Efficacité du régime alimentaire sur la qualité de vie dans la sclérose en plaques (EDQ)
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Complément alimentaire: BodyBio Balance Oil
- Complément alimentaire: Kirunal Fish Oil
- Complément alimentaire: BodyBio PC
- Comportemental: Modified Paleolithic Elimination diet
- Comportemental: Time Restricted Olive Oil Based (TROO) Ketogenic Diet
- Comportemental: Usual diet with Dietary Guidelines for Americans Diet information
Description détaillée
In the United States, MS affects nearly 1 million people with a 2.8:1 female to male ratio and the highest incidence rates among whites and African Americans. The economic cost of managing MS is substantial. In the U.S., the total medical costs for patients with MS increased from $116 million in 2002 to $198 million in 2013. MS is a chronic, neuroinflammatory, and neurodegenerative disease-causing symptoms of pain, fatigue, and changes in vision, cognition, and movement that greatly reduce quality of life (QoL) and the ability to maintain employment.
The overarching goal of this project is to critically evaluate the efficacy of incorporating dietary guidance within multiple sclerosis (MS) care for improving long-term quality of life (QoL) compared to usual care. The primary objective of this study is to evaluate the effect of two dietary interventions (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination) on MS QoL compared to usual care control (Dietary Guidelines for America), and the secondary objectives and the long-term effects on, motor function, low-contrast vision sensitivity, fatigue, mood, and disease activity assessed by brain imaging.
The proposed study will consist of study participants attending 3 in-person site visits, months 0, 3, and 24, and online surveys every 3 months (months 0-24).
This study will use a randomized single-blind controlled design to test the short-term (6 months) and long-term (an additional 18 months) impact of the intervention diets on symptoms of MS including QoL and related outcomes stated above. We will use a fourteen-day run-in period to identify participants who are most likely to be successful in completing study procedures; this process has been effective in our previous studies. Participants who successfully complete all baseline self-reported outcomes and follow all study procedures during the seven-day run-in period will be scheduled for an on-site baseline visit for randomization to one of three diets (time restricted olive oil based (TROO) ketogenic and modified Paleolithic elimination and Dietary Guidelines for America).
On-site study visits will include blood draws, motor, cognitive, vision function assessments, and MRI. Motor assessments will include a 6-minute walk test, 25-foot walk test, 9-hole pegboard to test hand function, symbol digit exercise to test thinking functions, and critical flicker fusion test, ocular coherence tomography and low contrast vision sensitivity to test vision. The study participant will be escorted to the MRI unit to complete a non-contrast MRI of the brain. At the baseline visit, participants will be randomized. Participants assigned to the intervention diets will be given intervention specific educational materials including shopping lists, example menus and recipes, and the study supplements. Study participants randomized to the dietary guidelines for Americans diet will receive emails and/or text messages (approximately 3-6 weeks) to receive resources with websites for the Dietary Guidelines of America, and recent multiple sclerosis-related research that does not involve diet.
Study team will provide fish oil, essential fatty acids, and phosphatidylcholine to the two intervention groups only. The participant will be scheduled for a Zoom video conference meeting with the assigned registered dietitian to review the assigned study diet.
In addition, subjects will collect saliva specimens for microbiome analysis at each of the 3 site study visits (months 0, 3 and 24).
Dietary History Questionnaire III will be completed at months 0, 3, 12 and 24 and will be used to assess adherence to the assigned dietary pattern.
The online questionnaires sent to participants every 3 months will also be used to track supplement intake, medication use, and details about health & life events, MS symptoms, fatigue, quality of life, doctor's appointment, and side effects they may be experiencing.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Iowa
-
Iowa City, Iowa, États-Unis, 52246
- Univeristy of Iowa
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Eligibility for the run-in phase of the study:
Participants will be eligible to enroll in the fourteen-day run-in phase of the study if they meet the following inclusion and exclusion criteria:
INCLUSION CRITERIA:
- A definitive diagnosis of RRMS based on the 2017 revised McDonald Criteria.
- The ability to prepare, or availability of someone to prepare, home-cooked meals.
- Must own a computer, smartphone, or tablet device that has internet access to complete online surveys and capable of running study related applications.
- Must be willing to follow study procedures outlined and explained to them.
- Be between the ages of 18 to 70 at the time of consent.
- Must be able to walk 25 feet without support.
- Willingness to be randomized and follow any of the study diets.
- Must consent to sharing the clinical notes from their primary care and neurology providers during the study period.
EXCLUSION CRITERIA:
- Moderate or severe mental impairment.
- Use of insulin, Coumadin, weight loss medications such as orlistat that causes fat malabsorption.
- Worsening of symptoms resulting in the initiation or change of treatment including steroids (solumedrol, prednisone, etc.) or disease-modifying medications in 4 weeks prior to consent.
- Treatment for cancer by radiation or chemotherapy in 12 months prior to consent, other than skin cancer.
- Diagnosis of clinically significant heart disease, liver disease, kidney disease, or history of oxalate kidney stones.
- Diagnosis of type II diabetes that does not have approval from treating physicians to adopt any of the 3 study diets.
- Clinical diagnosis of moderate to severe psychiatric disease that makes study adherence more difficult (e.g., schizophrenia, bi-polar disease, severe depression and/or anxiety).
- An active eating disorder such as anorexia, bulimia, binge eating, or orthorexia.
- Measurement of BMI <20.
- Confirmation of pregnancy or planning to become pregnant in the next 2 years.
- History of diagnosed fat intolerance/malabsorption such as cholecystectomy or uncontrolled exocrine pancreatic insufficiency.
- Participation in another research study investigating MS treatments, diet, or exercise.
- Presence of a contraindication to completing a brain MRI or having claustrophobia which interferes with completion of MRI studies without the use of sedation.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1 (Modified paleolithic elimination diet).
Modified paleolithic elimination diet. |
nutraceutical supplement
Autres noms:
nutraceutical supplement
Autres noms:
nutraceutical supplement
Autres noms:
|
|
Expérimental: Group 2 (TROO)
Time Restricted Olive Oil Based (TROO) Ketogenic Diet |
nutraceutical supplement
Autres noms:
nutraceutical supplement
Autres noms:
nutraceutical supplement
Autres noms:
|
|
Comparateur actif: Group 3 Control
Usual diet with Dietary Guidelines for Americans Diet information |
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Délai: baseline to 3 Months
|
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 3 Months
|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Délai: baseline to 6 Months
|
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 6 Months
|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Délai: baseline to 12 Months
|
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 12 Months
|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Délai: baseline to 18 Months
|
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 18 Months
|
|
Multiple Sclerosis 54 Quality of Life Mental Health (MS 54 QoL MH)
Délai: baseline to 24 Months
|
Change in (MS 54 QoL MH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 24 Months
|
|
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Délai: baseline to 3 Months
|
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 3 Months
|
|
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Délai: baseline to 6 Months
|
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 6 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Fatigue Impact Scale (MFIS)
Délai: baseline to 3 months
|
Change in MFIS survey questions, scores range from 0-84, lower score is better. |
baseline to 3 months
|
|
Modified Fatigue Impact Scale (MFIS)
Délai: baseline to 6 months
|
Change in MFIS survey questions, scores range from 0-84, lower score is better. |
baseline to 6 months
|
|
Modified Fatigue Impact Scale (MFIS)
Délai: baseline to 12 months
|
Change in MFIS survey questions, scores range from 0-84, lower score is better. |
baseline to 12 months
|
|
Modified Fatigue Impact Scale (MFIS)
Délai: baseline to 18 months
|
Change in MFIS survey questions, scores range from 0-84, lower score is better. |
baseline to 18 months
|
|
Modified Fatigue Impact Scale (MFIS)
Délai: baseline to 24 months
|
Change in MFIS survey questions, scores range from 0-84, lower score is better. |
baseline to 24 months
|
|
Hospital Anxiety Depression Scale (HADS)
Délai: baseline to 3 months
|
Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
baseline to 3 months
|
|
Hospital Anxiety Depression Scale (HADS)
Délai: baseline to 6 months
|
Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
baseline to 6 months
|
|
Hospital Anxiety Depression Scale (HADS)
Délai: baseline to 12 months
|
Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
baseline to 12 months
|
|
Hospital Anxiety Depression Scale (HADS)
Délai: baseline to 18 months
|
Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
baseline to 18 months
|
|
Hospital Anxiety Depression Scale (HADS)
Délai: baseline to 24 months
|
Change in HADS survey question score, a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence |
baseline to 24 months
|
|
Fatigue Severity Scale score (FSS)
Délai: Baseline to 3 months
|
Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
Baseline to 3 months
|
|
Fatigue Severity Scale score (FSS)
Délai: Baseline to 6 months
|
Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
Baseline to 6 months
|
|
Fatigue Severity Scale score (FSS)
Délai: Baseline to 12 months
|
Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
Baseline to 12 months
|
|
Fatigue Severity Scale score (FSS)
Délai: Baseline to 18 months
|
Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
Baseline to 18 months
|
|
Fatigue Severity Scale score (FSS)
Délai: Baseline to 24 months
|
Change in FSS survey question mean scores, scores range from 1-7, lower is better. |
Baseline to 24 months
|
|
Brain volume as measured by non contrast magnetic resonance imaging (MRI)
Délai: baseline to 24 months
|
Change in MRI grey matter brain volume, more is better |
baseline to 24 months
|
|
Brain lesions as measured by non contrast magnetic resonance imaging (MRI)
Délai: baseline to 24 months
|
Change in inflammatory lesions numbers as measured by non contrast brain MRI, fewer is better |
baseline to 24 months
|
|
Timed 25 foot walk test
Délai: baseline to 3 months
|
seconds required to walk 25 feet, lower is better |
baseline to 3 months
|
|
Timed 25 foot walk test
Délai: baseline to 24 months
|
seconds required to walk 25 feet, lower is better |
baseline to 24 months
|
|
9 Hole peg board test
Délai: baseline to 3 months
|
seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better |
baseline to 3 months
|
|
9 Hole peg board test
Délai: baseline to 24 months
|
seconds require to move 9 pegs to various locations on a peg board, fewer seconds is better |
baseline to 24 months
|
|
Low contrast visual acuity
Délai: baseline to 3 months
|
A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better. |
baseline to 3 months
|
|
Low contrast visual acuity
Délai: baseline to 24 months
|
A measure of best corrected vision, measure is log minimal angle of resolution at 2.5% contrast. Lower number is better. |
baseline to 24 months
|
|
Dietary History Questionnaire IIi
Délai: baseline to 12 months
|
Change in dietary intake measured by survey questions |
baseline to 12 months
|
|
Dietary History Questionnaire IIi
Délai: baseline to 3 months
|
Change in dietary intake measured by survey questions |
baseline to 3 months
|
|
Critical flicker fusion
Délai: baseline to 3 months
|
change in The herz at which a flickering light is seen as non-flickering as measured by herz |
baseline to 3 months
|
|
Critical flicker fusion
Délai: baseline to 24 months
|
change in The herz at which a flickering light is seen as non-flickering as measured by herz |
baseline to 24 months
|
|
Ocular Coherence tomography
Délai: baseline
|
Measure of optic nerve and retina depths using infrared light technology |
baseline
|
|
Ocular Coherence tomography
Délai: baseline to 3 months
|
change in the Measure of optic nerve and retina depths using infrared light technology |
baseline to 3 months
|
|
Ocular Coherence tomography
Délai: baseline to 24 months
|
change in the Measure of optic nerve and retina depths using infrared light technology |
baseline to 24 months
|
|
Neurofilament light chain
Délai: baseline to 3 months
|
blood biomarker of neuroaxonal (brain) damage |
baseline to 3 months
|
|
Neurofilament light chain
Délai: baseline to 24 months
|
blood biomarker of neuroaxonal (brain) damage |
baseline to 24 months
|
|
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Délai: baseline to 12 Months
|
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 12 Months
|
|
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Délai: baseline to 18 Months
|
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 18 Months
|
|
Multiple Sclerosis 54 Quality of Life Physical Health (MS 54 QoL PH)
Délai: baseline to 24 Months
|
Change in (MS 54 QoL PH) survey questions mean scores, range 0-100, higher number is better. |
baseline to 24 Months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Terry L Wahls, MD, University of Iowa
Publications et liens utiles
Publications générales
- Wahls TL, Chenard CA, Snetselaar LG. Review of Two Popular Eating Plans within the Multiple Sclerosis Community: Low Saturated Fat and Modified Paleolithic. Nutrients. 2019 Feb 7;11(2):352. doi: 10.3390/nu11020352.
- 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.
- Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 1;11(3):537. doi: 10.3390/nu11030537.
- Titcomb TJ, Bisht B, Moore DD 3rd, Chhonker YS, Murry DJ, Snetselaar LG, Wahls TL. Eating Pattern and Nutritional Risks among People with Multiple Sclerosis Following a Modified Paleolithic Diet. Nutrients. 2020 Jun 20;12(6):1844. doi: 10.3390/nu12061844.
- Lee JE, Bisht B, Hall MJ, Rubenstein LM, Louison R, Klein DT, Wahls TL. A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis. J Am Coll Nutr. 2017 Mar-Apr;36(3):150-168. doi: 10.1080/07315724.2016.1255160. Epub 2017 Apr 10.
- Lee JE, Titcomb TJ, Bisht B, Rubenstein LM, Louison R, Wahls TL. A Modified MCT-Based Ketogenic Diet Increases Plasma beta-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study. J Am Coll Nutr. 2021 Jan;40(1):13-25. doi: 10.1080/07315724.2020.1734988. Epub 2020 Mar 26.
- Chenard CA, Rubenstein LM, Snetselaar LG, Wahls TL. Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern. Nutrients. 2019 Mar 13;11(3):616. doi: 10.3390/nu11030616.
- Irish AK, Erickson CM, Wahls TL, Snetselaar LG, Darling WG. Randomized control trial evaluation of a modified Paleolithic dietary intervention in the treatment of relapsing-remitting multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2017 Jan 4;7:1-18. doi: 10.2147/DNND.S116949. eCollection 2017.
- 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.
- Shemirani F, Klein AM, Groux AR, Kilpatrick R, Brooks L, Ehlinger MA, Darling WG, Magnotta VA, Gill CM, Hoth KF, Mangalam A, Eyck PT, Martinez AS, Hook J, Titcomb TJ, Snetselaar LG, Wahls TL. Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS): a study protocol for a randomized controlled clinical trial. Trials. 2025 Oct 27;26(1):437. doi: 10.1186/s13063-025-09157-2.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies auto-immunes
- Maladies du système immunitaire
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Sclérose en plaques
- Fatigue
- Sclérose en plaques, récurrente-rémittente
- Thérapeutique
- Acides gras
- Lipides
- Régime, nourriture et nutrition
- Phénomènes physiologiques
- Phénomènes physiologiques nutritionnels
- Économie et organisations des soins de santé
- Thérapie de régime
- Thérapie nutritionnelle
- Régime
- Eicosanoïdes
- Acides gras, insaturés
- Régime, glucides restreint
- Huiles
- Graisses alimentaires
- Graisses
- Acides gras, oméga-3
- Graisses alimentaires, insaturés
- Huiles de poisson
- Lipides membranaires
- Glycérophospholipides
- Acides phosphatidiques
- Glycérophosphates
- Phospholipides
- Politique de santé
- Politique publique
- Politiques de contrôle social
- Politique
- Régime, cétogène
- Acide eicosapentaenoïque
- Acides docosahexaenoïques
- Phosphatidylcholines
- Politique nutritionnelle
Autres numéros d'identification d'étude
- 202104639
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Data that has been published will be shared if requested by a scientist conducting a PROSPERO registered meta-analyses who has signed a data use agreement with the University of Iowa Department of Sponsored Programs.
Délai de partage IPD
One year after the specific data has been published.
Critères d'accès au partage IPD
A scientist who has a PROSPERO registered meta-analysis whose meta-analysis protocol has been published. The scientist must contact the PI using their academic email, provide the published PROSPERO registered meta-analysis protocol manuscript, specify which data is being requested. Upon review of the submitted documents, the PI will initiated an outcoing material data use agreement with the Division of Sponsored Programs at the University of Iowa outlining the terms of use. After signing the approved contract, the data will be released to the requesting scientist.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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