Clinical trial NCT04389970: Time Restricted Eating Outcomes in Multiple Sclerosis
Official title: Time Restricted Eating Outcomes in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Diet, Healthy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-05-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timed 25-foot Walk Speed
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Short Form McGill Pain Questionnaire
timeFrame: Change from baseline to 8 weeks
measure: Modified Fatigue Impact Scale
timeFrame: Change from baseline to 8 weeks
measure: Fatigue Severity Scale
timeFrame: Change from baseline to 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline to 8 weeks
measure: Percent Lean Mass
timeFrame: Change from baseline to 8 weeks
measure: 9 Hole Peg Test Speed
timeFrame: Change from baseline to 8 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from baseline to 8 weeks
measure: Percent Fat Mass
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Univeristy of Alabama at Birmingham
name: Brooks C Wingo, PhD
role: PRINCIPAL_INVESTIGATOR
References: