Time Restricted Eating Outcomes in Multiple Sclerosis
Time Restricted Eating Outcomes in Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Timed 25-foot Walk Speed | .39 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Time Restricted Feeding
Results by group
Timed 25-foot Walk Speed
Change from baseline to 8 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Time Restricted Feeding | -.3 feet/second | 1.2 (Standard Deviation) | 11 |
p = .39
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Time Restricted Feeding | 12 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Timed 25-foot Walk Speed
Change from baseline to 8 weeks
Disability progressionWalking and mobility
Other measures (8)
Short Form McGill Pain Questionnaire
Change from baseline to 8 weeks
PainModified Fatigue Impact Scale
Change from baseline to 8 weeks
FatigueFatigue Severity Scale
Change from baseline to 8 weeks
FatiguePittsburgh Sleep Quality Index
Change from baseline to 8 weeks
Mood and sleepPercent Lean Mass
Change from baseline to 8 weeks
9 Hole Peg Test Speed
Change from baseline to 8 weeks
Disability progressionSymbol Digit Modalities Test (SDMT)
Change from baseline to 8 weeks
Thinking and memoryPercent Fat Mass
Change from baseline to 8 weeks
Physical function
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Diagnosed with Relapsing Remitting MS (RRMS) * BMI between 18-50 kg.m2 * If on disease-modifying medications, stable for 6 months * If not on disease-modifying medication, no medication usage within previous 6 months * Able to walk 25 ft. with or without assistance
Exclusion criteria
* Relapse within previous 30 days * Actively engaged in a weight loss program or unwilling to follow assigned dietary timing pattern * Regularly fasts >15 hours/day * Pregnant or breastfeeding * Current use of insulin or sulfonylurea agents
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this pilot study is to determine the preliminary efficacy, safety, and acceptability of time restricted feeding (TRF) among a sample of 12 adults with Relapsing-Remitting Multiple Sclerosis (RRMS). The specific aims of this study are: 1: To determine preliminary efficacy of TRF for reducing symptom burden, improving inflammatory markers, and reducing cardiometabolic risk among adults with RRMS. 2: To determine the safety and participant acceptability of TRF. Participants will be asked to consume all food during an 8-hour window each day and not eat for the remaining 16 hours. All participants will follow this eating pattern for 8 weeks.
Papers
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History
Started
Oct 2020
Main results due
Jul 2021
Finished
Jul 2021
Results posted
Mar 2024