(P30-048-24) Efficacy of Diet on Quality of Life in Adults With Multiple Sclerosis (EDQ-MS): Study Protocol for A Randomized Controlled Clinical Trial

Objectives: 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 on quality of life (QoL) among individuals with multiple sclerosis (MS). The secondary objectives are to evaluate the long-term effects on motor function, visual function, fatigue, mood, disease activity, and brain imaging.

Methods: The proposed study will consist of N= 156 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 (an additional 18 months) impact of intervention diets on QoL and related outcomes stated above. On-site study visits will include blood draws, motor, cognitive, and vision function assessments, as well as MRI. Saliva biospecimen will be collected and frozen for future microbiome analyses. Participants assigned to TROO and MPE diets will be given diet-specific educational materials including menus, recipes, and study supplements, including fish oil, essential fatty acids, and phosphatidylcholine. Dietary assessments will be collected by the Diet History Questionnaire III (DHQ III) where participants will login with a unique link with unidentifiable username and password and complete a survey at months 0, 3, 12 and 24. Registered Dietitians (RDs) will deliver the behavioral intervention and provide active support throughout the 24-month intervention period to participants assigned to intervention groups.

Results: N/A

Conclusions: Due to the limitations of prior dietary trials (i.e., small sample size, lack of randomization or a control group, and unclear effects on disease activity and underlying mechanisms), the current state of evidence doesn’t support recommendations for specific diets for MS. Thus, there is an urgent need for rigorous randomized controlled trials to assess the effects of diet on MS symptoms, which is the overall objective of the current study.

Funding Sources: This study is funded by the Carter Chapman Shreve Foundation. FS is supported by the Carter Chapman Shreve Foundation Fellowship for diet and lifestyle research conducted at the University of Iowa.