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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-MS210011 | Other Grant/Funding Number | US Department of Defense |
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycemic load | Behavioral | Participants will be provided food to meet GL prescription for the duration of the trial. |
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| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brooks Wingo, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Washington University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38821260 | Derived | 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. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000067940 | Glycemic Load |
| D031204 | Caloric Restriction |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D009753 | Nutritive Value |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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,
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All staff collecting outcomes data will be randomized to treatment group (low GL vs standard GL).
| 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. |
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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 |
| 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 |
| St Louis |
| Missouri |
| 63110 |
| United States |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D063427 | Food Quality |
| D005524 | Food Technology |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |