Trial Outcomes & Findings for Time Restricted Eating Outcomes in Multiple Sclerosis (NCT NCT04389970)
NCT ID: NCT04389970
Last Updated: 2024-03-27
Results Overview
Change in timed 25-foot walk test speed between baseline and 8 weeks. Speed calculated as ft per second, and change calculated as speed at baseline - speed at 8 weeks. Higher score indicates better outcome. There are no minimum or maximum values, as this is the measure of the time it takes a participant to walk 25 feet. Higher score indicates higher speed, which is preferable.
COMPLETED
NA
12 participants
Change from baseline to 8 weeks
2024-03-27
Participant Flow
Participant milestones
| Measure |
Time Restricted Feeding
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Time Restricted Feeding
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Time Restricted Eating Outcomes in Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Time Restricted Feeding
n=12 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Only study completers were included in the analysis.
Change in timed 25-foot walk test speed between baseline and 8 weeks. Speed calculated as ft per second, and change calculated as speed at baseline - speed at 8 weeks. Higher score indicates better outcome. There are no minimum or maximum values, as this is the measure of the time it takes a participant to walk 25 feet. Higher score indicates higher speed, which is preferable.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Timed 25-foot Walk Speed
|
-.3 feet/second
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
15-item questionnaire requiring respondent to rate types of pain as mild, moderate or severe. Scores range from 0-45, with higher pain intensity indicated by higher score. Change calculated as SFMPQ score at basline - SFMPQ score at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Short Form McGill Pain Questionnaire
|
-1.9 score on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
21-item questionnaire with possible score ranging from 0-84. Higher scores indicate higher impact of fatigue on a person's life. Change in MFIS was calculated as MFIS score at baseline - MFIS score at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Modified Fatigue Impact Scale
|
-1.3 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
9-item questionnaire in respondents rate each statement from strongly disagree to strongly agree. Total scores range from 9- 63, with higher score indicating higher fatigue severity. Change in FSS calculated as FSS at baseline - FSS at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Fatigue Severity Scale
|
2.3 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
19 self-rated items that produce 7 component scores and 1 global score. Only global scores were calculated for this study. Global scores can range from 0-21, with higher scores indicating poorer sleep quality. Change in PSQI calculated as PSQI at baseline - PSQI at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Pittsburgh Sleep Quality Index
|
.2 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Percent Lean Mass
|
0 percentage of total mass
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
Higher score indicates better outcome. Speed on 9 hole peg test was measured as pegs per second, and change in speed was calculated as speed at baseline - speed at 8 weeks. There are no minimum or maximum values, as the measure is time that it takes a person to complete the test. Higher score indicates faster speed, which is preferable.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
9 Hole Peg Test Speed
|
.02 pegs/second
Standard Deviation .03
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
The score is the number of symbols identified correctly in 90 seconds. Potential scores range from 0-110. Higher score indicate improved outcome. Change in score on the SDMT calculated as SDMT score at baseline- SDMT score at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Symbol Digit Modalities Test (SDMT)
|
5.8 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: Completers only
Change in fat mass as percentage of total body mass, measured by DXA. Calculated as percent fat mass at baseline- percent fat mass at 8 weeks.
Outcome measures
| Measure |
Time Restricted Feeding
n=11 Participants
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Time Restricted Feeding: Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
|
|---|---|
|
Percent Fat Mass
|
0 percentage of total mass
Standard Deviation 1.0
|
Adverse Events
Time Restricted Feeding
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place