Approcci dietetici per il trattamento della fatica correlata alla sclerosi multipla Studio (Waves)
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Iowa
-
Iowa City, Iowa, Stati Uniti, 52242
- University of Iowa Hospitals and Clinics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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
- Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand)
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Swank Diet
Individuals randomized to this arm will follow a low saturated fat diet starting at week 12. |
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. |
|
Sperimentale: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in participant perceived fatigue severity
Lasso di tempo: 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) |
12-24 weeks
|
|
Change in participant perceived fatigue severity
Lasso di tempo: 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) |
12-36 weeks
|
|
Change in the impact of fatigue on daily life
Lasso di tempo: 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. |
12-24 weeks
|
|
Change in the impact of fatigue on daily life
Lasso di tempo: 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. |
12-36 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in participant walk speed
Lasso di tempo: 12-24 weeks
|
6 Minute Walk Test |
12-24 weeks
|
|
Change in participant walk speed
Lasso di tempo: 12-36 weeks
|
6 Minute Walk Test |
12-36 weeks
|
|
Change in gait (walk)
Lasso di tempo: 12-24 weeks
|
25 foot Walk Test |
12-24 weeks
|
|
Change in gait (walk)
Lasso di tempo: 12-36 weeks
|
25 foot Walk Test |
12-36 weeks
|
|
Change in fine motor function
Lasso di tempo: 12-24 weeks
|
Pegboard test |
12-24 weeks
|
|
Change in fine motor function
Lasso di tempo: 12-36 weeks
|
Pegboard test |
12-36 weeks
|
|
Change in nutrient intake based on the recommended daily allowance (RDA)
Lasso di tempo: 12-24 weeks
|
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)
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
Measured by accelerometer |
12-24 weeks
|
|
Change in steps per day
Lasso di tempo: 12-36 weeks
|
Measured by accelerometer |
12-36 weeks
|
|
Change in participant Quality of Life (QoL) - General Health
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
Lasso di tempo: 12-24 weeks
|
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
Lasso di tempo: 12-36 weeks
|
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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Terry L Wahls, MD, MBA, University of Iowa
- Investigatore principale: Linda Snetselaar, PhD, RD,, University of Iowa
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie autoimmuni demielinizzanti, SNC
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Sclerosi multipla
- Fatica
- Sclerosi multipla, recidivante-remittente
Altri numeri di identificazione dello studio
- 201604705
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Scientists may request data for a PROSPERO registered meta-analysis that has been published in a peer reviewed journal.
Periodo di condivisione IPD
One year after publication of data.
Criteri di accesso alla condivisione IPD
Scientists who have a PROSPERO registered meta-analysis with a protocol that has been published in a peer reviewed journal may request data for that meta-analysis. The scientist will use their academic email to reach out to the PI with the protocol manuscript describing the data that is requested, their address, phone number and contact details. Upon review of the documents, and the request, the PI will determine if the request meets guidelines. If the request is deemed appropriate the PI will initiate an outgoing material data use agreement with the Division of Sponsored Programs at the University of Iowa who will contact the requesting scientists to sign the contract.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .