NCT05327322

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. During the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. Participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase. All participants will receive meal plans and groceries for the duration of the trial.

Conditions

• Relapsing Remitting Multiple Sclerosis
• Secondary Progressive Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	Glycemic load	Participants will be provided food to meet GL prescription for the duration of the trial.
BEHAVIORAL	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	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.

Timeline

• Start date: 2023-03-20
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2022-04-14
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States