Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS): a study protocol for a randomized controlled clinical trial

TL;DR

This study will test if two special diets improve quality of life for people with multiple sclerosis compared to standard dietary advice.

Contribution

The study introduces a novel randomized trial comparing two specific diets for MS patients to assess their long-term impact on quality of life and disease outcomes.

Findings

The study will evaluate short-term and long-term effects of TROO keto and MPE diets on quality of life and disability in MS patients.

Biospecimens will be collected for future analysis of metabolome and microbiome changes related to the diets.

Behavior change techniques like motivational interviewing will be used to support participants in following the diets.

Abstract

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.

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.

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.

ClinicalTrials.gov, NCT05007483. Registered on August 16, 2021. https://clinicaltrials.gov/study/NCT05007483.

The online version contains supplementary material available at 10.1186/s13063-025-09157-2.

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