Functional Outcomes From Diets in Multiple Sclerosis (FOOD_for_MS)

• ClinicalTrials.gov Identifier: NCT05327322
• Recruitment Status: Not yet recruiting
• First Posted: April 14, 2022
• Last Update Posted: January 6, 2023
• Sponsor: University of Alabama at Birmingham
• Collaborators: Washington University School of Medicine; United States Department of Defense
• Information provided by (Responsible Party): Brooks C. Wingo, PhD, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Relapsing Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis	Behavioral: Glycemic load; Behavioral: Calorie restriction; Behavioral: Behavioral support	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Outcomes Assessor)
• Masking Description: All staff collecting outcomes data will be randomized to treatment group (low GL vs standard GL).
• Primary Purpose: Other
• Official Title: The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
• Estimated Study Start Date: March 10, 2023
• Estimated Primary Completion Date: January 31, 2026
• Estimated Study Completion Date: January 31, 2026

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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).
3. 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).

Secondary Outcome Measures :

1. Brief International Cognitive Assessment for MS (BICAMS) [ Time Frame: Baseline ]
   The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
2. Brief International Cognitive Assessment for MS (BICAMS) [ Time Frame: 17 weeks ]
   The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
3. Brief International Cognitive Assessment for MS (BICAMS) [ Time Frame: 34 weeks ]
   The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
4. Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline ]
   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.
5. Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 17 weeks ]
   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.
6. Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 34 Weeks ]
   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.
7. Patient reported outcomes: Modified Fatigue Impact Scale (MFIS) [ Time Frame: Baseline ]
   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.
8. Patient reported outcomes: Modified Fatigue Impact Scale (MFIS) [ Time Frame: 17 weeks ]
   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.
9. Patient reported outcomes: Modified Fatigue Impact Scale (MFIS) [ Time Frame: 34 Weeks ]
   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.
10. Patient reported outcomes: Fatigue Severity Scale (FSS) [ Time Frame: Baseline ]
    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.
11. Patient reported outcomes: Fatigue Severity Scale (FSS) [ Time Frame: 17 weeks ]
    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.
12. Patient reported outcomes: Fatigue Severity Scale (FSS) [ Time Frame: 34 Weeks ]
    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.
13. Patient reported outcomes: Visual Analog Fatigue Scale (VAFS) [ Time Frame: Baseline ]
    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.
14. Patient reported outcomes: Visual Analog Fatigue Scale (VAFS) [ Time Frame: 17 weeks ]
    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.
15. Patient reported outcomes: Visual Analog Fatigue Scale (VAFS) [ Time Frame: 34 Weeks ]
    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.
16. Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2) [ Time Frame: Baseline ]
    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. Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2) [ Time Frame: 17 weeks ]
    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.
18. Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2) [ Time Frame: 34 Weeks ]
    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.
19. Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Baseline ]
    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."
20. Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 17 weeks ]
    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."
21. Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 34 Weeks ]
    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."

Other Outcome Measures:

1. Blood work: glucose [ Time Frame: Baseline ]
   The following serum chemistry will be performed: glucose
2. Blood work: glucose [ Time Frame: 17 weeks ]
   The following serum chemistry will be performed: glucose
3. Blood work: glucose [ Time Frame: 34 Weeks ]
   The following serum chemistry will be performed: glucose
4. Blood work: insulin [ Time Frame: Baseline ]
   The following serum chemistry will be performed: insulin
5. Blood work: insulin [ Time Frame: 17 weeks ]
   The following serum chemistry will be performed: insulin
6. Blood work: insulin [ Time Frame: 34 Weeks ]
   The following serum chemistry will be performed: insulin
7. Blood work: lipids [ Time Frame: Baseline ]
   The following serum chemistry will be performed: lipids
8. Blood work: lipids [ Time Frame: 17 weeks ]
   The following serum chemistry will be performed: lipids
9. Blood work: lipids [ Time Frame: 34 Weeks ]
   The following serum chemistry will be performed: lipids
10. Blood work: TNF-a [ Time Frame: Baseline ]
    The following serum chemistry will be performed: TNF-a
11. Blood work: TNF-a [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: TNF-a
12. Blood work: TNF-a [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: TNF-a
13. Blood work: IL-6 [ Time Frame: Baseline ]
    The following serum chemistry will be performed: IL-6
14. Blood work: IL-6 [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: IL-6
15. Blood work: IL-6 [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: IL-6
16. Blood work: IL-17 [ Time Frame: Baseline ]
    The following serum chemistry will be performed: IL-17
17. Blood work: IL-17 [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: IL-17
18. Blood work: IL-17 [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: IL-17
19. Blood work: adiponectin [ Time Frame: Baseline ]
    The following serum chemistry will be performed: adiponectin
20. Blood work: adiponectin [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: adiponectin
21. Blood work: adiponectin [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: adiponectin
22. Blood work: leptin [ Time Frame: Baseline ]
    The following serum chemistry will be performed: leptin
23. Blood work: leptin [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: leptin
24. Blood work: leptin [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: leptin
25. Blood work: T17 [ Time Frame: Baseline ]
    The following serum chemistry will be performed: T17
26. Blood work: T17 [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: T17
27. Blood work: T17 [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: T17
28. Blood work: NFL [ Time Frame: Baseline ]
    The following serum chemistry will be performed: NFL
29. Blood work: NFL [ Time Frame: 17 weeks ]
    The following serum chemistry will be performed: NFL
30. Blood work: NFL [ Time Frame: 34 Weeks ]
    The following serum chemistry will be performed: NFL
31. Blood Pressure [ Time Frame: Baseline ]
    Systolic and diastolic blood pressure will be measured.
32. Blood Pressure [ Time Frame: 17 weeks ]
    Systolic and diastolic blood pressure will be measured.
33. Blood Pressure [ Time Frame: 34 Weeks ]
    Systolic and diastolic blood pressure will be measured.
34. Anthropometric Measures: Weight [ Time Frame: Baseline ]
    Weight will be measured using kilograms.
35. Anthropometric Measures: Weight [ Time Frame: 17 weeks ]
    Weight will be measured using kilograms.
36. Anthropometric Measures: Weight [ Time Frame: 34 Weeks ]
    Weight will be measured using kilograms.
37. Anthropometric Measures: Height [ Time Frame: Baseline ]
    Height will be measured using meters.
38. Anthropometric Measures: Height [ Time Frame: 17 weeks ]
    Height will be measured using meters.
39. Anthropometric Measures: Height [ Time Frame: 34 weeks ]
    Height will be measured using meters.
40. Anthropometric Measures: Waist circumference [ Time Frame: Baseline ]
    Waist circumference will be measured using inches.
41. Anthropometric Measures: Waist circumference [ Time Frame: 17 weeks ]
    Waist circumference will be measured using inches.
42. Anthropometric Measures: Waist circumference [ Time Frame: 34 Weeks ]
    Waist circumference will be measured using inches.
43. Total Body Composition [ Time Frame: Baseline ]
    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.
44. Total Body Composition [ Time Frame: 17 weeks ]
    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.
45. Total Body Composition [ Time Frame: 34 Weeks ]
    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.
46. Detailed body composition [ Time Frame: Baseline ]
    The investigators will perform MRI to assess adipose distribution in the abdomen and thigh
47. Detailed body composition [ Time Frame: 34 Weeks ]
    The investigators will perform MRI to assess adipose distribution in the abdomen and thigh
48. Neuroinflammation [ Time Frame: Baseline ]
    The investigators will perform diffusion basis spectrum imaging (DBSI) MRI to assess neuroinflammation at WUSTL only
49. Neuroinflammation [ Time Frame: 34 Weeks ]
    The investigators will perform DBSI MRI to assess neuroinflammation at WUSTL only

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Contacts

Contact: Brooks C Wingo, PhD; (205) 934-5982; bcwingo@uab.edu

Contact: Kathryn Green, BS; 205-319-1424; kathryngreen@uabmc.edu

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Contact: Brooks C Wingo, PhD 205-934-5982 bcwingo@uab.edu

Contact: Kathryn Green, BS kathryngreen@uabmc.edu

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

Contact: Laura Piccio, MD, PhD picciol@wustl.edu

Contact: Courtney Dula dulac@wustl.edu

Sponsors and Collaborators

University of Alabama at Birmingham

Washington University School of Medicine

United States Department of Defense

Investigators

• Principal Investigator: Brooks Wingo, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Brooks C. Wingo, PhD, Associate Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT05327322
• Other Study ID Numbers: 300009050; CDMRP-MS210011 ( Other Grant/Funding Number: US Department of Defense )
• First Posted: April 14, 2022
• Last Update Posted: January 6, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases