An interventional study of Time Restricted Feeding in Multiple Sclerosis and Diet, Healthy, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 12 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
Participants will be asked to follow a time-restricted meal pattern (8:16 protocol)
Behavioral: 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.
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.
Time frame: Change from baseline to 8 weeks
Short Form McGill Pain Questionnaire
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.
Time frame: Change from baseline to 8 weeks
Modified Fatigue Impact Scale
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.
Time frame: Change from baseline to 8 weeks
Fatigue Severity Scale
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.
Time frame: Change from baseline to 8 weeks
Pittsburgh Sleep Quality Index
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.
Time frame: Change from baseline to 8 weeks
Percent Lean Mass
Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA)
Time frame: Change from baseline to 8 weeks
9 Hole Peg Test Speed
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.
Time frame: Change from baseline to 8 weeks
Symbol Digit Modalities Test (SDMT)
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.
Time frame: Change from baseline to 8 weeks
Percent Fat Mass
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.
Time frame: Change from baseline to 8 weeks
| Milestone | Time Restricted Feeding |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| feet/second | Time Restricted Feeding |
|---|---|
| Timed 25-foot Walk Speed | -.3 ± 1.2 |
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.
| score on a scale | Time Restricted Feeding |
|---|---|
| Short Form McGill Pain Questionnaire | -1.9 ± 5.4 |
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.
| score on a scale | Time Restricted Feeding |
|---|---|
| Modified Fatigue Impact Scale | -1.3 ± 14.3 |
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.
| score on a scale | Time Restricted Feeding |
|---|---|
| Fatigue Severity Scale | 2.3 ± 16.7 |
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.
| score on a scale | Time Restricted Feeding |
|---|---|
| Pittsburgh Sleep Quality Index | .2 ± 4.0 |
Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA)
| percentage of total mass | Time Restricted Feeding |
|---|---|
| Percent Lean Mass | 0 ± 1.0 |
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.
| pegs/second | Time Restricted Feeding |
|---|---|
| 9 Hole Peg Test Speed | .02 ± .03 |
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.
| score on a scale | Time Restricted Feeding |
|---|---|
| Symbol Digit Modalities Test (SDMT) | 5.8 ± 8.3 |
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.
| percentage of total mass | Time Restricted Feeding |
|---|---|
| Percent Fat Mass | 0 ± 1.0 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Time Restricted Feeding | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Time Restricted Feeding |
|---|---|
| Mean | 46 ± 10 |
| Sex: Female, Male(Participants) | Time Restricted Feeding |
|---|---|
| Female | 10 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Time Restricted Feeding |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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University of Alabama at Birmingham