Multiple SclerosisWavesNCT02914964
Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
A study testing Swank Diet and Wahls Elimination Diet in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Terry L. Wahls at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Swank Diet and Wahls Elimination Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 26 Feb 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
- Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
- Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
- Between the ages of 18 and 70
- Body Mass Index greater than or equal to 19
- Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines
Show all 16Show fewer
- Willingness to keep detailed food records
- Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour,
- Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day
- Must not be pregnant or planning to become pregnant in the next year
- Willing to eat meat (eg, chicken, turkey, fish)
- Willingness to follow either the Wahls Elimination diet or the Swank diet
- Individuals who have had gastric bypass surgery have obtained a signed statement from their physician indicating they are weight stable and a suitable candidate for this study
- Normal or mild cognitive impairment as measured by the Short Portable Mental Status Questionnaire
- Willing to have blood drawn
- Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand)
Who cannot join
- Taking insulin or Coumadin
- Relapse within past 12 weeks
- Treatment for a cancer (other than skin cancer) currently or in the prior 12 months
- Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety
- Body Mass Index less than 19
- Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire
Show all 12Show fewer
- Inability to shop for and prepare home cooked meals by the subject or a companion
- Unwillingness to eat meat
- Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments
- Inability to keep food records with sufficient detail to asses dietary intake or complete study questionnaires
- Unwilling to have blood drawn
- Pregnant or planning to become pregnant in the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.
Read the detailed description
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks. Individuals will continue with their current treatments in addition to following the study diet.
The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City, Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed food records, motor and cognitive testing, physical activity assessment, questionnaires, and daily diet checklists while following the study diet. Some reimbursement available.
- Being tested
- Swank Diet, Wahls Elimination Diet
- Keywords
- Fatigue, Quality of Life, Diet
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swank DietBehavioural
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling to study participants to assist them in following the Swank Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.
Wahls Elimination DietBehavioural
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling using to study participants to assist them in following the Wahls Elimination Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Swank Diet | Experimental | Individuals randomized to this arm will follow a low saturated fat diet starting at week 12. Receives: Behavioral: Swank Diet |
| Wahls Elimination Diet | Experimental | Individuals randomized to this arm will follow a modified paleolithic diet that eliminates all grains, dairy, eggs, legumes, and nightshade vegetables/spices starting at week 12. Receives: Behavioral: Wahls Elimination Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant perceived fatigue severity
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
Measured: 12-24 weeks
Change in participant perceived fatigue severity
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
Measured: 12-36 weeks
Change in the impact of fatigue on daily life
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
Measured: 12-24 weeks
Change in the impact of fatigue on daily life
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
Measured: 12-36 weeks
Secondary outcomes (22)
Change in participant walk speed
6 Minute Walk Test
Measured: 12-24 weeks
Change in participant walk speed
6 Minute Walk Test
Measured: 12-36 weeks
Change in gait (walk)
25 foot Walk Test
Measured: 12-24 weeks
Change in gait (walk)
25 foot Walk Test
Measured: 12-36 weeks
Change in fine motor function
Pegboard test
Measured: 12-24 weeks
Change in fine motor function
Pegboard test
Measured: 12-36 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.
Measured: 12-24 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.
Measured: 12-36 weeks
Change in cognitive function
Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.
Measured: 12-24 weeks
Change in cognitive function
Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.
Measured: 12-36 weeks
Change in steps per day
Measured by accelerometer
Measured: 12-24 weeks
Change in steps per day
Measured by accelerometer
Measured: 12-36 weeks
Change in participant Quality of Life (QoL) - General Health
Multiple Sclerosis 54 Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.
Measured: 12-24 weeks
Change in participant Quality of Life (QoL) - General Health
Multiple Sclerosis Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.
Measured: 12-36 weeks
Change in participant Quality of Life (QoL) - Mental Health
Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.
Measured: 12-24 weeks
Change in participant Quality of Life (QoL) - Mental Health
Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.
Measured: 12-36 weeks
Change in total sleep time
Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study
Measured: 12-24 weeks
Change in total sleep time
Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study
Measured: 12-36 weeks
Change in perceived anxiety
Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
Measured: 12-24 weeks
Change in perceived anxiety
Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
Measured: 12-36 weeks
Change in perceived depression
Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
Measured: 12-24 weeks
Change in perceived depression
Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
Measured: 12-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion26 Jan 2020
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terry L. Wahls
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Sponsor-investigator, Terry L. Wahls, University of Iowa
- Investigators
- Terry L Wahls, MD, MBA, Principal investigator, University of IowaLinda Snetselaar, PhD, RD,, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914964
- Sponsor's protocol ID
- 201604705
- Acronym
- Waves
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2016
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scientists may request data for a PROSPERO registered meta-analysis that has been published in a peer reviewed journal.
Publications
Bisht B, Darling WG, Shivapour ET, Lutgendorf SK, Snetselaar LG, Chenard CA, Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27.
PubMed 30728736Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.
PubMed 24476345SWANK RL. Multiple sclerosis; a correlation of its incidence with dietary fat. Am J Med Sci. 1950 Oct;220(4):421-30. No abstract available.
PubMed 14771073SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available.
PubMed 13836031SWANK RL. Treatment of multiple sclerosis with low-fat diet. AMA Arch Neurol Psychiatry. 1953 Jan;69(1):91-103. doi: 10.1001/archneurpsyc.1953.02320250097011. No abstract available.
PubMed 12996138SWANK RL. Treatment of multiple sclerosis with low-fat diet; results of five and one-half years' experience. AMA Arch Neurol Psychiatry. 1955 Jun;73(6):631-44. doi: 10.1001/archneurpsyc.1955.02330120035004. No abstract available.
PubMed 14375427SWANK RL. Treatment of multiple sclerosis with low-fat diet: result of seven years' experience. Ann Intern Med. 1956 Nov;45(5):812-24. doi: 10.7326/0003-4819-45-5-812. No abstract available.
PubMed 13373189Swank RL. Multiple sclerosis: twenty years on low fat diet. Arch Neurol. 1970 Nov;23(5):460-74. doi: 10.1001/archneur.1970.00480290080009. No abstract available.
PubMed 5471652Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76.
PubMed 1804476SWANK RL, BOURDILLON RB. Multiple sclerosis: assessment of treatment with a modified low-fat diet. J Nerv Ment Dis. 1960 Dec;131:468-88. No abstract available.
PubMed 13774215Swank RL, Dugan BB. Effect of low saturated fat diet in early and late cases of multiple sclerosis. Lancet. 1990 Jul 7;336(8706):37-9. doi: 10.1016/0140-6736(90)91533-g.
PubMed 1973220Swank RL, Goodwin J. Review of MS patient survival on a Swank low saturated fat diet. Nutrition. 2003 Feb;19(2):161-2. doi: 10.1016/s0899-9007(02)00851-1. No abstract available.
PubMed 12591551Swank RL, Goodwin JW. How saturated fats may be a causative factor in multiple sclerosis and other diseases. Nutrition. 2003 May;19(5):478. doi: 10.1016/s0899-9007(02)01099-7. No abstract available.
PubMed 12714108Shemirani F, Titcomb TJ, Saxby SM, Eyck PT, Rubenstein LM, Hoth KF, Snetselaar LG, Wahls TL. Association of serum homocysteine, folate, and vitamin B12 and mood following the Swank and Wahls elimination dietary interventions in relapsing-remitting multiple sclerosis: Secondary analysis of the WAVES trial. Mult Scler Relat Disord. 2023 Jul;75:104743. doi: 10.1016/j.msard.2023.104743. Epub 2023 May 1.
PubMed 37148578Crippes LJ, Saxby SM, Shemirani F, Bisht B, Gill C, Rubenstein LM, Ten Eyck P, Carr LJ, Darling WG, Hoth KF, Kamholz J, Snetselaar LG, Titcomb TJ, Wahls TL. Diet-induced changes in functional disability are mediated by fatigue in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES randomized parallel-arm trial. Mult Scler J Exp Transl Clin. 2023 Oct 30;9(4):20552173231209147. doi: 10.1177/20552173231209147. eCollection 2023 Oct-Dec.
PubMed 37916030
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
- ClinicalTrials.gov ID
- NCT02914964
- Acronym / sponsor ID
- Waves / 201604705
- Keywords
- Fatigue, Quality of Life, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Terry L. WahlsUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Aug 2016 (actual)
- Primary completion
- 26 Jan 2020 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 26 Sep 2016 (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.
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.
Detailed description
The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks. Individuals will continue with their current treatments in addition to following the study diet.
The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City, Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed food records, motor and cognitive testing, physical activity assessment, questionnaires, and daily diet checklists while following the study diet. Some reimbursement available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Swank Diet | Experimental | Behavioral: Swank DietIndividuals randomized to this arm will follow a low saturated fat diet starting at week 12. |
| Wahls Elimination Diet | Experimental | Behavioral: Wahls Elimination DietIndividuals randomized to this arm will follow a modified paleolithic diet that eliminates all grains, dairy, eggs, legumes, and nightshade vegetables/spices starting at week 12. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
- Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
- Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
- Between the ages of 18 and 70
- Body Mass Index greater than or equal to 19
Key exclusion criteria (12 listed)
- Taking insulin or Coumadin
- Relapse within past 12 weeks
- Treatment for a cancer (other than skin cancer) currently or in the prior 12 months
- Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety
- Body Mass Index less than 19
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 |
|---|---|---|
| Swank DietA Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling to study participants to assist them in following the Swank Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention. | Behavioural | Swank Diet |
| Wahls Elimination DietA Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling using to study participants to assist them in following the Wahls Elimination Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention. | Behavioural | Wahls Elimination Diet |
Primary outcome
Change in participant perceived fatigue severity
Time frame: 12-24 weeks
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
Change in participant perceived fatigue severity
Time frame: 12-36 weeks
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
Change in the impact of fatigue on daily life
Time frame: 12-24 weeks
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
Change in the impact of fatigue on daily life
Time frame: 12-36 weeks
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
22 secondary outcomes
Change in participant walk speed
Time frame: 12-24 weeks
Change in participant walk speed
Time frame: 12-36 weeks
Change in gait (walk)
Time frame: 12-24 weeks
Change in gait (walk)
Time frame: 12-36 weeks
Change in fine motor function
Time frame: 12-24 weeks
Change in fine motor function
Time frame: 12-36 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Time frame: 12-24 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Time frame: 12-36 weeks
Change in cognitive function
Time frame: 12-24 weeks
Change in cognitive function
Time frame: 12-36 weeks
Change in steps per day
Time frame: 12-24 weeks
Change in steps per day
Time frame: 12-36 weeks
Change in participant Quality of Life (QoL) - General Health
Time frame: 12-24 weeks
Change in participant Quality of Life (QoL) - General Health
Time frame: 12-36 weeks
Change in participant Quality of Life (QoL) - Mental Health
Time frame: 12-24 weeks
Change in participant Quality of Life (QoL) - Mental Health
Time frame: 12-36 weeks
Change in total sleep time
Time frame: 12-24 weeks
Change in total sleep time
Time frame: 12-36 weeks
Change in perceived anxiety
Time frame: 12-24 weeks
Change in perceived anxiety
Time frame: 12-36 weeks
Change in perceived depression
Time frame: 12-24 weeks
Change in perceived depression
Time frame: 12-36 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 18 Sep 2026.
- Background: PubMed 30728736Bisht B, Darling WG, Shivapour ET, Lutgendorf SK, Snetselaar LG, Chenard CA, Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27.
- Background: PubMed 24476345Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.
- Background: PubMed 14771073SWANK RL. Multiple sclerosis; a correlation of its incidence with dietary fat. Am J Med Sci. 1950 Oct;220(4):421-30. No abstract available.
- Background: PubMed 13836031SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available.
- Background: PubMed 12996138SWANK RL. Treatment of multiple sclerosis with low-fat diet. AMA Arch Neurol Psychiatry. 1953 Jan;69(1):91-103. doi: 10.1001/archneurpsyc.1953.02320250097011. No abstract available.
- Background: PubMed 14375427SWANK RL. Treatment of multiple sclerosis with low-fat diet; results of five and one-half years' experience. AMA Arch Neurol Psychiatry. 1955 Jun;73(6):631-44. doi: 10.1001/archneurpsyc.1955.02330120035004. No abstract available.
- Background: PubMed 13373189SWANK RL. Treatment of multiple sclerosis with low-fat diet: result of seven years' experience. Ann Intern Med. 1956 Nov;45(5):812-24. doi: 10.7326/0003-4819-45-5-812. No abstract available.
- Background: PubMed 5471652Swank RL. Multiple sclerosis: twenty years on low fat diet. Arch Neurol. 1970 Nov;23(5):460-74. doi: 10.1001/archneur.1970.00480290080009. No abstract available.
- Background: PubMed 1804476Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76.
- Background: PubMed 13774215SWANK RL, BOURDILLON RB. Multiple sclerosis: assessment of treatment with a modified low-fat diet. J Nerv Ment Dis. 1960 Dec;131:468-88. No abstract available.
- Background: PubMed 1973220Swank RL, Dugan BB. Effect of low saturated fat diet in early and late cases of multiple sclerosis. Lancet. 1990 Jul 7;336(8706):37-9. doi: 10.1016/0140-6736(90)91533-g.
- Background: PubMed 12591551Swank RL, Goodwin J. Review of MS patient survival on a Swank low saturated fat diet. Nutrition. 2003 Feb;19(2):161-2. doi: 10.1016/s0899-9007(02)00851-1. No abstract available.
- Individual participant dataSharing planned: Yes. Scientists may request data for a PROSPERO registered meta-analysis that has been published in a peer reviewed journal.
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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, MBA principal investigator
University of Iowa
Linda Snetselaar, PhD, RD, 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 Swank Diet and Wahls Elimination Diet in people with Multiple Sclerosis and Multiple Sclerosis, Relapsing-Remitting, run by Terry L. Wahls 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 16 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 18 Sep 2026. 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?
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?
Change in participant perceived fatigue severity (time frame: 12-24 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 NCT02914964, which also lists 18 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 18 Sep 2026.