Multiple SclerosisNCT01915433
Wahls Paleo Diet and Progressive Multiple Sclerosis
A study testing Wahls Paleo Plus and Wahls Diet in people with Multiple Sclerosis, run by Terry L. Wahls at 2 sites in United States.
Trial summary
Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Wahls Paleo Plus and Wahls Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Nov 2016
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Secondary or Primary Progressive MS, relapsing progressive MS, relapsing- remitting MS
- Generally able to walk 25 feet in less than 60 seconds;
- significant fatigue as documented by a fatigue severity scale score of 4 or more OR a modified fatigue impact scale score of 38 or higher.
- age between 30 and including 65 at entry into the RUN IN study,
- non smoker,
- willingness to be randomized
Show all 9Show fewer
- Mild gait disability as shown by an EDSS score of 4.5 or higher
- Confirmed MS diagnosis using McDonald criteria
- Eating standard American diet.
Who cannot join
- change in medication in the prior 90 days, taking anti-platelet or anticoagulant therapy therapy, or having a major psychiatric disorder making compliance difficult,
- SELF REPORTED history of current diagnosis of diabetes, or active liver, kidney or clinically significant heart disease,
- unable to record daily weight at home,
- eating a vegetarian diet or chronic diarrhea, have already adopted a Paleo Diet (as defined by a complete elimination of grain, dairy, and legumes)
- unable to cope with 30% in grocery bill,
- Alanine aminotransferase value > 2X normal, or elevated creatinine value, (main study only)
Show all 12Show fewer
- incompetence.
- Too low or too high BMI.
- Inability to follow study diet, which requires shopping carefully and food preparation, by either the study subject or with the help of an adult companion to do the shopping and food preparation.
- aversion to coconut milk
- Main Study Inclusion Criteria
- 1) Successful completion of RUN IN Study - which means, the subject completed the various quest. and survey documents that are part of the RUN-IN study, completed the food diary for each day they participated in the RUN-IN, the subject is eating the standard American Diet as documented by the daily food logs and the 24 hour dietary recalls.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Univeristy of Iowa
Iowa City, Iowa, 52240
Univeristy of Iowa
Iowa City, Iowa, 52246
About this study
Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in biomarkers than the usual care group experiences at 12 weeks. The usual care group will be given instruction in following both the wahls paleo plus and the wahls diet plans and how to utilize the daily food logs at the end of study visit. The usual care group will receive one nutrition coaching call to assist with implementation of the study diet.
Read the detailed description
Specific Aim 1. To assess changes in fatigue severity (primary outcome measure) and quality of life, motor, cognitive and emotional functions (secondary measures) the intervention groups (wahls paleo plus and wahls diet group)to usual care.
Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more improvements in quality of life and fatigue between baseline and 12 weeks than usual care group.
Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of life and fatigue than the wahls diet group.
Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the subject progresses through the study interventions.
Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable changes in blood biomarkers obtained at baseline and week 12 than the usual care group.
Hypothesis 2b: The wahls paleo plus group will demonstrate more favorable changes in blood biomarkers and quality of life than the wahls diet group experiences obtained at baseline and week 12.
Hypothesis 2c: The wahls paleo plus and the wahls diet group will demonstrate more favorable changes in measures of endothelial function between baseline and week 12 than will be observed in the usual care group.
Hypothesis 2d: The wahls paleo plus will demonstrate more favorable changes in measures of endothelial function between baseline and week 12 than the wahls diet group.
- Conditions
- Multiple Sclerosis
- Being tested
- Wahls Paleo Plus, Wahls Diet
- Keywords
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapsing progressive multiple sclerosis, relapsing remitting multiple sclerosis, Fatigue, Quality of life, Paleo, Nutrition, Ketogenic
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wahls Paleo PlusOther
Also called Wahls Paleo Plus (ketogenic diet)
The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low in carbohydrate and high in fat but still ensure consumption of the specific micronutrients important to optimal brain function. This diet is designed to induce a low level nutritional ketosis.
Wahls DietOther
Also called Wahls Diet (modified paleolithic diet)
The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low glycemic diet and also ensure consumption of the specific micronutrients important to optimal brain function.
| Study group | Role | What they receive |
|---|---|---|
| Wahls Paleo Plus | Experimental | Wahls Paleo Plus diet (ketogenic diet) Receives: Other: Wahls Paleo Plus |
| Wahls Diet | Experimental | Wahls Diet (modified paleolithic diet) Receives: Other: Wahls Diet |
| Usual Care | No intervention | Control - usual care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Fatigue
Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
Measured: Baseline, weeks, 4,8 and 12
Secondary outcomes (21)
Biomarkers
Biomarkers include weight, Body Mass Index,and blood biomarkers of renal and liver function, vitamin levels (A,C,K,D, B vitamins), homocysteine, h.s. c- reactive protein (CRP)
Measured: Baseline and 12 weeks
Biomarkers - glucose and ketones
GLucose, insulin, ketones, hemoglobin a1c to assess insulin sensitivity. Full intervention at baseline, and weeks 4,8,12 Minimal intervention at baseline and week 12.
Measured: Baseline and at 4, 8, 12 weeks
24 hr food recalls.
The 24 hr recalls will be collected at baseline in in the last 4 weeks of study. This will include nutrient analyses as well.
Measured: Baseline and 12 weeks
Daily Food logs
This is a record of daily food and beverage consumption. The two intervention groups will keep the record daily. The usual care group will keep the a food record the initial two weeks and for two weeks between weeks 10 and 12.
Measured: Baseline through end of study (12 weeks)
MS functional composite score.
This a composite of tests involving tests of walking, hand coordination and mental addition.
Measured: Baseline and end of study (12 weeks)
6 minute walk test
Subject will walk 6 minutes. They may rest as needed during the 6 minute time period. The total length of time that is walked will be recorded.
Measured: Baseline and week 12
Medical symptoms quest. (MSQ)
Scored review of systems questionaire
Measured: Baseline, weekly through week 12
Life spaces score
Questions about the locations subjects has been in the prior time period of interest.
Measured: Baseline and week 12
Medication audit
List of currently used medications, vitamins, supplements and over the counter medications.
Measured: Baseline
Physical examination
Summary of physical findings from physical examination.
Measured: baseline and 12 weeks
Health questions
A list of questions to identify common medical comorbid conditions and their severity if present.
Measured: baseline
MS Quality of Life (MSQoli 54)
MS Qoli 54 is a series of questions about physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
Measured: Baseline, week 12
MS Quality of life inventory (MSQLI)
MSQLI is a series of questions asking about daily life. Includes physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life.
Measured: Baseline and week 12
Demographic data
Questions about demographic attributes such as race, education, handedness.
Measured: Baseline and week 12
Functional Medicine assessment summary
A series of questions about a number of environmental risk factors for development of neurological and medical symptoms. Completed prior to orientation to study intervention diet after randomization (intervention groups) or at 12 weeks for usual care group.
Measured: Baseline or 12 weeks
Veteran Specific Activity Quest.
Series of questions about the tasks of daily life to identify how much activity the individual can safely do.
Measured: Baseline and 12 weeks.
MS Function Scale
A series of questions about the tasks of daily life.
Measured: baseline and week 12
Satiety scale
A series of questions about the sense of satiety or sense of fullness.
Measured: Baseline and weeks 10 and 11
Harvard Food Frequency Quest.
A series of questions about the frequency of a variety of foodstuffs to estimate nutrient intake.
Measured: Baseline
Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation
Brachial artery FMD and endothelium-independent dilation will be determined non-invasively using high-resolution ultrasonography.
Measured: Baseline and week 12
Expanded disability status score
Assessment of disability status
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915433
- Sponsor's protocol ID
- 201302829
- Status last verified
- Jun 2018
- First submitted
- 25 Jul 2013
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.
PubMed 21138391Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601.
PubMed 19918474Wahls TL. The seventy percent solution. J Gen Intern Med. 2011 Oct;26(10):1215-6. doi: 10.1007/s11606-010-1631-3. No abstract available.
PubMed 21253878Riccio P. The molecular basis of nutritional intervention in multiple sclerosis: a narrative review. Complement Ther Med. 2011 Aug;19(4):228-37. doi: 10.1016/j.ctim.2011.06.006. Epub 2011 Jul 27.
PubMed 21827937Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 2 : macronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):386-99.
PubMed 17066210Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 1: micronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):377-85.
PubMed 17066209Bowman GL, Silbert LC, Howieson D, Dodge HH, Traber MG, Frei B, Kaye JA, Shannon J, Quinn JF. Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging. Neurology. 2012 Jan 24;78(4):241-9. doi: 10.1212/WNL.0b013e3182436598. Epub 2011 Dec 28.
PubMed 22205763Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.
PubMed 19209185Stafstrom CE, Rho JM. The ketogenic diet as a treatment paradigm for diverse neurological disorders. Front Pharmacol. 2012 Apr 9;3:59. doi: 10.3389/fphar.2012.00059. eCollection 2012.
PubMed 22509165
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wahls Paleo Diet and Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01915433
- Acronym / sponsor ID
- 201302829
- Conditions
- Multiple Sclerosis
- Keywords
- Secondary Progressive Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Relapsing progressive multiple sclerosis, relapsing remitting multiple sclerosis, Fatigue, Quality of life, Paleo, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Aug 2013 (estimated)
- 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.
Based on favorable preliminary data from ongoing studies testing the safety and tolerability of a nutrition, exercise and neuromuscular electrical stimulation funded by Direct MS, the investigators are proposing a pilot study focused on the Wahls Paleo plus Diet and Wahls Diet intervention to usual care. The intent is to measure the effect size of a Wahls Paleo plus Diet and the effect size of the Wahls Diet in reducing fatigue and improving quality of life scores as measured by fatigue severity scale score and MS quality of life 54 physical and mental scores and various subscale scores. Inclusion criteria is the presence of fatigue and the diagnosis secondary and primary progressive MS, progressive relapsing MS or relapsing-remitting MS with an expanded disability status scale score (EDSS) score of 4.5 or greater but otherwise stable medically. The Wahls Paleo plus (ketogenic diet) and the Wahls diet (modified paleolithic diet) groups will be instructed in completing a daily food log and receive coaching from registered dieticians who are expert in motivational interviewing. The control group will receive usual care. Biomarkers of nutrient levels (e.g. vitamin) and inflammation, blood sugar and insulin levels will be monitored. Additional blood will be frozen for future analysis. Nutrient (e.g. vitamin and antioxidant) intake will be assessed using food frequency questionnaires and 24 hr diet recalls. Test of endothelial function will be done at baseline and 12 weeks. Outcome measures will be change in quality of life and fatigue, endothelial function and blood biomarkers between enrollment and end of study at 12 weeks. The hypotheses are that the diet intervention groups will experience reduced fatigue and improved quality of life and improved biomarkers 1) between zero and 12 weeks and that the wahls paleo plus (ketogenic diet) and the wahls diet (modified paleolithic diet) groups will experience more improvements in quality of life and reduced fatigue and in biomarkers than the usual care group experiences at 12 weeks. The usual care group will be given instruction in following both the wahls paleo plus and the wahls diet plans and how to utilize the daily food logs at the end of study visit. The usual care group will receive one nutrition coaching call to assist with implementation of the study diet.
Detailed description
Specific Aim 1. To assess changes in fatigue severity (primary outcome measure) and quality of life, motor, cognitive and emotional functions (secondary measures) the intervention groups (wahls paleo plus and wahls diet group)to usual care.
Hypothesis 1a: The Wahls Paleo plus group and the wahls diet group will both demonstrate more improvements in quality of life and fatigue between baseline and 12 weeks than usual care group.
Hypothesis 1b. The wahls paleo plus group will demonstrate more improvement in quality of life and fatigue than the wahls diet group.
Specific Aim 2. To assess changes in the blood biomarkers and endothelial function as the subject progresses through the study interventions.
Hypothesis 2a: The wahls paleo plus and the wahls diet group will demonstrate more favorable changes in blood biomarkers obtained at baseline and week 12 than the usual care group.
Hypothesis 2b: The wahls paleo plus group will demonstrate more favorable changes in blood biomarkers and quality of life than the wahls diet group experiences obtained at baseline and week 12.
Hypothesis 2c: The wahls paleo plus and the wahls diet group will demonstrate more favorable changes in measures of endothelial function between baseline and week 12 than will be observed in the usual care group.
Hypothesis 2d: The wahls paleo plus will demonstrate more favorable changes in measures of endothelial function between baseline and week 12 than the wahls diet group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wahls Paleo Plus | Experimental | Other: Wahls Paleo PlusWahls Paleo Plus diet (ketogenic diet) |
| Wahls Diet | Experimental | Other: Wahls DietWahls Diet (modified paleolithic diet) |
| Usual Care | No intervention | –Control - usual care only. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Secondary or Primary Progressive MS, relapsing progressive MS, relapsing- remitting MS
- Generally able to walk 25 feet in less than 60 seconds;
- significant fatigue as documented by a fatigue severity scale score of 4 or more OR a modified fatigue impact scale score of 38 or higher.
- age between 30 and including 65 at entry into the RUN IN study,
- non smoker,
Key exclusion criteria (12 listed)
- change in medication in the prior 90 days, taking anti-platelet or anticoagulant therapy therapy, or having a major psychiatric disorder making compliance difficult,
- SELF REPORTED history of current diagnosis of diabetes, or active liver, kidney or clinically significant heart disease,
- unable to record daily weight at home,
- eating a vegetarian diet or chronic diarrhea, have already adopted a Paleo Diet (as defined by a complete elimination of grain, dairy, and legumes)
- unable to cope with 30% in grocery bill,
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 |
|---|---|---|
| Wahls Paleo PlusAlso: Wahls Paleo Plus (ketogenic diet)The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low in carbohydrate and high in fat but still ensure consumption of the specific micronutrients important to optimal brain function. This diet is designed to induce a low level nutritional ketosis. | Other | Wahls Paleo Plus |
| Wahls DietAlso: Wahls Diet (modified paleolithic diet)The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low glycemic diet and also ensure consumption of the specific micronutrients important to optimal brain function. | Other | Wahls Diet |
Primary outcome
Perceived Fatigue
Time frame: Baseline, weeks, 4,8 and 12
Fatigue as measured by the fatigue severity scale and the modified fatigue impact scale
21 secondary outcomes
Biomarkers
Time frame: Baseline and 12 weeks
Biomarkers - glucose and ketones
Time frame: Baseline and at 4, 8, 12 weeks
24 hr food recalls.
Time frame: Baseline and 12 weeks
Daily Food logs
Time frame: Baseline through end of study (12 weeks)
MS functional composite score.
Time frame: Baseline and end of study (12 weeks)
6 minute walk test
Time frame: Baseline and week 12
Medical symptoms quest. (MSQ)
Time frame: Baseline, weekly through week 12
Life spaces score
Time frame: Baseline and week 12
Medication audit
Time frame: Baseline
Physical examination
Time frame: baseline and 12 weeks
Health questions
Time frame: baseline
MS Quality of Life (MSQoli 54)
Time frame: Baseline, week 12
MS Quality of life inventory (MSQLI)
Time frame: Baseline and week 12
Demographic data
Time frame: Baseline and week 12
Functional Medicine assessment summary
Time frame: Baseline or 12 weeks
Veteran Specific Activity Quest.
Time frame: Baseline and 12 weeks.
MS Function Scale
Time frame: baseline and week 12
Satiety scale
Time frame: Baseline and weeks 10 and 11
Harvard Food Frequency Quest.
Time frame: Baseline
Brachial artery dilation (FMD)and endothelium-dependent dilation, EDD) and endothelium-independent dilation
Time frame: Baseline and week 12
Expanded disability status score
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 21138391Wahls TL, Reese D, Kaplan D, Darling WG. Rehabilitation with neuromuscular electrical stimulation leads to functional gains in ambulation in patients with secondary progressive and primary progressive multiple sclerosis: a case series report. J Altern Complement Med. 2010 Dec;16(12):1343-9. doi: 10.1089/acm.2010.0080.
- Background: PubMed 19918474Reese D, Shivapour ET, Wahls TL, Dudley-Javoroski SD, Shields R. Neuromuscular electrical stimulation and dietary interventions to reduce oxidative stress in a secondary progressive multiple sclerosis patient leads to marked gains in function: a case report. Cases J. 2009 Aug 10;2:7601. doi: 10.4076/1757-1626-2-7601.
- Background: PubMed 21253878Wahls TL. The seventy percent solution. J Gen Intern Med. 2011 Oct;26(10):1215-6. doi: 10.1007/s11606-010-1631-3. No abstract available.
- Background: PubMed 21827937Riccio P. The molecular basis of nutritional intervention in multiple sclerosis: a narrative review. Complement Ther Med. 2011 Aug;19(4):228-37. doi: 10.1016/j.ctim.2011.06.006. Epub 2011 Jul 27.
- Background: PubMed 17066210Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 2 : macronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):386-99.
- Background: PubMed 17066209Bourre JM. Effects of nutrients (in food) on the structure and function of the nervous system: update on dietary requirements for brain. Part 1: micronutrients. J Nutr Health Aging. 2006 Sep-Oct;10(5):377-85.
- Background: PubMed 22205763Bowman GL, Silbert LC, Howieson D, Dodge HH, Traber MG, Frei B, Kaye JA, Shannon J, Quinn JF. Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging. Neurology. 2012 Jan 24;78(4):241-9. doi: 10.1212/WNL.0b013e3182436598. Epub 2011 Dec 28.
- Background: PubMed 19209185Frassetto LA, Schloetter M, Mietus-Synder M, Morris RC Jr, Sebastian A. Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet. Eur J Clin Nutr. 2009 Aug;63(8):947-55. doi: 10.1038/ejcn.2009.4. Epub 2009 Feb 11.
- Background: PubMed 22509165Stafstrom CE, Rho JM. The ketogenic diet as a treatment paradigm for diverse neurological disorders. Front Pharmacol. 2012 Apr 9;3:59. doi: 10.3389/fphar.2012.00059. eCollection 2012.
- 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 study director
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wahls Paleo Plus and Wahls Diet in people with Multiple Sclerosis, run by Terry L. Wahls at 2 sites 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 9 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Fatigue (time frame: Baseline, weeks, 4,8 and 12). 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 NCT01915433, which also lists 9 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 26 Jun 2018.