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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
100
Participants will be provided food to meet GL prescription for the duration of the trial.
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).
All participants will receive behavioral supports in the form of email, text, information pages and weekly calls from the study staff to maximize adherence.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Washington University
St Louis, Missouri, United States
Multiple Sclerosis Functional Composite (MSFC)
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Time frame: 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).
Time frame: 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).
Time frame: 34 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
Time frame: 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
Time frame: 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
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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."
Time frame: 34 Weeks