Time Restricted Eating Outcomes in Multiple Sclerosis

NCT ID: NCT04389970

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-07-30

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.

Conditions

Multiple Sclerosis; Diet, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Time Restricted Feeding

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

Group Type: EXPERIMENTAL

Time Restricted Feeding

Intervention Type: BEHAVIORAL

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.

Interventions

Time Restricted Feeding

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Brooks C. Wingo, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brooks C Wingo, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36712417 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P30DK056336

Identifier Type: NIH

Identifier Source: secondary_id

View Link

300005334-001

Identifier Type: -

Identifier Source: org_study_id