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Time Restricted Eating Outcomes in Multiple Sclerosis (TREO_MS)

Primary Purpose

Multiple Sclerosis, Diet, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time Restricted Feeding
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time Restricted Feeding

Arm Description

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

Outcomes

Primary Outcome Measures

Multiple Sclerosis Functional Composite Score (MSFC)
Scored as composite of three components: Timed 25-foot walk, 9 hole peg test, symbol digit modalities test

Secondary Outcome Measures

Short Form McGill Pain Questionnaire
15-item questionnaire requiring respondent to rate types of pain as mild, moderate or severe
Modified Fatigue Impact Scale
21-item questionnaire providing scores on 3 components: physical, cognitive and psychosocial
Fatigue Severity Scale
9-item questionnaire in respondents rate each statement from strongly disagree to strongly agree
Pittsburgh Sleep Quality Index
19 self-rated items that produce 7 component scores and 1 global score
Body composition
Dual energy x-ray absorptiometry (DXA)
Insulin
Blood pressure
Continuous glucose monitoring
24 hour glucose monitoring using subcutaneous monitor
Tumor Necrosis Factor Alpha (TNFa)
Interleukin 6 (IL-6)
Interleukin 17 (IL-17)

Full Information

First Posted
May 7, 2020
Last Updated
August 4, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04389970
Brief Title
Time Restricted Eating Outcomes in Multiple Sclerosis
Acronym
TREO_MS
Official Title
Time Restricted Eating Outcomes in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Multiple sclerosis (MS) is a chronic autoimmune disease characterized by demyelination and loss of axons in the central nervous system. Over the last decade there has been an influx of evidence demonstrating the impact of lifestyle risk factors on the progression of MS symptoms. Specifically, epidemiological studies report that poor diet is associated with increased risk of disability in adults with MS. Despite this evidence, little research has explored dietary interventions that may reduce symptom burden of MS. One dietary intervention that has shown particular promise in animal models of MS is intermittent fasting (IF), which is a dietary pattern characterized by cycles of eating and extended fasting. There are a number of protocols for IF, including time restricted feeding (TRF), in which all food is consumed during a limited window of time each day. Growing evidence demonstrates that IF reduces inflammation, improves immune function, and improves cardiometabolic risk in animal models of MS, however, little of this research has been translated into human trials. In addition to these physiological benefits, the investigators believe that TRF will provide a behavioral benefit, as it addresses barriers traditionally seen in dietary interventions by shifting the focus from restricting what participants eat, to focusing on meal timing. The purpose of this pilot study is to determine the preliminary efficacy, safety, and acceptability of TRF in adults with MS. 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. Twelve adults with relapsing-remitting MS will eat all meals within an 8 hour period each day. All participants will follow the assigned meal plan for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Diet, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Feeding
Arm Type
Experimental
Arm Description
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Intervention Type
Behavioral
Intervention Name(s)
Time Restricted Feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Multiple Sclerosis Functional Composite Score (MSFC)
Description
Scored as composite of three components: Timed 25-foot walk, 9 hole peg test, symbol digit modalities test
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Short Form McGill Pain Questionnaire
Description
15-item questionnaire requiring respondent to rate types of pain as mild, moderate or severe
Time Frame
Change from baseline to 8 weeks
Title
Modified Fatigue Impact Scale
Description
21-item questionnaire providing scores on 3 components: physical, cognitive and psychosocial
Time Frame
Change from baseline to 8 weeks
Title
Fatigue Severity Scale
Description
9-item questionnaire in respondents rate each statement from strongly disagree to strongly agree
Time Frame
Change from baseline to 8 weeks
Title
Pittsburgh Sleep Quality Index
Description
19 self-rated items that produce 7 component scores and 1 global score
Time Frame
Change from baseline to 8 weeks
Title
Body composition
Description
Dual energy x-ray absorptiometry (DXA)
Time Frame
Change from baseline to 8 weeks
Title
Insulin
Time Frame
Change from baseline to 8 weeks
Title
Blood pressure
Time Frame
Change from baseline to 8 weeks
Title
Continuous glucose monitoring
Description
24 hour glucose monitoring using subcutaneous monitor
Time Frame
Change from baseline to 8 weeks
Title
Tumor Necrosis Factor Alpha (TNFa)
Time Frame
Change from baseline to 8 weeks
Title
Interleukin 6 (IL-6)
Time Frame
Change from baseline to 8 weeks
Title
Interleukin 17 (IL-17)
Time Frame
Change from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks C Wingo, PhD
Organizational Affiliation
Univeristy of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Time Restricted Eating Outcomes in Multiple Sclerosis

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