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NCT05327322Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
24 Mar 2022
Start date
20 Mar 2023
Primary completion date
1 Nov 2026
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT05327322

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 20 Mar 2023 to the primary completion date, 1 Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • MS relapse in previous 30 days

Other illness

  • Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Washington University
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.