Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-03-20
2026-11-01
Brief Summary
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Detailed Description
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All participants will receive meal plans and groceries for the duration of the trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Low Glycemic Load
This group will be prescribed a daily GL of \<45 points/1000 kcal and 25% of daily calorie intake from carbohydrates. This group will be provided few processed foods. During the first 16 weeks, this group will eat enough calories to maintain baseline weight, and will reduce daily calorie intake by 500 kcal/day in the second 16 weeks.
Glycemic load
Participants will be provided food to meet GL prescription for the duration of the trial.
Calorie restriction
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).
Behavioral support
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
Standard Glycemic Load
This group will be prescribed a daily GL of \>75 points/1000kcal and 60% of daily calorie intake from carbohydrates. This group will be provided more processed foods than the low GL group. During the first 16 weeks, this group will eat enough calories to maintain baseline weight, and will reduce daily calorie intake by 500 kcal/day in the second 16 weeks.
Glycemic load
Participants will be provided food to meet GL prescription for the duration of the trial.
Calorie restriction
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).
Behavioral support
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
Interventions
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Glycemic load
Participants will be provided food to meet GL prescription for the duration of the trial.
Calorie restriction
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).
Behavioral support
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Washington University School of Medicine
OTHER
United States Department of Defense
FED
Responsible Party
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Brooks C. Wingo, PhD
Associate Professor
Principal Investigators
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Brooks Wingo, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Washington University
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Martin K, Cofield SS, Cross AH, Goss AM, Raji CA, Rinker JR, Wu GF, Blair J, Fuchs A, Ghezzi L, Green K, Pace F, Pastori G, Taylor MG, Piccio L, Wingo BC. Functional outcomes of diets in multiple sclerosis (FOOD for MS): Protocol for a parallel arm randomized feeding trial for low glycemic load and calorie restriction. Contemp Clin Trials. 2024 Aug;143:107584. doi: 10.1016/j.cct.2024.107584. Epub 2024 May 29.
Other Identifiers
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CDMRP-MS210011
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300009050
Identifier Type: -
Identifier Source: org_study_id
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