About this trial
The goal of this clinical trial is to learn whether a structured lifestyle program can improve health and wellbeing in people living with multiple sclerosis (MS). The program focuses on four areas: nutrition, physical activity, sleep, and stress management. The study will also examine how lifestyle changes affect biological markers related to inflammation, metabolism, and immune function.
The main questions the study aims to answer are:
Can a 12-week lifestyle program improve fatigue, physical function, sleep, and quality of life in people with MS? Do lifestyle changes influence biological markers related to inflammation, metabolism, and mitochondrial function?
Participants will first complete a 12-week observation period to measure their usual lifestyle and health. After this, they will take part in the 12-week HEAL MS lifestyle program.
Participants will:
Attend four assessment visits at Yas Clinic (baseline, before the intervention, after the intervention, and three months later) Participate in two supervised online exercise sessions per week during the 12-week program Follow a structured nutrition plan, with meals provided during the first two weeks Use a mobile application to log daily habits related to exercise, nutrition, sleep, and stress Complete questionnaires and physical tests and provide blood, saliva, and stool samples during assessment visits
Researchers will analyze these data to understand whether lifestyle interventions can support symptom management and overall health in people living with MS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed MS diagnosis (McDonald criteria)
EDSS score ≤ 6.5 (i.e., ambulatory with or without assistance)
Stable disease-modifying therapy for ≥ 3 months
Age 18-50
Disqualifiers
Significant cognitive impairment affecting app use and comprehension of the intervention
MS relapse within the past 3 months
Pregnancy or planned pregnancy
Unmanaged psychiatric disorders
Trial design
Single group
Treatments tested in this trial
Multi-Domain Lifestyle Intervention
Other interventionThe intervention is a 12-week multi-domain lifestyle program. It targets four behavioral domains: physical activity, nutrition, sleep, and stress regulation. Participants attend twice-weekly supervised online exercise sessions using scalable functional movements performed with bodyweight, resistance bands, and suspension training. The nutrition component provides individualized meal plans based on maintenance calories, emphasizing anti-inflammatory, whole-food nutrition with a macronutrient distribution of approximately 40% carbohydrates, 30% protein, and 30% fat. During the first two weeks, meals are delivered to support adherence. Sleep optimization focuses on circadian-aligned behaviors such as consistent sleep timing and reduced evening light exposure. Stress regulation includes daily breathing exercises, mindfulness practices, and vagal nerve-stimulating techniques. Participants track dadaily behaviors, wellbeing, and wearable data using a billiungual mobile app.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate (Number of Participants Enrolled per Month)
Number of eligible participants enrolled into the study per month, calculated from the number of participants who consent and complete baseline assessment.
Retention Rate (Percentage of Participants Completing All Study Assessments)
Percentage of enrolled participants who complete all four assessment timepoints (baseline, pre-intervention, post-intervention, and 3-month follow-up).
Exercise Adherence (Percentage of Completed Scheduled Exercise Sessions)
Proportion of prescribed exercise sessions attended (twice-weekly supervised sessions) during the 12-week intervention period.
Mobile Application Engagement (Average Daily Completion Rate of App-Based Logs)
Average proportion of days participants complete daily logs (including energy, fatigue, mood, sleep, and adherence tracking) via the HEAL MS mobile application.
Secondary outcomes
Change in Plasma C-Reactive Protein (CRP) Concentration (mg/L)
CRP will be measured using standard clinical blood chemistry assays. Mean change in CRP concentration will be calculated across timepoints to assess systemic inflammation.
Change in Plasma Interleukin-6 (IL-6) Levels (pg/mL)
IL-6 will be quantified using proteomic analysis (Olink platform). Mean change across timepoints will be used to assess inflammatory signaling.
Change in Plasma Proteomic Profile (Normalized Protein Expression Units)
Quantitative proteomic profiling will be performed using the Olink Reveal platform. A composite score derived from selected proteins related to immune function, oxidative stress, and metabolism will be analyzed using normalized protein expression (NPX) values.
Change in Circulating Metabolomic Biomarkers (Concentration Units, mmol/L or µmol/L)
Metabolomic profiling will be conducted using nuclear magnetic resonance (NMR) spectroscopy, quantifying biomarkers related to lipid metabolism, amino acids, and energy pathways. Mean changes in selected metabolites will be analyzed.
Sponsors and contacts
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