RECRUITING

Functional Outcomes From Diets in Multiple Sclerosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis

Quick Facts

Study Start:2023-03-20
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05327322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with RRMS or SPMS
  2. * BMI 25-50 kg/m2 (overweight/obese)
  3. * EDSS ≤6.5 (able to walk 100m with or without assistance)
  4. * If on disease-modifying treatment (DMT), stable for 6 months
  5. * If not on DMT, no DMT in previous 6 months
  6. * No expected change to DMT in next 34 weeks
  7. * Responsible for food preparation or have input into food preparation
  1. * MS relapse in previous 30 days
  2. * Unable to walk 25 feet with or without assistive device
  3. * Pregnant or breastfeeding
  4. * Current use of insulin or sulfonylurea agents
  5. * Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment
  6. * Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern
  7. * Unable to receive, store, or prepare food according to diet plan
  8. * Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)

Contacts and Locations

Study Contact

Brooks C Wingo, PhD
CONTACT
(205) 934-5982
bcwingo@uab.edu
Kathryn Green, BS
CONTACT
205-319-1424
kathryngreen@uabmc.edu

Principal Investigator

Brooks Wingo, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Washington University
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Brooks Wingo, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-03-20
Study Completion Date2026-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsing Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis