Effects of diets on multiple sclerosis outcomes
The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
NA · University of Alabama at Birmingham · NCT05327322
This study is testing whether following a low glycemic load diet or a calorie-restricted diet can improve health and well-being for adults with multiple sclerosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Trial ID | NCT05327322 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of two dietary interventions, low glycemic load and calorie restriction, on various health outcomes in adults with multiple sclerosis. A total of 100 participants will be randomly assigned to one of the two diets for 32 weeks, with the first 16 weeks focused on maintaining weight and the second 16 weeks involving a calorie reduction. The study will assess changes in physical function, cognition, pain, fatigue, mood, and anxiety, as well as inflammation and metabolic biomarkers. Participants will receive meal plans and groceries throughout the trial to support adherence to the dietary interventions.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with relapsing-remitting or secondary progressive multiple sclerosis, who are overweight or obese and able to participate in dietary changes.
Not a fit: Patients who are currently experiencing an MS relapse, unable to walk 25 feet, or have significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical and mental health outcomes for patients with multiple sclerosis through dietary modifications.
How similar studies have performed: Previous studies have shown promising results with dietary interventions in managing symptoms of multiple sclerosis, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Birmingham, Alabama and 1 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Washington University — Saint Louis, Missouri, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Brooks Wingo, PhD — University of Alabama at Birmingham
- Study coordinator: Brooks C Wingo, PhD
- Email: bcwingo@uab.edu
- Phone: (205) 934-5982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis