Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

NCT02914964 | Completed DMC

• 1 other identifier: 201604705
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Keywords

Fatigue; Quality of Life; Diet

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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.

  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.

  12-36 weeks

Secondary Outcomes (22)

• Change in participant walk speed

  12-24 weeks

• Change in participant walk speed

  12-36 weeks

• Change in gait (walk)

  12-24 weeks

• Change in gait (walk)

  12-36 weeks

• Change in fine motor function

  12-24 weeks

Study Arms (2)

Swank Diet

EXPERIMENTAL

Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.

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.

Behavioral: Wahls Elimination Diet

Interventions

Swank Diet BEHAVIORAL

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.

Swank Diet

Wahls Elimination Diet BEHAVIORAL

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.

Wahls Elimination Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Terry L. Wahls: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (18)

• 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.

  PMID: 30728736 BACKGROUND

• 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.

  PMID: 24476345 BACKGROUND

• 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.

  PMID: 14771073 BACKGROUND

• SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available.

  PMID: 13836031 BACKGROUND

• 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.

  PMID: 12996138 BACKGROUND

• 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.

  PMID: 14375427 BACKGROUND

• 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.

  PMID: 13373189 BACKGROUND

• 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.

  PMID: 5471652 BACKGROUND

• Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76.

  PMID: 1804476 BACKGROUND

• 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.

  PMID: 13774215 BACKGROUND

• 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.

  PMID: 1973220 BACKGROUND

• 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.

  PMID: 12591551 BACKGROUND

• 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.

  PMID: 12714108 BACKGROUND

• 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.

  PMID: 37148578 RESULT

• 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.

  PMID: 37916030 RESULT

• 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.

  PMID: 36742040 RESULT

• 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.

  PMID: 34377527 RESULT

• 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.

  PMID: 29866196 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Terry L Wahls, MD, MBA

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Linda Snetselaar, PhD, RD,

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 26, 2016
• Study Start: August 1, 2016
• Primary Completion: January 26, 2020
• Study Completion: February 26, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)