Diet, Healthy, Multiple Sclerosis
Conditions
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.
Interventions
BEHAVIORALTime 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed 25-foot Walk Speed | Change from baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Fatigue Impact Scale | Change from baseline to 8 weeks | 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. |
| Fatigue Severity Scale | Change from baseline to 8 weeks | 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. |
| Pittsburgh Sleep Quality Index | Change from baseline to 8 weeks | 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. |
| Short Form McGill Pain Questionnaire | Change from baseline to 8 weeks | 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. |
| 9 Hole Peg Test Speed | Change from baseline to 8 weeks | 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. |
| Symbol Digit Modalities Test (SDMT) | Change from baseline to 8 weeks | 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. |
| Percent Fat Mass | Change from baseline to 8 weeks | 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. |
| Percent Lean Mass | Change from baseline to 8 weeks | Lean mass as a percent of total body mass, measured by dual energy x-ray absorptiometry (DXA) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Time Restricted Feeding |
|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Change from baseline to 8 weeks
Population: Only study completers were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Timed 25-foot Walk Speed | -.3 feet/second | Standard Deviation 1.2 |
Comparison: This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.p-value: 0.39t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | 9 Hole Peg Test Speed | .02 pegs/second | Standard Deviation 0.03 |
Comparison: 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.p-value: 0.06t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Fatigue Severity Scale | 2.3 score on a scale | Standard Deviation 16.7 |
Comparison: 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.p-value: 0.66t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Modified Fatigue Impact Scale | -1.3 score on a scale | Standard Deviation 14.3 |
Comparison: 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.p-value: 0.77t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Percent Fat Mass | 0 percentage of total mass | Standard Deviation 1 |
Comparison: 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.p-value: 0t-test, 2 sided
Secondary
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
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Percent Lean Mass | 0 percentage of total mass | Standard Error 1 |
Comparison: 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.p-value: 0.03t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Pittsburgh Sleep Quality Index | .2 score on a scale | Standard Deviation 4 |
Comparison: 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.p-value: 0.88t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Short Form McGill Pain Questionnaire | -1.9 score on a scale | Standard Deviation 5.4 |
Comparison: 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.p-value: 0.3t-test, 2 sided
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.
Time frame: Change from baseline to 8 weeks
Population: Completers only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Symbol Digit Modalities Test (SDMT) | 5.8 score on a scale | Standard Deviation 8.3 |
Comparison: 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.p-value: 0.04t-test, 2 sided