N/A
Completed N=12
Time Restricted Eating Outcomes in Multiple Sclerosis
Multiple Sclerosis · Diet, Healthy
Source: ClinicalTrials.gov NCT04389970 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Timed 25-foot Walk Speed — -.3 feet/second — p=.39
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Timed 25-foot Walk Speed |
-.3 | .39 |
| SECONDARY Short Form McGill Pain Questionnaire |
-1.9 | .3 |
| SECONDARY Modified Fatigue Impact Scale |
-1.3 | .77 |
| SECONDARY Fatigue Severity Scale |
2.3 | .66 |
| SECONDARY Pittsburgh Sleep Quality Index |
.2 | .88 |
| SECONDARY Percent Lean Mass |
— | .03 sig |
| SECONDARY 9 Hole Peg Test Speed |
.02 | .06 |
| SECONDARY Symbol Digit Modalities Test (SDMT) |
5.8 | .04 sig |
| SECONDARY Percent Fat Mass |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04389970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.