Functional Outcomes From Diets in Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis Clinical Trial

— FOOD_for_MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05327322
• Other study ID #: 300009050
• Secondary ID: CDMRP-MS210011
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: January 31, 2026

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Brooks C Wingo, PhD
• Phone: (205) 934-5982
• Email: bcwingo[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis
• Secondary Progressive Multiple Sclerosis

Intervention

Behavioral:
• Glycemic load
Participants will be provided food to meet GL prescription for the duration of the trial.
• 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 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Washington University	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	United States Department of Defense, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood work: glucose	The following serum chemistry will be performed: glucose	Baseline
Other	Blood work: glucose	The following serum chemistry will be performed: glucose	17 weeks
Other	Blood work: glucose	The following serum chemistry will be performed: glucose	34 Weeks
Other	Blood work: insulin	The following serum chemistry will be performed: insulin	Baseline
Other	Blood work: insulin	The following serum chemistry will be performed: insulin	17 weeks
Other	Blood work: insulin	The following serum chemistry will be performed: insulin	34 Weeks
Other	Blood work: lipids	The following serum chemistry will be performed: lipids	Baseline
Other	Blood work: lipids	The following serum chemistry will be performed: lipids	17 weeks
Other	Blood work: lipids	The following serum chemistry will be performed: lipids	34 Weeks
Other	Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	Baseline
Other	Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	17 weeks
Other	Blood work: TNF-a	The following serum chemistry will be performed: TNF-a	34 Weeks
Other	Blood work: IL-6	The following serum chemistry will be performed: IL-6	Baseline
Other	Blood work: IL-6	The following serum chemistry will be performed: IL-6	17 weeks
Other	Blood work: IL-6	The following serum chemistry will be performed: IL-6	34 Weeks
Other	Blood work: IL-17	The following serum chemistry will be performed: IL-17	Baseline
Other	Blood work: IL-17	The following serum chemistry will be performed: IL-17	17 weeks
Other	Blood work: IL-17	The following serum chemistry will be performed: IL-17	34 Weeks
Other	Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	Baseline
Other	Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	17 weeks
Other	Blood work: adiponectin	The following serum chemistry will be performed: adiponectin	34 Weeks
Other	Blood work: leptin	The following serum chemistry will be performed: leptin	Baseline
Other	Blood work: leptin	The following serum chemistry will be performed: leptin	17 weeks
Other	Blood work: leptin	The following serum chemistry will be performed: leptin	34 Weeks
Other	Blood work: T17	The following serum chemistry will be performed: T17	Baseline
Other	Blood work: T17	The following serum chemistry will be performed: T17	17 weeks
Other	Blood work: T17	The following serum chemistry will be performed: T17	34 Weeks
Other	Blood work: NFL	The following serum chemistry will be performed: NFL	Baseline
Other	Blood work: NFL	The following serum chemistry will be performed: NFL	17 weeks
Other	Blood work: NFL	The following serum chemistry will be performed: NFL	34 Weeks
Other	Blood Pressure	Systolic and diastolic blood pressure will be measured.	Baseline
Other	Blood Pressure	Systolic and diastolic blood pressure will be measured.	17 weeks
Other	Blood Pressure	Systolic and diastolic blood pressure will be measured.	34 Weeks
Other	Anthropometric Measures: Weight	Weight will be measured using kilograms.	Baseline
Other	Anthropometric Measures: Weight	Weight will be measured using kilograms.	17 weeks
Other	Anthropometric Measures: Weight	Weight will be measured using kilograms.	34 Weeks
Other	Anthropometric Measures: Height	Height will be measured using meters.	Baseline
Other	Anthropometric Measures: Height	Height will be measured using meters.	17 weeks
Other	Anthropometric Measures: Height	Height will be measured using meters.	34 weeks
Other	Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	Baseline
Other	Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	17 weeks
Other	Anthropometric Measures: Waist circumference	Waist circumference will be measured using inches.	34 Weeks
Other	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
Other	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
Other	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
Other	Detailed body composition	The investigators will perform MRI to assess adipose distribution in the abdomen and thigh	Baseline
Other	Detailed body composition	The investigators will perform MRI to assess adipose distribution in the abdomen and thigh	34 Weeks
Other	Neuroinflammation	The investigators will perform diffusion basis spectrum imaging (DBSI) MRI to assess neuroinflammation at WUSTL only	Baseline
Other	Neuroinflammation	The investigators will perform DBSI MRI to assess neuroinflammation at WUSTL only	34 Weeks
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Brief International Cognitive Assessment for MS (BICAMS)	The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test	17 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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