Functional Outcomes From Diets in Multiple Sclerosis (NCT05327322) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Functional Outcomes From Diets in Multiple Sclerosis
United States100 participantsStarted 2023-03-20
Plain-language summary
The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with RRMS or SPMS
* BMI 25-50 kg/m2 (overweight/obese)
* EDSS ≤6.5 (able to walk 100m with or without assistance)
* If on disease-modifying treatment (DMT), stable for 6 months
* If not on DMT, no DMT in previous 6 months
* No expected change to DMT in next 34 weeks
* Responsible for food preparation or have input into food preparation
Exclusion Criteria:
* MS relapse in previous 30 days
* Unable to walk 25 feet with or without assistive device
* Pregnant or breastfeeding
* Current use of insulin or sulfonylurea agents
* Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment
* Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern
* Unable to receive, store, or prepare food according to diet plan
* Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.