NCT04389970: TREO_MS

Time Restricted Eating Outcomes in Multiple Sclerosis

Completed NA Results posted Last updated 27 March 2024

What this trial tests

NA trial testing Time Restricted Feeding in Multiple Sclerosis in 12 participants. Completed in 30 July 2021.

Timeline

1 October 2020

Primary endpoint
30 July 2021

30 July 2021

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 October 2020
Primary completion	30 July 2021
Estimated completion	30 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Time Restricted Feeding

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Diet, Healthy — all drugs for Diet, Healthy →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis or Diet, Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Timed 25-foot Walk Speed Primary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	-.3	± 1.2

Short Form McGill Pain Questionnaire Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	-1.9	± 5.4

Modified Fatigue Impact Scale Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	-1.3	± 14.3

Fatigue Severity Scale Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	2.3	± 16.7

Pittsburgh Sleep Quality Index Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	.2	± 4.0

Percent Lean Mass Secondary · Change from baseline to 8 weeks

Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA)

Group	Value	95% CI
Time Restricted Feeding	0	± 1.0

9 Hole Peg Test Speed Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	.02	± .03

Symbol Digit Modalities Test (SDMT) Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	5.8	± 8.3

Percent Fat Mass Secondary · Change from baseline to 8 weeks

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.

Group	Value	95% CI
Time Restricted Feeding	0	± 1.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis.
   Wingo BC, Rinker JR, Green K, Peterson CM. · · 2022 · cited 17× · PMID 36712417 · DOI 10.3389/fneur.2022.1087126