Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
NCT ID: NCT02914964
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2016-08-31
2025-02-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Swank Diet
Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.
Swank Diet
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 Diet
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.
Wahls Elimination Diet
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.
Interventions
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Swank Diet
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 Diet
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
Terry L. Wahls
OTHER
Responsible Party
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Terry L. Wahls
Clinical Professor
Principal Investigators
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Terry L Wahls, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Linda Snetselaar, PhD, RD,
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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References
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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.
Bisht 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.
SWANK RL. Multiple sclerosis; a correlation of its incidence with dietary fat. Am J Med Sci. 1950 Oct;220(4):421-30. No abstract available.
SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available.
SWANK 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.
SWANK 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.
SWANK 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.
Swank 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.
Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76.
SWANK 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.
Swank 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.
Swank 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.
Swank 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.
Shemirani 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.
Crippes 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.
Villa AT, Tu BH, Titcomb TJ, Saxby SM, Shemirani F, Ten Eyck P, Rubenstein LM, Snetselaar LG, Wahls TL. Association between improved metabolic risk factors and perceived fatigue during dietary intervention trial in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES trial. Front Neurol. 2023 Jan 19;13:1022728. doi: 10.3389/fneur.2022.1022728. eCollection 2022.
Wahls TL, Titcomb TJ, Bisht B, Eyck PT, Rubenstein LM, Carr LJ, Darling WG, Hoth KF, Kamholz J, Snetselaar LG. Impact of the Swank and Wahls elimination dietary interventions on fatigue and quality of life in relapsing-remitting multiple sclerosis: The WAVES randomized parallel-arm clinical trial. Mult Scler J Exp Transl Clin. 2021 Jul 31;7(3):20552173211035399. doi: 10.1177/20552173211035399. eCollection 2021 Jul-Sep.
Wahls T, Scott MO, Alshare Z, Rubenstein L, Darling W, Carr L, Smith K, Chenard CA, LaRocca N, Snetselaar L. Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial. Trials. 2018 Jun 4;19(1):309. doi: 10.1186/s13063-018-2680-x.
Other Identifiers
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201604705
Identifier Type: -
Identifier Source: org_study_id
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