Functional Outcomes From Diets in Multiple Sclerosis
The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
University of Alabama at Birmingham
100 participants
Mar 20, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria8
- 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)
Interventions
Participants will be provided food to meet GL prescription for the duration of the trial.
Participants will be provided food to meet their prescribed daily calorie intake for the duration of the trial (weight stable in first 16 weeks, weight loss in second 16 weeks).
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05327322