Image

Functional Outcomes From Diets in Multiple Sclerosis

Functional Outcomes From Diets in Multiple Sclerosis

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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)

Study details
    Relapsing Remitting Multiple Sclerosis
    Secondary Progressive Multiple Sclerosis

NCT05327322

University of Alabama at Birmingham

14 April 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.