NCT04389970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

May 7, 2020

Results QC Date

November 23, 2022

Last Update Submit

March 25, 2024

Conditions

Multiple SclerosisDiet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Timed 25-foot Walk Speed

    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.

    Change from baseline to 8 weeks

Secondary Outcomes (8)

  • Short Form McGill Pain Questionnaire

    Change from baseline to 8 weeks

  • Modified Fatigue Impact Scale

    Change from baseline to 8 weeks

  • Fatigue Severity Scale

    Change from baseline to 8 weeks

  • Pittsburgh Sleep Quality Index

    Change from baseline to 8 weeks

  • Percent Lean Mass

    Change from baseline to 8 weeks

  • +3 more secondary outcomes

Study Arms (1)

Time Restricted Feeding

EXPERIMENTAL

Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)

Behavioral: Time Restricted Feeding

Interventions

Time Restricted FeedingBEHAVIORAL

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.

Time Restricted Feeding

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Wingo BC, Rinker JR 2nd, Green K, Peterson CM. Feasibility and acceptability of time-restricted eating in a group of adults with multiple sclerosis. Front Neurol. 2023 Jan 12;13:1087126. doi: 10.3389/fneur.2022.1087126. eCollection 2022.

    PMID: 36712417DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.

Results Point of Contact

Title
Brooks Wingo
Organization
University of Alabama at Birmingham
bcwingo@uab.edu
2059345982

Study Officials

  • Brooks C Wingo, PhD

    Univeristy of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 15, 2020

Study Start

October 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

March 27, 2024

Results First Posted

March 27, 2024

Record last verified: 2024-03

Locations

US(1)