Multiple Sclerosis, Relapsing-remittingNCT02687919
Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis
A study testing Modified Paleo diet in people with Multiple Sclerosis, Relapsing-remitting, run by Amanda Irish at 1 site in United States.
Trial summary
This is a research study. The investigators are inviting participants to participate in this research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of the following: liver disease, kidney disease… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- Modified Paleo diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Verified diagnosis of relapsing-remitting multiple sclerosis (RRMS) with no change in medications in the prior three months.
- Able to ambulate a minimum of 25 feet with/without use of an assistive device.
Who cannot join
- Under the age of 18 or over the age of 45 at the beginning of the study.
- Unstable MS, requiring a change in medication in the prior 3 months.
- Unwillingness to contact, or allow research to contact, neurologist for verification of RRMS diagnosis.
- Psychosis or other psychiatric disorder likely to impact ability to comply with study procedures.
- Change in prescriptions medication in the prior three months for a mental health problem such as depression or anxiety.
- Active malignancy undergoing treatment (not including non melanoma skin cancers).
Show all 12Show fewer
- Subjects with liver disease, kidney disease, diabetes, active heart disease, heart block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet use.
- Abnormal bleeding disorder.
- On any "diet" recommended to treat MS (ex: Best Bet, Swank, McDougall, MS Recovery diet, Wahls', other Paleolithic, gluten-free, vegetarian, and/or vegan
- Inability to maintain food log for for seven consecutive days during the run-in phase of the study.
- Not comfortable using a computer.
- Other failure to demonstrate compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study
This is a research study. The investigators are inviting participants to participate in this research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of the following: liver disease, kidney disease, diabetes, active heart disease, heart block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet use, psychosis or other psychiatric disorder likely to impact ability to comply with study procedures, any change in prescription medication for a mental health problem such as depression or anxiety in the last three months.
The purpose of this research study is to determine whether or not a modified Paleolithic diet results in any change in health in persons with RRMS compared to usual care. The investigators define usual care as the typical or usual physician recommendations for the treatment of RRMS.
Read more
The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5 million years duration that ended around 10,000 years ago with the development of agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables, fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.
To the investigators' knowledge, most neurologists prescribe medications that may reduce or prevent future disability, but few prescribe dietary modifications unless needed for other concomitant disease.
Read the detailed description
Initial visit/baseline measures for intervention and control groups (1-2 hrs): Subject Info and Demographics, Fatigue Severity Scale (FSS), Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) [Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT).
Complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24).
Two-week run-in for intervention and control groups: Return survey instruments: [Multiple Sclerosis Quality of Life-54 (MSQOL-54), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, and Food Diary]. Randomization; training for intervention and control groups (1-2 hrs). Training for the intervention group will involve orientation of subjects to the modified paleo diet and food logging; control group training will consist of study expectations (maintenance of normal diet) and food logging. Both will be conducted by a research team member, with subjects, on an individual basis.
Begin 3-month study: 1 short follow-up call per week, for first three weeks, then every other week thereafter asking intervention and control group subjects if they need assistance with study procedures and providing assistance when needed/possible and ensuring subjects are accurately maintaining daily food log/diary (5 mins; could be longer/shorter depending on subject needs). If a subject (intervention or control arm) is having difficulty filling out the Food Log/Food Diary, he/she will have the opportunity to meet with research team members at a location of the subject's choosing (to include web-conferencing) for supplemental instruction.
At 1 month and few days before returning for the final visit, complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24).
Final visit* for intervention and control groups (1-2 hrs): Multiple Sclerosis Quality of Life-54 (MSQOL-54), Fatigue Severity Scale (FSS), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, Food Log, Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) [Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT). *End of participation for intervention group or cross-over (from control to 3-month intervention) for interested control group subjects.
If regular in-person meetings are not possible (for two-week recall and/or supplemental instruction), a subject may choose to communicate with research staff via a web conferencing application (Google Hangout). The privacy policy may be found here: http://www.google.com/policies/privacy/ and will be provided to subjects upon request.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- Modified Paleo diet
- Keywords
- diet (gluten-free), diet therapy, quality of life
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Paleo dietOther
Also called Modified Paleolithic Diet
Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | Experimental | Consumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) Receives: Other: Modified Paleo diet |
| Usual Care | No intervention | Typical physician recommendations for MS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Severity Scale (FSS)-9 Score
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score.
A 9-item sel-report questionnaire related to how fatigue interferes with certain activities and rates its severity, items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score is 63. Higher the score indicates greater fatigue severity.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Change in Paced Auditory Serial Addition Test (PASAT) Score
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score.
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT (0-60) is the total number correct out of 60 possible answers.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Change in 6-minute Walk (6-MW) Distance
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW).
Timed 6-minute walk (6-MW): a submaximal measure of gait velocity and endurance over a distance (m) walked in 6 minutes.
Measured: End of Study, 3.5 months; Change from Baseline
Change in (25-FW) 25-ft Walk Time
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (d) physical fatigue as measured by the 25-ft walk (25-FW; (s).
Timed 25-Foot Walk (T25-FW): a quantitative test of maximal walking velocity, mobility, dynamic balance and leg function. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and as safely, as possible. The time is recorded from the first step across the line and ends when the patient crosses the same foot over the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Secondary outcomes (8)
Quality of Life (MSQOL-54)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by: Multiple Sclerosis Quality of Life-54 (MSQOL-54) Mental and Physical Health scores.
Multiple Sclerosis Quality of Life-54 (MSQOL-54): a multidimensional health-related quality of life survey that combines both generic and MS-specific items into a single instrument. Higher scores (0-100) indicate improved health.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamin B-1 Blood Serum Measures)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-1 (thiamine) blood serum measures.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamin B-9 Blood Serum Measures)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-9 (folate) blood serum measures.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamins B-12 and K Blood Serum Measures)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by blood serum measures: vitamin B-12 (cobalamin) and vitamin K.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Homocysteine Blood Serum Measures)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by homocysteine (HCY) blood serum measures.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (C-reactive Protein Blood Serum Measures)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by C-reactive protein (hs-CRP) blood serum measures.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (9-HPT)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the 9-Hole Peg Test (9-HPT).
9-Hole Peg Test: a brief, standardized, quantitative test of upper extremity function. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes (Rolyan 9-Hole Peg Test Kit - Model A8515). On a start command a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The score for the 9-HPT is an average of the two trials for each hand.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (VSAQ)
Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the Veterans Specific Activity Questionnaire (VSAQ).
Veterans Specific Activity Questionnaire (VSAQ): a self-reported survey instrument that serves as a strong predictor of both measured and predicted exercise capacity. Subjects identify a series of activities that they can complete on a typical day (scaled 1-11 for estimated metabolic equivalents (METs)), higher METs indicate increased exercise capacity.
Measured: End of Study, measured at 3.5 months; Change from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis, Relapsing-remittingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amanda Irish
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amanda Irish, University of Iowa
- Investigators
- Amanda K Irish, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687919
- Sponsor's protocol ID
- 201208703
- Status last verified
- Jul 2019
- First submitted
- 22 Jan 2016
- Last updated
- 12 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data from this study are complex and housed in different formats, but are available by contacting the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Evaluation of a Modified Paleolithic Dietary Intervention in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02687919
- Acronym / sponsor ID
- 201208703
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- diet (gluten-free), diet therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Amanda IrishUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study. The investigators are inviting participants to participate in this research study between the ages of 18-45, who have stable Relapsing-Remitting Multiple Sclerosis (RRMS), are able to walk 25 ft with/without an assistive device, and have none of the following: liver disease, kidney disease, diabetes, active heart disease, heart block or arrhythmias, bleeding disorders, concurrent diuretic use, anti-coagulation or anti-platelet use, psychosis or other psychiatric disorder likely to impact ability to comply with study procedures, any change in prescription medication for a mental health problem such as depression or anxiety in the last three months.
The purpose of this research study is to determine whether or not a modified Paleolithic diet results in any change in health in persons with RRMS compared to usual care. The investigators define usual care as the typical or usual physician recommendations for the treatment of RRMS.
The Paleolithic diet (or Paleo diet), also referred to as the caveman diet, Stone Age diet, and hunter-gatherer diet, is a modern nutritional plan based on the presumed ancient diet of wild plants and animals of ancestral humans during the Paleolithic era (a period of about 2.5 million years duration that ended around 10,000 years ago with the development of agriculture). The diet consists mainly of fish, grass-fed pasture raised meats, vegetables, fruit, fungi, roots, and nuts, and excludes grains, legumes, dairy products, salt, refined sugar, and processed oils.
To the investigators' knowledge, most neurologists prescribe medications that may reduce or prevent future disability, but few prescribe dietary modifications unless needed for other concomitant disease.
Detailed description
Initial visit/baseline measures for intervention and control groups (1-2 hrs): Subject Info and Demographics, Fatigue Severity Scale (FSS), Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) [Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT).
Complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24).
Two-week run-in for intervention and control groups: Return survey instruments: [Multiple Sclerosis Quality of Life-54 (MSQOL-54), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, and Food Diary]. Randomization; training for intervention and control groups (1-2 hrs). Training for the intervention group will involve orientation of subjects to the modified paleo diet and food logging; control group training will consist of study expectations (maintenance of normal diet) and food logging. Both will be conducted by a research team member, with subjects, on an individual basis.
Begin 3-month study: 1 short follow-up call per week, for first three weeks, then every other week thereafter asking intervention and control group subjects if they need assistance with study procedures and providing assistance when needed/possible and ensuring subjects are accurately maintaining daily food log/diary (5 mins; could be longer/shorter depending on subject needs). If a subject (intervention or control arm) is having difficulty filling out the Food Log/Food Diary, he/she will have the opportunity to meet with research team members at a location of the subject's choosing (to include web-conferencing) for supplemental instruction.
At 1 month and few days before returning for the final visit, complete at home/office/other: Automated Self-Administered 24-hour recall application (ASA24).
Final visit* for intervention and control groups (1-2 hrs): Multiple Sclerosis Quality of Life-54 (MSQOL-54), Fatigue Severity Scale (FSS), Veterans Specific Activity Questionnaire (VSAQ), Medication, Vitamin, and Supplement Log, Food Log, Blood draw (vitamin B-1 (thiamine), vitamin B-9 (folate), vitamin B-12 (cobalamin), vitamin K, homocysteine, C-reactive protein), MS Functional Composite (MSFC) [Timed 25-Foot Walk (T25-FW), 9-Hole Peg Test (9-HPT), Paced Auditory Serial Addition Test (PASAT)], 6-minute walk, and Paced Visual Serial Addition Test (PVSAT). *End of participation for intervention group or cross-over (from control to 3-month intervention) for interested control group subjects.
If regular in-person meetings are not possible (for two-week recall and/or supplemental instruction), a subject may choose to communicate with research staff via a web conferencing application (Google Hangout). The privacy policy may be found here: http://www.google.com/policies/privacy/ and will be provided to subjects upon request.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Paleo Diet Intervention (MPDI) | Experimental | Other: Modified Paleo dietConsumed a modified Paleo diet, described as nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) |
| Usual Care | No intervention | –Typical physician recommendations for MS. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Verified diagnosis of relapsing-remitting multiple sclerosis (RRMS) with no change in medications in the prior three months.
- Able to ambulate a minimum of 25 feet with/without use of an assistive device.
Key exclusion criteria (12 listed)
- Under the age of 18 or over the age of 45 at the beginning of the study.
- Unstable MS, requiring a change in medication in the prior 3 months.
- Unwillingness to contact, or allow research to contact, neurologist for verification of RRMS diagnosis.
- Psychosis or other psychiatric disorder likely to impact ability to comply with study procedures.
- Change in prescriptions medication in the prior three months for a mental health problem such as depression or anxiety.
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 Paleo dietAlso: Modified Paleolithic DietNine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.) | Other | Modified Paleo Diet Intervention (MPDI) |
Primary outcome
Change in Fatigue Severity Scale (FSS)-9 Score
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score. A 9-item sel-report questionnaire related to how fatigue interferes with certain activities and rates its severity, items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score is 63. Higher the score indicates greater fatigue severity.
Change in Paced Auditory Serial Addition Test (PASAT) Score
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score. The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT (0-60) is the total number correct out of 60 possible answers.
Change in 6-minute Walk (6-MW) Distance
Time frame: End of Study, 3.5 months; Change from Baseline
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW). Timed 6-minute walk (6-MW): a submaximal measure of gait velocity and endurance over a distance (m) walked in 6 minutes.
Change in (25-FW) 25-ft Walk Time
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (d) physical fatigue as measured by the 25-ft walk (25-FW; (s). Timed 25-Foot Walk (T25-FW): a quantitative test of maximal walking velocity, mobility, dynamic balance and leg function. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and as safely, as possible. The time is recorded from the first step across the line and ends when the patient crosses the same foot over the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
8 secondary outcomes
Quality of Life (MSQOL-54)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamin B-1 Blood Serum Measures)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamin B-9 Blood Serum Measures)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Vitamins B-12 and K Blood Serum Measures)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (Homocysteine Blood Serum Measures)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (C-reactive Protein Blood Serum Measures)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (9-HPT)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Quality of Life (VSAQ)
Time frame: End of Study, measured at 3.5 months; Change from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data from this study are complex and housed in different formats, but are available by contacting the corresponding author.
Related trials for Multiple Sclerosis, Relapsing-remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
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.
Amanda K Irish principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Paleo diet in people with Multiple Sclerosis, Relapsing-remitting, run by Amanda Irish at 1 site in United States.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Fatigue Severity Scale (FSS)-9 Score (time frame: End of Study, measured at 3.5 months; Change from Baseline). 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?
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 12 Aug 2019.