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Functional Outcomes From Diets in Multiple Sclerosis (FOOD_for_MS)

Primary Purpose

Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glycemic load
Calorie restriction
Behavioral support
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Glycemic Load

Standard Glycemic Load

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Multiple Sclerosis Functional Composite (MSFC)
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Multiple Sclerosis Functional Composite (MSFC)
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Multiple Sclerosis Functional Composite (MSFC)
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).

Secondary Outcome Measures

Brief International Cognitive Assessment for MS (BICAMS)
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Brief International Cognitive Assessment for MS (BICAMS)
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Brief International Cognitive Assessment for MS (BICAMS)
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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."
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."
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."

Full Information

First Posted
March 24, 2022
Last Updated
March 22, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
Washington University School of Medicine, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT05327322
Brief Title
Functional Outcomes From Diets in Multiple Sclerosis
Acronym
FOOD_for_MS
Official Title
The Impact of Diet Quality and Calorie Restriction on Physical Function and Patient Reported Outcomes in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Washington University School of Medicine, United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
All staff collecting outcomes data will be randomized to treatment group (low GL vs standard GL).
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Glycemic Load
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Glycemic Load
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Glycemic load
Intervention Description
Participants will be provided food to meet GL prescription for the duration of the trial.
Intervention Type
Behavioral
Intervention Name(s)
Calorie restriction
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Behavioral support
Intervention Description
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 Outcome Measure Information:
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Time Frame
Baseline
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Time Frame
17 weeks
Title
Multiple Sclerosis Functional Composite (MSFC)
Description
The MSFC includes a timed T25FW, 9-hole peg test (9HPT), and the Paced Auditory Serial Addition Test (PASAT).
Time Frame
34 weeks
Secondary Outcome Measure Information:
Title
Brief International Cognitive Assessment for MS (BICAMS)
Description
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Time Frame
Baseline
Title
Brief International Cognitive Assessment for MS (BICAMS)
Description
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Time Frame
17 weeks
Title
Brief International Cognitive Assessment for MS (BICAMS)
Description
The BICAMS includes the Single Digit Modalities Test, California Verbal Learning Test, and Brief Visuospatial Memory Test
Time Frame
34 weeks
Title
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Description
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
Baseline
Title
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Patient reported outcomes: Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Description
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
Title
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Description
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
Title
Patient reported outcomes: Modified Fatigue Impact Scale (MFIS)
Description
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
Title
Patient reported outcomes: Fatigue Severity Scale (FSS)
Description
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
Title
Patient reported outcomes: Fatigue Severity Scale (FSS)
Description
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
Title
Patient reported outcomes: Fatigue Severity Scale (FSS)
Description
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
Title
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Description
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
Title
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Description
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
Title
Patient reported outcomes: Visual Analog Fatigue Scale (VAFS)
Description
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
Title
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Description
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
Title
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Description
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
Title
Patient reported outcomes: Short-form McGill Pain Questionnaire Revised (SF-MPQ-2)
Description
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
Title
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Description
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
Title
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Description
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
Title
Patient reported outcomes: Pittsburg Sleep Quality Index (PSQI)
Description
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
Other Pre-specified Outcome Measures:
Title
Blood work: glucose
Description
The following serum chemistry will be performed: glucose
Time Frame
Baseline
Title
Blood work: glucose
Description
The following serum chemistry will be performed: glucose
Time Frame
17 weeks
Title
Blood work: glucose
Description
The following serum chemistry will be performed: glucose
Time Frame
34 Weeks
Title
Blood work: insulin
Description
The following serum chemistry will be performed: insulin
Time Frame
Baseline
Title
Blood work: insulin
Description
The following serum chemistry will be performed: insulin
Time Frame
17 weeks
Title
Blood work: insulin
Description
The following serum chemistry will be performed: insulin
Time Frame
34 Weeks
Title
Blood work: lipids
Description
The following serum chemistry will be performed: lipids
Time Frame
Baseline
Title
Blood work: lipids
Description
The following serum chemistry will be performed: lipids
Time Frame
17 weeks
Title
Blood work: lipids
Description
The following serum chemistry will be performed: lipids
Time Frame
34 Weeks
Title
Blood work: TNF-a
Description
The following serum chemistry will be performed: TNF-a
Time Frame
Baseline
Title
Blood work: TNF-a
Description
The following serum chemistry will be performed: TNF-a
Time Frame
17 weeks
Title
Blood work: TNF-a
Description
The following serum chemistry will be performed: TNF-a
Time Frame
34 Weeks
Title
Blood work: IL-6
Description
The following serum chemistry will be performed: IL-6
Time Frame
Baseline
Title
Blood work: IL-6
Description
The following serum chemistry will be performed: IL-6
Time Frame
17 weeks
Title
Blood work: IL-6
Description
The following serum chemistry will be performed: IL-6
Time Frame
34 Weeks
Title
Blood work: IL-17
Description
The following serum chemistry will be performed: IL-17
Time Frame
Baseline
Title
Blood work: IL-17
Description
The following serum chemistry will be performed: IL-17
Time Frame
17 weeks
Title
Blood work: IL-17
Description
The following serum chemistry will be performed: IL-17
Time Frame
34 Weeks
Title
Blood work: adiponectin
Description
The following serum chemistry will be performed: adiponectin
Time Frame
Baseline
Title
Blood work: adiponectin
Description
The following serum chemistry will be performed: adiponectin
Time Frame
17 weeks
Title
Blood work: adiponectin
Description
The following serum chemistry will be performed: adiponectin
Time Frame
34 Weeks
Title
Blood work: leptin
Description
The following serum chemistry will be performed: leptin
Time Frame
Baseline
Title
Blood work: leptin
Description
The following serum chemistry will be performed: leptin
Time Frame
17 weeks
Title
Blood work: leptin
Description
The following serum chemistry will be performed: leptin
Time Frame
34 Weeks
Title
Blood work: T17
Description
The following serum chemistry will be performed: T17
Time Frame
Baseline
Title
Blood work: T17
Description
The following serum chemistry will be performed: T17
Time Frame
17 weeks
Title
Blood work: T17
Description
The following serum chemistry will be performed: T17
Time Frame
34 Weeks
Title
Blood work: NFL
Description
The following serum chemistry will be performed: NFL
Time Frame
Baseline
Title
Blood work: NFL
Description
The following serum chemistry will be performed: NFL
Time Frame
17 weeks
Title
Blood work: NFL
Description
The following serum chemistry will be performed: NFL
Time Frame
34 Weeks
Title
Blood Pressure
Description
Systolic and diastolic blood pressure will be measured.
Time Frame
Baseline
Title
Blood Pressure
Description
Systolic and diastolic blood pressure will be measured.
Time Frame
17 weeks
Title
Blood Pressure
Description
Systolic and diastolic blood pressure will be measured.
Time Frame
34 Weeks
Title
Anthropometric Measures: Weight
Description
Weight will be measured using kilograms.
Time Frame
Baseline
Title
Anthropometric Measures: Weight
Description
Weight will be measured using kilograms.
Time Frame
17 weeks
Title
Anthropometric Measures: Weight
Description
Weight will be measured using kilograms.
Time Frame
34 Weeks
Title
Anthropometric Measures: Height
Description
Height will be measured using meters.
Time Frame
Baseline
Title
Anthropometric Measures: Height
Description
Height will be measured using meters.
Time Frame
17 weeks
Title
Anthropometric Measures: Height
Description
Height will be measured using meters.
Time Frame
34 weeks
Title
Anthropometric Measures: Waist circumference
Description
Waist circumference will be measured using inches.
Time Frame
Baseline
Title
Anthropometric Measures: Waist circumference
Description
Waist circumference will be measured using inches.
Time Frame
17 weeks
Title
Anthropometric Measures: Waist circumference
Description
Waist circumference will be measured using inches.
Time Frame
34 Weeks
Title
Total Body Composition
Description
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.
Time Frame
Baseline
Title
Total Body Composition
Description
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.
Time Frame
17 weeks
Title
Total Body Composition
Description
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.
Time Frame
34 Weeks
Title
Detailed body composition
Description
The investigators will perform MRI to assess adipose distribution in the abdomen and thigh
Time Frame
Baseline
Title
Detailed body composition
Description
The investigators will perform MRI to assess adipose distribution in the abdomen and thigh
Time Frame
34 Weeks
Title
Neuroinflammation
Description
The investigators will perform diffusion basis spectrum imaging (DBSI) MRI to assess neuroinflammation at WUSTL only
Time Frame
Baseline
Title
Neuroinflammation
Description
The investigators will perform DBSI MRI to assess neuroinflammation at WUSTL only
Time Frame
34 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brooks C Wingo, PhD
Phone
(205) 934-5982
Email
bcwingo@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn Green, BS
Phone
205-319-1424
Email
kathryngreen@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks Wingo, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooks C Wingo, PhD
Phone
205-934-5982
Email
bcwingo@uab.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Green, BS
Email
kathryngreen@uabmc.edu
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Piccio, MD, PhD
Email
picciol@wustl.edu
First Name & Middle Initial & Last Name & Degree
Courtney Dula
Email
dulac@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Functional Outcomes From Diets in Multiple Sclerosis

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