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A Pragmatic Trial of Dietary Programs in People With Multiple Sclerosis (MS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846558
Recruitment Status : Completed
First Posted : July 27, 2016
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Other: Frequent Patient Interaction
Behavioral: Timing Restriction
Device: LoseIt! Smartphone Application
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Hide Arm/Group Description

MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Patients will receive initial training in using the app, and then receive weekly supportive messages encouraging them to adhere to the calorie restriction diet between 3- and 6-month followup visits. Results will be compared primarily to those collected from the Standard of Care arm.

Frequent Patient Interaction: Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.

LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

MS patients receiving monthly natalizumab infusions will use the LoseIt! smartphone application to log daily food consumption. Data from the app will be collected at follow-up visits. Besides initial training with the application and 3- and 6-month follow up exams, participants will not receive additional support or interaction from the study team.Results will be compared with those collected from the Frequent Patient Interaction arm.

LoseIt! Smartphone Application: Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.

MS patients receiving monthly natalizumab infusions who are ineligible for the calorie restriction portion of the study (the Frequent Patient Activation and Standard of Care arms) will be offered the option to enroll in the second part of the study, assessing differences in outcomes between daily 16-hour fasting periods and no dietary changes. Patients in the second part of the study randomized to this arm will consume their normal daily food intake, but restrict eating to an 8-hour period during the day. Results will be compared to patients who do not make any changes to their diet, the No Change arm.

Timing Restriction: Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.

MS patients receiving natalizumab infusions who were ineligible for the calorie restriction portion of the study (e.g. body mass index < 25 kg/m^2) or did not wish to participate in calorie restriction, may elect to be part of the second portion of the study. If so, they may be randomized to this arm, in which no changes are made to amount or timing of daily food intake. Results will be compared with the experimental Timing arm
Period Title: Overall Study
Started 15 12 14 13
Baseline Study Visit 10 9 14 12
3 Month Study Visit 7 8 12 11
Completed 7 8 12 11
Not Completed 8 4 2 2
Reason Not Completed
Adverse Event             1             0             0             0
Withdrawal by Subject             5             4             2             2
Lost to Follow-up             2             0             0             0
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change Total
Hide Arm/Group Description Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet. Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits. Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals. Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period. Total of all reporting groups
Overall Number of Baseline Participants 10 9 12 12 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
31.10  (6.00) 31.18  (3.79) 39.83  (10.94) 43.42  (11.77) 41.73  (11.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
Female
10
 100.0%
7
  77.8%
10
  83.3%
10
  83.3%
37
  86.0%
Male
0
   0.0%
2
  22.2%
2
  16.7%
2
  16.7%
6
  14.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
White
6
  60.0%
7
  77.8%
8
  66.7%
7
  58.3%
28
  65.1%
African American
3
  30.0%
0
   0.0%
4
  33.3%
4
  33.3%
11
  25.6%
Non-White Hispanic
1
  10.0%
1
  11.1%
0
   0.0%
0
   0.0%
2
   4.7%
Asian
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
   2.3%
Other
0
   0.0%
1
  11.1%
0
   0.0%
1
   8.3%
2
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
10 9 12 12 43
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
92.58  (17.26) 82.76  (16.89) 66.25  (8.12) 70.13  (16.06) 76.91  (17.73)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
30.04  (6.52) 30.22  (4.78) 24.28  (3.16) 25.86  (6.22) 28.00  (6.21)
Waist Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
110.22  (19.31) 102.16  (13.05) 87.58  (11.63) 89.38  (12.58) 96.4  (16.68)
Hip Circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
118.36  (14.85) 109.80  (7.15) 99.08  (7.24) 100.26  (11.01) 106.14  (12.84)
Patient-Determined Disability Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
1.09  (1.62) 1.89  (1.54) 2.58  (1.56) 3.00  (2.14) 2.21  (1.82)
[1]
Measure Description: The Patient-Determine Disability Scale (PDDS) measures level of disability from multiple sclerosis as reported by the patient. The scale ranges from a minimum of 0 (No disability - "I may have some mild symptoms, mostly sensory due to MS, but they do not limit my activity") to a maximum of 8 (Bedridden - "Unable to sit in a wheelchair for more than one hour"). Lower values on this scale indicate less disability from multiple sclerosis. A reduction in PDDS over the study period indicates a better outcome, or improvement in disability/symptoms from MS, among participants.
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue-MS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
21.40  (9.30) 22.94  (7.67) 22.50  (6.49) 20.96  (9.46) 21.91  (8.05)
[1]
Measure Description: The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue is a 95-item question bank to evaluate fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue specifically in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue; reduction in score over 6 months indicates a better outcome.
Pittsburgh Sleep Quality Index Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
8.50  (4.56) 6.56  (4.22) 7.75  (5.96) 8.17  (4.76) 7.79  (4.74)
[1]
Measure Description: The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates "poor" from "good" sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates "poor" quality sleep, while a score of 0-4 indicates "good" quality sleep; lower scores indicate better sleep quality.
Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
174.73  (38.05) 162.49  (34.24) 145.81  (36.48) 144.86  (49.44) 156.02  (40.72)
[1]
Measure Description: The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. It contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thinking/fatigue, and family/social wellbeing. Subscores are the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in score over the study period indicates a better outcome.
Rosenberg Self-Esteem Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 10 participants 9 participants 12 participants 12 participants 43 participants
21.65  (7.89) 25.11  (2.42) 24.33  (1.56) 24.17  (2.69) 23.83  (4.31)
[1]
Measure Description: The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Higher scores indicate higher/better self-esteem. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.
1.Primary Outcome
Title Adherence
Hide Description Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Hide Arm/Group Description:
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals.
Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
Overall Number of Participants Analyzed 10 9 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  20.0%
6
  66.7%
10
  83.3%
12
 100.0%
2.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description Change in body mass index from baseline to 6 months.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits.
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 7 8 12 11
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-0.83  (1.77) -1.03  (1.13) 0.04  (1.09) -0.22  (0.70)
3.Secondary Outcome
Title Weight Change
Hide Description Change in participant weight over the 6-month study period
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits.
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 7 8 12 11
Mean (Standard Deviation)
Unit of Measure: KG
-2.15  (4.72) -2.85  (3.06) 0.12  (3.02) -0.52  (1.88)
4.Secondary Outcome
Title Weight Change Among Adherent Participants
Hide Description The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Discrepancy in numbers is due to non-completers. 5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Adherent Participants Calorie Restriction - Non-Adherent Participants
Hide Arm/Group Description:
Participants still following a calorie restriction diet, continuous or intermittent, at the end of the 6 month period. Includes participants in both randomization arms (frequent communication and standard of care).
Participants who started in either the frequent communication or communication standard of care arms, following a calorie restriction diet, but who stopped the diet prior to the end of the 6-month study period.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: kg
-4.97  (4.06) -0.22  (2.38)
5.Secondary Outcome
Title Functional Assessment in MS Score
Hide Description The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits.
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 8 7 12 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.96  (28.38) 5.73  (18.62) 5.42  (21.71) 2.17  (23.90)
6.Secondary Outcome
Title Fatigue
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Discrepancy in numbers is due to non-completers
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 7 8 12 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-3.38  (3.96) -2.07  (4.60) -0.58  (5.35) 1.18  (5.42)
7.Secondary Outcome
Title Sleep Quality
Hide Description The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates "poor" from "good" sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates "poor" quality sleep, while a score of 0-4 indicates "good" quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits.
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 7 8 12 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.33  (3.08) -0.75  (2.19) -1.50  (3.78) -0.73  (3.95)
8.Secondary Outcome
Title Self-esteem
Hide Description The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of the initial 43 participants dropped out of the study voluntarily
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Time Restriction No Diet Change
Hide Arm/Group Description:
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages was sent to patients, encouraging adherence to the calorie restriction diet.
Participants selected to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants did not receive additional support or interaction from the study team apart from the scheduled study visits.
Participants adhering to a daily 16-hour fasting period, so they restrict all calorie intake to an 8-hour interval each day.
Participants make no changes to their normal diet.
Overall Number of Participants Analyzed 7 8 12 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.39  (2.06) -1.00  (1.93) -1.00  (2.70) 1.41  (3.53)
Time Frame Adverse event data was collected through the duration of the 6-month intervention period for each participant. Including all participants, this data was collected from October 2016 until the end of June 2017.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Hide Arm/Group Description Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet. Participants select to restrict calories continuously (25% daily) or intermittently (76% twice per week) for the 6-month study period. Participants will not receive additional support or interaction from the study team apart from the scheduled study visits. Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to time restriction. In this arm, participants restrict their calorie intake to an 8-hour interval each day, providing time for a 16-hour fast between intervals. Patients who do not qualify for, or do not wish to complete, the calorie restriction diet, may be randomized to not make any diet changes. This group is instructed to continue eating their normal diet throughout the 6-month study period.
All-Cause Mortality
Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/9 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Serious Adverse Events
Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/9 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calorie Restriction - Frequent Patient Communication Calorie Restriction - Communication Standard of Care Timing Restriction No Diet Change
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/9 (0.00%)      0/12 (0.00%)      0/12 (0.00%)    
Nervous system disorders         
Migraine * [1]  1/10 (10.00%)  1 0/9 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
One patient with a known history of migraine headaches experienced migraines on fasting days for the intermittent calorie restriction option, and self-discontinued the dietary intervention.
Limited sample size; Participants were enrolled from one treatment center, limited to patients with relapsing-remitting subtype of MS on natalizumab treatments; Calorie and timing data were self-reported by participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ellen Mowry, M.D., M.C.R.
Organization: Johns Hopkins Department of Neurology
Phone: 410-502-0675
EMail: emowry1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02846558    
Other Study ID Numbers: IRB00105123
First Submitted: July 20, 2016
First Posted: July 27, 2016
Results First Submitted: April 13, 2018
Results First Posted: June 15, 2018
Last Update Posted: June 15, 2018