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| Name | Class |
|---|---|
| National Multiple Sclerosis Society | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swank Diet | Experimental | Individuals randomized to this arm will follow a low saturated fat diet starting at week 12. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant walk speed | 6 Minute Walk Test | 12-24 weeks |
| Change in participant walk speed | 6 Minute Walk Test | 12-36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terry L Wahls, MD, MBA | University of Iowa | Principal Investigator |
| Linda Snetselaar, PhD, RD, | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30728736 | Background | 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. | |
| 24476345 | Background |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
|
| Change in gait (walk) | 25 foot Walk Test | 12-24 weeks |
| Change in gait (walk) | 25 foot Walk Test | 12-36 weeks |
| Change in fine motor function | Pegboard test | 12-24 weeks |
| Change in fine motor function | Pegboard test | 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. | 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. | 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. | 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. | 12-36 weeks |
| Change in steps per day | Measured by accelerometer | 12-24 weeks |
| Change in steps per day | Measured by accelerometer | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | 12-36 weeks |
| 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. |
| 14771073 | 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. |
| 13836031 | Background | SWANK RL. Treatment of multiple sclerosis with a low-fat diet. J Am Diet Assoc. 1960 Apr;36:322-5. No abstract available. |
| 12996138 | 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. |
| 14375427 | 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. |
| 13373189 | 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. |
| 5471652 | 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. |
| 1804476 | Background | Swank RL. Multiple sclerosis: fat-oil relationship. Nutrition. 1991 Sep-Oct;7(5):368-76. |
| 13774215 | 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. |
| 1973220 | 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. |
| 12591551 | 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. |
| 12714108 | 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. |
| 37148578 | Result | 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. |
| 37916030 | 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. |
| 36742040 | 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. |
| 34377527 | 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. |
| 29866196 | Derived | 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |