Trials · 2025
Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS): a study protocol for a randomized controlled clinical trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Shemirani Farnoosh, Klein Anna M, Groux Allison R, Kilpatrick Rachael, Brooks Lisa, Ehlinger Mary A, Darling Warren G, Magnotta Vincent A, Gill Christine M, Hoth Karin F, Mangalam Ashutosh, Eyck Patrick Ten, Martinez Arturo S, Hook Jordan, Titcomb Tyler J, Snetselaar Linda G, Wahls Terry L
Аннотация
BACKGROUND: The primary objective of this study is to evaluate the efficacy of two dietary interventions, time-restricted olive oil-based (TROO) ketogenic and modified Paleolithic elimination (MPE), compared to usual care control group receiving Dietary Guidelines for Americans (DGA) resources, on quality of life (QoL) among individuals with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives are to evaluate the long-term effects on functional disability, fatigue, mood, motor, ocular and cognitive function, and disease activity.
METHODS: The proposed study will consist of 162 study participants attending 3 in-person site visits at months 0, 3, and 24, with online surveys every 3 months. This study will use a randomized, single-blind, controlled design to investigate the short-term (6 months) and long-term (24 months) efficacy of intervention diets on QoL and related outcomes stated above. On-site study visits will include motor, ocular and cognitive function, as well as magnetic resonance analyses. Blood and saliva biospecimens will be collected and frozen for future metabolome and microbiome analyses, respectively. Participants assigned to TROO keto and MPE diets will be given diet-specific educational materials and dietary supplements. Usual care control group will be given DGA resources and monthly educational resources. Dietary assessments will be collected by the Diet History Questionnaire III (DHQ III) at months 0, 3, 12 and 24. Registered Dietitian Nutritionists (RDNs) will deliver the dietary intervention to the TROO and MPE groups, using Social Cognitive Theory (SCT), Self-Determination Theory, and Motivational Interviewing (MI) techniques to facilitate effective behavior change.
DISCUSSION: There is an unmet need for rigorous randomized controlled trials to assess the efficacy of dietary interventions on MS-related symptoms and disease activity. The findings from this study will provide necessary information regarding the role of specific dietary interventions in MS care.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05007483. Registered on August 16, 2021. https://clinicaltrials.gov/study/NCT05007483 .
METHODS: The proposed study will consist of 162 study participants attending 3 in-person site visits at months 0, 3, and 24, with online surveys every 3 months. This study will use a randomized, single-blind, controlled design to investigate the short-term (6 months) and long-term (24 months) efficacy of intervention diets on QoL and related outcomes stated above. On-site study visits will include motor, ocular and cognitive function, as well as magnetic resonance analyses. Blood and saliva biospecimens will be collected and frozen for future metabolome and microbiome analyses, respectively. Participants assigned to TROO keto and MPE diets will be given diet-specific educational materials and dietary supplements. Usual care control group will be given DGA resources and monthly educational resources. Dietary assessments will be collected by the Diet History Questionnaire III (DHQ III) at months 0, 3, 12 and 24. Registered Dietitian Nutritionists (RDNs) will deliver the dietary intervention to the TROO and MPE groups, using Social Cognitive Theory (SCT), Self-Determination Theory, and Motivational Interviewing (MI) techniques to facilitate effective behavior change.
DISCUSSION: There is an unmet need for rigorous randomized controlled trials to assess the efficacy of dietary interventions on MS-related symptoms and disease activity. The findings from this study will provide necessary information regarding the role of specific dietary interventions in MS care.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05007483. Registered on August 16, 2021. https://clinicaltrials.gov/study/NCT05007483 .