Status:
RECRUITING
Functional Outcomes From Diets in Multiple Sclerosis
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Washington University School of Medicine
United States Department of Defense
Conditions:
Relapsing Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 m...
Detailed Description
100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05327322
Start Date
March 20 2023
End Date
January 31 2026
Last Update
April 8 2025
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Washington University
St Louis, Missouri, United States, 63110