Relapsing Remitting Multiple SclerosisFOOD_for_MSNCT05327322
Functional Outcomes From Diets in Multiple Sclerosis
A study testing Glycemic load, Calorie restriction and Behavioral support in people with Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
- What is being tested?
- Glycemic load, Calorie restriction and Behavioral support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Washington University
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Being tested
- Glycemic load, Calorie restriction, Behavioral support
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic loadBehavioural
Participants will be provided food to meet GL prescription for the duration of the trial.
Calorie restrictionBehavioural
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 supportBehavioural
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Functional Composite (MSFC)
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Measured: 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).
Measured: 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).
Measured: 34 weeks
Secondary outcomes (21)
Brief International Cognitive Assessment for MS (BICAMS)
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 34 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start20 Mar 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, United States Department of Defense
- Responsible party
- Principal investigator, Brooks C. Wingo, PhD, University of Alabama at Birmingham
- Investigators
- Brooks Wingo, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327322
- Sponsor's protocol ID
- 300009050
- Other IDs
- CDMRP-MS210011
- Acronym
- FOOD_for_MS
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2022
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38821260
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05327322
- Acronym / sponsor ID
- FOOD_for_MS / 300009050
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, United States Department of Defense
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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,
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Load | Experimental | Behavioral: Glycemic load, Behavioral: Calorie restriction, Behavioral: Behavioral supportThis 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. |
| Standard Glycemic Load | Active comparator | Behavioral: Glycemic load, Behavioral: Calorie restriction, Behavioral: Behavioral supportThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glycemic loadParticipants will be provided food to meet GL prescription for the duration of the trial. | Behavioural | Low Glycemic Load, Standard Glycemic Load |
| Calorie restrictionParticipants 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). | Behavioural | Low Glycemic Load, Standard Glycemic Load |
| Behavioral supportAll participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence. | Behavioural | Low Glycemic Load, Standard Glycemic Load |
Primary outcome
Multiple Sclerosis Functional Composite (MSFC)
Time frame: Baseline
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 17 weeks
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Multiple Sclerosis Functional Composite (MSFC)
Time frame: 34 weeks
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
21 secondary outcomes
Brief International Cognitive Assessment for MS (BICAMS)
Time frame: Baseline
Brief International Cognitive Assessment for MS (BICAMS)
Time frame: 17 weeks
Brief International Cognitive Assessment for MS (BICAMS)
Time frame: 34 weeks
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Time frame: 17 weeks
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Time frame: 34 Weeks
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Time frame: 17 weeks
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Time frame: 34 Weeks
Patient reported outcomes: Fatigue Severity Scale (FSS)
Time frame: Baseline
Patient reported outcomes: Fatigue Severity Scale (FSS)
Time frame: 17 weeks
Patient reported outcomes: Fatigue Severity Scale (FSS)
Time frame: 34 Weeks
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Time frame: Baseline
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Time frame: 17 weeks
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Time frame: 34 Weeks
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Time frame: Baseline
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Time frame: 17 weeks
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Time frame: 34 Weeks
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Time frame: Baseline
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Time frame: 17 weeks
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Time frame: 34 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 38821260Martin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooks Wingo, PhD principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycemic load, Calorie restriction and Behavioral support in people with Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Functional Composite (MSFC) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05327322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.