks
Grip strength
Measured: 12 weeks
change in breathing function over 12 weeks
Forced Expiratory Volume
Measured: 12 weeks
Change in fatigue level
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Collaborators
- Muscular Dystrophy Association
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659422
- Sponsor's protocol ID
- 201802746
- Status last verified
- Jun 2019
- First submitted
- 12 Apr 2018
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milonas I. Amyotrophic lateral sclerosis: an introduction. J Neurol. 1998 Aug;245 Suppl 2:S1-3. doi: 10.1007/s004150050640.
PubMed 9747926Talbott EO, Malek AM, Lacomis D. The epidemiology of amyotrophic lateral sclerosis. Handb Clin Neurol. 2016;138:225-38. doi: 10.1016/B978-0-12-802973-2.00013-6.
PubMed 27637961Wang MD, Little J, Gomes J, Cashman NR, Krewski D. Identification of risk factors associated with onset and progression of amyotrophic lateral sclerosis using systematic review and meta-analysis. Neurotoxicology. 2017 Jul;61:101-130. doi: 10.1016/j.neuro.2016.06.015. Epub 2016 Jul 1.
PubMed 27377857Okamoto K, Kihira T, Kobashi G, Washio M, Sasaki S, Yokoyama T, Miyake Y, Sakamoto N, Inaba Y, Nagai M. Fruit and vegetable intake and risk of amyotrophic lateral sclerosis in Japan. Neuroepidemiology. 2009;32(4):251-6. doi: 10.1159/000201563. Epub 2009 Feb 11.
PubMed 19209004Jin Y, Oh K, Oh SI, Baek H, Kim SH, Park Y. Dietary intake of fruits and beta-carotene is negatively associated with amyotrophic lateral sclerosis risk in Koreans: a case-control study. Nutr Neurosci. 2014 Apr;17(3):104-8. doi: 10.1179/1476830513Y.0000000071. Epub 2013 Nov 26.
PubMed 23710627Fitzgerald KC, O'Reilly EJ, Falcone GJ, McCullough ML, Park Y, Kolonel LN, Ascherio A. Dietary omega-3 polyunsaturated fatty acid intake and risk for amyotrophic lateral sclerosis. JAMA Neurol. 2014 Sep;71(9):1102-10. doi: 10.1001/jamaneurol.2014.1214.
PubMed 25023276Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1994 Jul;124 Suppl:14-9. doi: 10.1016/0022-510x(94)90171-6.
PubMed 7807136Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1993 Sep;118(2):169-74. doi: 10.1016/0022-510x(93)90106-9.
PubMed 8229065Brown KJ, Jewells V, Herfarth H, Castillo M. White matter lesions suggestive of amyotrophic lateral sclerosis attributed to celiac disease. AJNR Am J Neuroradiol. 2010 May;31(5):880-1. doi: 10.3174/ajnr.A1826. Epub 2009 Nov 12.
PubMed 19910450Gadoth A, Nefussy B, Bleiberg M, Klein T, Artman I, Drory VE. Transglutaminase 6 Antibodies in the Serum of Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. 2015 Jun;72(6):676-81. doi: 10.1001/jamaneurol.2015.48.
PubMed 25867286Rao TV, Tharakan JK, Jacob PC. Systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. Clin Neuropathol. 2004 May-Jun;23(3):99-101.
PubMed 15200286Maldonado ME, Williams RC Jr, Adair JC, Hart BL, Gregg L, Sibbitt WL Jr. Neuropsychiatric systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. J Rheumatol. 2002 Mar;29(3):633-5.
PubMed 11908583Turner MR, Goldacre R, Ramagopalan S, Talbot K, Goldacre MJ. Autoimmune disease preceding amyotrophic lateral sclerosis: an epidemiologic study. Neurology. 2013 Oct 1;81(14):1222-5. doi: 10.1212/WNL.0b013e3182a6cc13. Epub 2013 Aug 14.
PubMed 23946298Park Y, Park J, Kim Y, Baek H, Kim SH. Association between nutritional status and disease severity using the amyotrophic lateral sclerosis (ALS) functional rating scale in ALS patients. Nutrition. 2015 Nov-Dec;31(11-12):1362-7. doi: 10.1016/j.nut.2015.05.025. Epub 2015 Jul 6.
PubMed 26429656Bouteloup C, Desport JC, Clavelou P, Guy N, Derumeaux-Burel H, Ferrier A, Couratier P. Hypermetabolism in ALS patients: an early and persistent phenomenon. J Neurol. 2009 Aug;256(8):1236-42. doi: 10.1007/s00415-009-5100-z. Epub 2009 Mar 22.
PubMed 19306035
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approach to Improving QoL in ALS
- ClinicalTrials.gov ID
- NCT03659422
- Acronym / sponsor ID
- 201802746
- Conditions
- Diet Modification, Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Collaborators
- Muscular Dystrophy Association
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Other: Modified Paleolithic dietModified 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Paleolithic dietThe 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. | Other | Intervention Arm |
Primary outcome
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
3 secondary outcomes
change in motor function over 12 weeks
Time frame: 12 weeks
change in breathing function over 12 weeks
Time frame: 12 weeks
Change in fatigue level
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Background: PubMed 9747926Milonas I. Amyotrophic lateral sclerosis: an introduction. J Neurol. 1998 Aug;245 Suppl 2:S1-3. doi: 10.1007/s004150050640.
- Background: PubMed 27637961Talbott EO, Malek AM, Lacomis D. The epidemiology of amyotrophic lateral sclerosis. Handb Clin Neurol. 2016;138:225-38. doi: 10.1016/B978-0-12-802973-2.00013-6.
- Background: PubMed 27377857Wang MD, Little J, Gomes J, Cashman NR, Krewski D. Identification of risk factors associated with onset and progression of amyotrophic lateral sclerosis using systematic review and meta-analysis. Neurotoxicology. 2017 Jul;61:101-130. doi: 10.1016/j.neuro.2016.06.015. Epub 2016 Jul 1.
- Background: PubMed 19209004Okamoto K, Kihira T, Kobashi G, Washio M, Sasaki S, Yokoyama T, Miyake Y, Sakamoto N, Inaba Y, Nagai M. Fruit and vegetable intake and risk of amyotrophic lateral sclerosis in Japan. Neuroepidemiology. 2009;32(4):251-6. doi: 10.1159/000201563. Epub 2009 Feb 11.
- Background: PubMed 23710627Jin Y, Oh K, Oh SI, Baek H, Kim SH, Park Y. Dietary intake of fruits and beta-carotene is negatively associated with amyotrophic lateral sclerosis risk in Koreans: a case-control study. Nutr Neurosci. 2014 Apr;17(3):104-8. doi: 10.1179/1476830513Y.0000000071. Epub 2013 Nov 26.
- Background: PubMed 25023276Fitzgerald KC, O'Reilly EJ, Falcone GJ, McCullough ML, Park Y, Kolonel LN, Ascherio A. Dietary omega-3 polyunsaturated fatty acid intake and risk for amyotrophic lateral sclerosis. JAMA Neurol. 2014 Sep;71(9):1102-10. doi: 10.1001/jamaneurol.2014.1214.
- Background: PubMed 7807136Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1994 Jul;124 Suppl:14-9. doi: 10.1016/0022-510x(94)90171-6.
- Background: PubMed 8229065Appel SH, Smith RG, Engelhardt JI, Stefani E. Evidence for autoimmunity in amyotrophic lateral sclerosis. J Neurol Sci. 1993 Sep;118(2):169-74. doi: 10.1016/0022-510x(93)90106-9.
- Background: PubMed 19910450Brown KJ, Jewells V, Herfarth H, Castillo M. White matter lesions suggestive of amyotrophic lateral sclerosis attributed to celiac disease. AJNR Am J Neuroradiol. 2010 May;31(5):880-1. doi: 10.3174/ajnr.A1826. Epub 2009 Nov 12.
- Background: PubMed 25867286Gadoth A, Nefussy B, Bleiberg M, Klein T, Artman I, Drory VE. Transglutaminase 6 Antibodies in the Serum of Patients With Amyotrophic Lateral Sclerosis. JAMA Neurol. 2015 Jun;72(6):676-81. doi: 10.1001/jamaneurol.2015.48.
- Background: PubMed 15200286Rao TV, Tharakan JK, Jacob PC. Systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. Clin Neuropathol. 2004 May-Jun;23(3):99-101.
- Background: PubMed 11908583Maldonado ME, Williams RC Jr, Adair JC, Hart BL, Gregg L, Sibbitt WL Jr. Neuropsychiatric systemic lupus erythematosus presenting as amyotrophic lateral sclerosis. J Rheumatol. 2002 Mar;29(3):633-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Wahls, MD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Modified Paleolithic diet in people with Diet Modification and Amyotrophic Lateral Sclerosis, run by Terry L. Wahls.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total body weight from baseline over 12 weeks. (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659422, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.