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Functional Outcomes From Diets in Multiple Sclerosis
RECRUITINGN/ASponsored by University of Alabama at Birmingham
Actively Recruiting
PhaseN/A
SponsorUniversity of Alabama at Birmingham
Started2023-03-20
Est. completion2026-11-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05327322
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
Age: 18 Years – 65 YearsHealthy volunteers accepted
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)
Conditions3
Multiple SclerosisRelapsing Remitting Multiple SclerosisSecondary Progressive Multiple Sclerosis
Locations2 sites
Alabama
1 siteUniversity of Alabama at Birmingham
Birmingham, Alabama, 35294
Missouri
1 siteBrowse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorUniversity of Alabama at Birmingham
Started2023-03-20
Est. completion2026-11-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05327322