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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK056336 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time Restricted Feeding | Experimental | Participants will be asked to follow a time-restricted meal pattern (8:16 protocol) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time Restricted Feeding | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brooks C Wingo, PhD | Univeristy of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36712417 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Time Restricted Feeding | Participants will be asked to follow a time-restricted meal pattern (8:16 protocol) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Time Restricted Feeding | Participants will be asked to follow a time-restricted meal pattern (8:16 protocol) 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only study completers were included in the analysis. | Posted | Mean | Standard Deviation | feet/second | Change from baseline to 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Time Restricted Feeding | Participants will be asked to follow a time-restricted meal pattern (8:16 protocol) 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brooks Wingo | University of Alabama at Birmingham | 2059345982 | bcwingo@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 20, 2020 | Mar 25, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
| 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. | 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. | 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) | 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. | 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. | 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. | Change from baseline to 8 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 8 weeks |
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| Secondary | Percent Lean Mass | Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA) | Completers only | Posted | Mean | Standard Error | percentage of total mass | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | pegs/second | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 8 weeks |
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| Secondary | 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. | Completers only | Posted | Mean | Standard Deviation | percentage of total mass | Change from baseline to 8 weeks |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |