Functional Outcomes From Diets in Multiple Sclerosis (FOOD_for_MS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
• Intervention / Treatment: Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief International Cognitive Assessment for MS (BICAMS)	The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test	Baseline
Brief International Cognitive Assessment for MS (BICAMS)	The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test	17 weeks
Brief International Cognitive Assessment for MS (BICAMS)	The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test	34 weeks
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)	The HADS contains 14 items that measure the frequency of anxiety and depressive symptoms over the past week. The anxiety questions are scaled 0-3 with 0 representing higher anxiety to 3 representing no anxiety. The depression questions are scaled from 0 indicating no depression to 3 indicating more signs of depression.	Baseline
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)	The HADS contains 14 items that measure the frequency of anxiety and depressive symptoms over the past week. The anxiety questions are scaled 0-3 with 0 representing higher anxiety to 3 representing no anxiety. The depression questions are scaled from 0 indicating no depression to 3 indicating more signs of depression.	17 weeks
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)	The HADS contains 14 items that measure the frequency of anxiety and depressive symptoms over the past week. The anxiety questions are scaled 0-3 with 0 representing higher anxiety to 3 representing no anxiety. The depression questions are scaled from 0 indicating no depression to 3 indicating more signs of depression.	34 Weeks
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)	The MFIS is a 21-item measure of physical, cognitive, and psychosocial impact of fatigue on daily life over the past 4 weeks. The scale ranges from 0 to 4 with 0 being never have issues regarding fatigue to 4 representing fatigue greatly affecting the participants life.	Baseline
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)	The MFIS is a 21-item measure of physical, cognitive, and psychosocial impact of fatigue on daily life over the past 4 weeks. The scale ranges from 0 to 4 with 0 being never have issues regarding fatigue to 4 representing fatigue greatly affecting the participants life.	17 weeks
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)	The MFIS is a 21-item measure of physical, cognitive, and psychosocial impact of fatigue on daily life over the past 4 weeks. The scale ranges from 0 to 4 with 0 being never have issues regarding fatigue to 4 representing fatigue greatly affecting the participants life.	34 Weeks
Patient reported outcomes: Fatigue Severity Scale (FSS)	The FSS is a 9-item unidimensional measure of fatigue and its disabling consequences over the past week in medical populations including MS. The score is from 1 to 7 with 1 representing strongly disagreeing that fatigue has an impact on them to 7 representing strongly agreeing fatigue has an impact on the participants.	Baseline
Patient reported outcomes: Fatigue Severity Scale (FSS)	The FSS is a 9-item unidimensional measure of fatigue and its disabling consequences over the past week in medical populations including MS. The score is from 1 to 7 with 1 representing strongly disagreeing that fatigue has an impact on them to 7 representing strongly agreeing fatigue has an impact on the participants.	17 weeks
Patient reported outcomes: Fatigue Severity Scale (FSS)	The FSS is a 9-item unidimensional measure of fatigue and its disabling consequences over the past week in medical populations including MS. The score is from 1 to 7 with 1 representing strongly disagreeing that fatigue has an impact on them to 7 representing strongly agreeing fatigue has an impact on the participants.	34 Weeks
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)	The participants will be asked to rate their global fatigue on a scale of 0-10 with 0 being the worst fatigued and 10 being normal.	Baseline
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)	The participants will be asked to rate their global fatigue on a scale of 0-10 with 0 being the worst fatigued and 10 being normal.	17 weeks
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)	The participants will be asked to rate their global fatigue on a scale of 0-10 with 0 being the worst fatigued and 10 being normal.	34 Weeks
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)	The SF-MPQ has a 15-item adjective checklist that captures sensory and affective dimensions of pain experienced over the past week. Questions are scored from 0-10. Zero representing no pain and 10 representing the highest pain level.	Baseline
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)	The SF-MPQ has a 15-item adjective checklist that captures sensory and affective dimensions of pain experienced over the past week. Questions are scored from 0-10. Zero representing no pain and 10 representing the highest pain level.	17 weeks
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)	The SF-MPQ has a 15-item adjective checklist that captures sensory and affective dimensions of pain experienced over the past week. Questions are scored from 0-10. Zero representing no pain and 10 representing the highest pain level.	34 Weeks
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)	The questionnaire has fill in the blank questions along with questions that are rated on a scale. The scale rating is "not during the past month" to "three or more times per week."	Baseline
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)	The questionnaire has fill in the blank questions along with questions that are rated on a scale. The scale rating is "not during the past month" to "three or more times per week."	17 weeks
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)	The questionnaire has fill in the blank questions along with questions that are rated on a scale. The scale rating is "not during the past month" to "three or more times per week."	34 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood work: glucose	The following serum chemistry will be performed: glucose	Baseline
Blood work: glucose	The following serum chemistry will be performed: glucose	17 weeks
Blood work: glucose	The following serum chemistry will be performed: glucose	34 Weeks
Blood work: insulin	The following serum chemistry will be performed: insulin	Baseline
Blood work: insulin	The following serum chemistry will be performed: insulin	17 weeks
Blood work: insulin	The following serum chemistry will be performed: insulin	34 Weeks
Blood work: lipids	The following serum chemistry will be performed: lipids	Baseline
Blood work: lipids	The following serum chemistry will be performed: lipids	17 weeks
Blood work: lipids	The following serum chemistry will be performed: lipids	34 Weeks
Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	Baseline
Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	17 weeks
Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	34 Weeks
Blood work: IL-6	The following serum chemistry will be performed: IL-6	Baseline
Blood work: IL-6	The following serum chemistry will be performed: IL-6	17 weeks
Blood work: IL-6	The following serum chemistry will be performed: IL-6	34 Weeks
Blood work: IL-17	The following serum chemistry will be performed: IL-17	Baseline
Blood work: IL-17	The following serum chemistry will be performed: IL-17	17 weeks
Blood work: IL-17	The following serum chemistry will be performed: IL-17	34 Weeks
Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	Baseline
Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	17 weeks
Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	34 Weeks
Blood work: leptin	The following serum chemistry will be performed: leptin	Baseline
Blood work: leptin	The following serum chemistry will be performed: leptin	17 weeks
Blood work: leptin	The following serum chemistry will be performed: leptin	34 Weeks
Blood work: T17	The following serum chemistry will be performed: T17	Baseline
Blood work: T17	The following serum chemistry will be performed: T17	17 weeks
Blood work: T17	The following serum chemistry will be performed: T17	34 Weeks
Blood work: NFL	The following serum chemistry will be performed: NFL	Baseline
Blood work: NFL	The following serum chemistry will be performed: NFL	17 weeks
Blood work: NFL	The following serum chemistry will be performed: NFL	34 Weeks
Blood Pressure	Systolic and diastolic blood pressure will be measured.	Baseline
Blood Pressure	Systolic and diastolic blood pressure will be measured.	17 weeks
Blood Pressure	Systolic and diastolic blood pressure will be measured.	34 Weeks
Anthropometric Measures: Weight	Weight will be measured using kilograms.	Baseline
Anthropometric Measures: Weight	Weight will be measured using kilograms.	17 weeks
Anthropometric Measures: Weight	Weight will be measured using kilograms.	34 Weeks
Anthropometric Measures: Height	Height will be measured using meters.	Baseline
Anthropometric Measures: Height	Height will be measured using meters.	17 weeks
Anthropometric Measures: Height	Height will be measured using meters.	34 weeks
Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	Baseline
Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	17 weeks
Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	34 Weeks
Total Body Composition	Dual energy x-ray absorptiometry (DXA) Total and regional body composition will be measured on a Lunar Prodigy with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Participants will undergo a total body scan requiring about 20 minutes, while lying on their back on a padded table with metal objects removed. The scan provides estimates of soft tissue attenuation ratios, fat and lean tissue mass, and bone mineral density. Individuals who are too large to scan in a single scan will be scanned twice (one scan for the left half of body, one for the right). The software is able to merge the two scans to assess total body composition. All women of child-bearing age will be required to complete a pregnancy test in the lab prior to DXA scan.	Baseline
Total Body Composition	Dual energy x-ray absorptiometry (DXA) Total and regional body composition will be measured on a Lunar Prodigy with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Participants will undergo a total body scan requiring about 20 minutes, while lying on their back on a padded table with metal objects removed. The scan provides estimates of soft tissue attenuation ratios, fat and lean tissue mass, and bone mineral density. Individuals who are too large to scan in a single scan will be scanned twice (one scan for the left half of body, one for the right). The software is able to merge the two scans to assess total body composition. All women of child-bearing age will be required to complete a pregnancy test in the lab prior to DXA scan.	17 weeks
Total Body Composition	Dual energy x-ray absorptiometry (DXA) Total and regional body composition will be measured on a Lunar Prodigy with enCORE software version 13.6 (GE Healthcare, Chicago, IL). Participants will undergo a total body scan requiring about 20 minutes, while lying on their back on a padded table with metal objects removed. The scan provides estimates of soft tissue attenuation ratios, fat and lean tissue mass, and bone mineral density. Individuals who are too large to scan in a single scan will be scanned twice (one scan for the left half of body, one for the right). The software is able to merge the two scans to assess total body composition. All women of child-bearing age will be required to complete a pregnancy test in the lab prior to DXA scan.	34 Weeks
Detailed body composition	The investigators will perform MRI to assess adipose distribution in the abdomen and thigh	Baseline
Detailed body composition	The investigators will perform MRI to assess adipose distribution in the abdomen and thigh	34 Weeks
Neuroinflammation	The investigators will perform diffusion basis spectrum imaging (DBSI) MRI to assess neuroinflammation at WUSTL only	Baseline
Neuroinflammation	The investigators will perform DBSI MRI to assess neuroinflammation at WUSTL only	34 Weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Washington University School of Medicine; United States Department of Defense
• Investigators: Principal Investigator: Brooks Wingo, PhD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Therapeutics; Public Health; Environment and Public Health; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Psychotherapy; Behavioral Disciplines and Activities; Technology, Industry, and Agriculture; Diet Therapy; Nutrition Therapy; Diet; Industry; Energy Intake; Food Industry; Food Quality; Food Technology; Nutritive Value; Behavior Therapy; Caloric Restriction; Glycemic Load
• Other Study ID Numbers: 300009050; CDMRP-MS210011 (Other Grant/Funding Number: US Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No