Functional Outcomes From Diets in Multiple Sclerosis

NCT05327322 | Recruiting DMC

• 2 other identifiers: 300009050CDMRP-MS210011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Multiple Sclerosis Functional Composite (MSFC)

  The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).

  Baseline

• Multiple Sclerosis Functional Composite (MSFC)

  The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).

  17 weeks

• Multiple Sclerosis Functional Composite (MSFC)

  The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).

  34 weeks

Secondary Outcomes (21)

• Brief International Cognitive Assessment for MS (BICAMS)

  Baseline

• Brief International Cognitive Assessment for MS (BICAMS)

  17 weeks

• Brief International Cognitive Assessment for MS (BICAMS)

  34 weeks

• Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

  Baseline

• Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)

  17 weeks

Other Outcomes (49)

• Blood work: glucose

  Baseline

• Blood work: glucose

  17 weeks

• Blood work: glucose

  34 Weeks

Study Arms (2)

Low Glycemic Load

EXPERIMENTAL

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.

Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support

Standard Glycemic Load

ACTIVE COMPARATOR

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.

Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support

Interventions

Glycemic load BEHAVIORAL

Participants will be provided food to meet GL prescription for the duration of the trial.

Low Glycemic Load; Standard Glycemic Load

Calorie restriction BEHAVIORAL

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).

Low Glycemic Load; Standard Glycemic Load

Behavioral support BEHAVIORAL

All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.

Low Glycemic Load; Standard Glycemic Load

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Washington University School of Medicine: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 38821260 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Interventions

Glycemic Load; Caloric Restriction; Behavior Therapy

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritive Value; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food Quality; Food Technology; Food Industry; Industry; Technology, Industry, and Agriculture; Public Health; Environment and Public Health; Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Brooks Wingo, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooks C Wingo, PhD

CONTACT

(205) 934-5982; bcwingo@uab.edu

Kathryn Green, BS

CONTACT

205-319-1424; kathryngreen@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All staff collecting outcomes data will be randomized to treatment group (low GL vs standard GL).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to follow either a low GL or standard GL diet for 32 weeks. For the first 16 weeks, both groups will eat enough calories to maintain baseline weight. During the second 16 weeks, both groups will reduce calorie intake by 500 kcal/day,

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 14, 2022
• Study Start: March 20, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)