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Active, Not Recruiting

NCT Number: NCT05327322

Functional Outcomes From Diets 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Progressive Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Glycemic load

Behavioral

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

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).

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • United States Department of Defense
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: FOOD_for_MS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2022
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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