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The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.
For this 4-week pilot study, the study team will recruit 10 overweight, older adults who are at risk for, or have, mobility impairment, as measured by slow gait speed and self-reported mobility difficulty and self-reported sedentary lifestyle. All participants will receive the time restricted feeding intervention, which will consist of limiting the time in which food is consumed to 8 hours per day and fasting for 16 hours per day. The study will also assess the variance of inflammatory markers, walking speed, physical and cognitive function, grip strength, body measurements, perceived fatigability, health related quality of life and activity level. This allows the refinement of the design, recruitment yields, target population, adherence, retention, and tolerability of a larger scale study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent fasting | Experimental | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Fasting | Behavioral | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability | At each follow-up contact (either by phone or in person), participants are asked about any changes to their health or physical function since the previous contact. The changes are documented on the adverse event log. | Week 4 |
| Adherence | Adherence to the study intervention is measured using food intake time diary. Participants are considered compliant to the study intervention if he/she fasts between 14 - 18 hours per day for the duration of the 4 week study. | Week 4 |
| Retention | Number of Participants who dropped out before the Week 4 clinic visit was completed. | Week 4 |
| Recruitment Yields | Recruitment yields is measured by the number of individuals who were assessed at phone screening. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight will be measured following the removal of excess clothing and shoes with calibrated scales. Primary study outcomes include final weight at the 4 week assessment visit. | Week 4 |
| Body Mass Index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
Current dietary habits
Medical history or conditions
Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
Any condition that in the opinion of the investigator would impair ability to participate in the trial
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Anton, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Institute on Aging | Gainesville | Florida | 32610 | United States |
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Participants were overweight, sedentary older adults (≥65 years) with mild to moderate functional limitations. Participants were excluded from the study if they were unwilling to consent or had underlying health conditions that would cause personal risk as a result of participating. A telephone screening to ensure eligibility and review protocol for obtained consent. Baseline measurements and blood samples were collected to further determine eligibility.
Participants were recruited from the general population in the North/Central Florida area through mailing, advertisements, and targeted outreach to individuals who have consented to participation in the Claude D. Pepper Recruitment Registry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intermittent Fasting | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Intermittent Fasting: Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Overweight, sedentary older adults (≥65 years) with mild to moderate functional limitations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermittent Fasting | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Intermittent Fasting: Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability | At each follow-up contact (either by phone or in person), participants are asked about any changes to their health or physical function since the previous contact. The changes are documented on the adverse event log. | Posted | Count of Participants | Participants | No | Week 4 |
|
Baseline to Week 4
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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 | Intermittent Fasting | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Intermittent Fasting: Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment | Participants reported headaches during fasting periods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Anton | University of Florida | (352) 273-7514 | santon@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2018 | May 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2018 | May 30, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D000093763 | Intermittent Fasting |
| D007249 | Inflammation |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
|
Measure of body fat using weight from previous weight measurement.
| Week 4 |
| Waist Circumference | Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone. | Week 4 |
| Blood Glucose | Blood was drawn at a fasted state. Glucose levels were measured by Quest Diagnostic Clinical Laboratories, which is accredited by the College of American Pathologists. | Week 4 |
| Systolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Week 4 |
| Diastolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Week 4 |
| 6 Minute Walk Test (Meters) | The 6-Minute Walk Test (6MWT) measures the distance a participant can walk on a standard course within six minutes, without running or overexerting themselves. Contraindications for test administration and stopping rules will be followed according to the guidelines of the American Thoracic Society. The outcome will be reported in meters (m), representing the total distance covered during the 6-minute walk. | Week 4 |
| 6 Minute Walk Test (m/s) | The 6 Minute Walk test measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Contraindications for test administration and stopping rules based on American Thoracic Society will be followed. Walking speed was calculated by dividing number of meters walked by total time completed (360 seconds/6 minutes). | Week 4 |
| Grip Strength (Dominant Hand) | Isometric hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of functional status.Total force output is reported in kilograms (kg). | Week 4 |
| 12-Item Short Form Survey Physical Function (Summary Score) | Self-administered, 12-item questionnaire to measure health-related quality of life. Short form (SF) physical health status with scores on this measure ranging from 0 to 100, where greater scores represent better health. | Week 4 |
| 12-Item Short Form Survey Mental Function (Summary Score) | Self-administered, 12-item questionnaire to measure health-related quality of life. Short form (SF) mental health status with scores on this measure ranging from 0 to 100, where greater scores represent better health. | Week 4 |
| 12-Item Short Form Survey Total Score | A self-administered, 12-item questionnaire is used to measure health-related quality of life, specifically the Short Form (SF) general health perception. Scores range from 0 to 100, with higher scores indicating better perceived health. Total scores are reported. | Week 4 |
| Fatigability Questionnaire (Mental Subscale) | A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Week 4 |
| Fatigability Questionnaire (Physical Subscale) | A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Week 4 |
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) is a 30-point tool designed to assess mild cognitive impairment. It evaluates various cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is obtained by summing the individual subscores, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better cognitive function. To minimize learning effects from repeated administrations, different versions of the test were used at baseline and week four. | Week 4 |
| Circulating (Plasma) microRNA | The fold change in circulatory microRNA post-TRE regimen will be measured using the HTG EdgeSeq miRNA Whole Transcriptome Assay, which profiles the expression of circulatory miRNAs. The total number of differentially expressed miRNAs will be analyzed, including a breakdown of how many were differentially upregulated and downregulated. | Week 4 |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Weight | Measured following the removal of excess clothing and shoes with a calibrated scale (Detecto). | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Taken at the mid-point between the participant's lowest rib and the top of his/her hip bone. | Mean | Standard Deviation | cm |
|
| Blood Glucose | Blood was drawn at a fasted state. Glucose levels were measured by Quest Diagnostic Clinical Laboratories, which is accredited by the College of American Pathologists. | Mean | Standard Deviation | mg/dL |
|
| Systolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Mean | Standard Deviation | mmHg |
|
| Six Minute Walk Test (meters) | Measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Participants were instructed to walk at a fast pace and the distance covered in meters was measured. | Mean | Standard Deviation | meters |
|
| Six Minute Walk Test (m/s) | Measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Participants were instructed to walk at a fast pace and the distance covered in meters was measured. | Mean | Standard Deviation | m/s |
|
| Grip Strength | Participants were asked to squeeze the dynamometer as hard as possible with their dominant hand. Two measurements were taken, and the average was used in analyses. Isometric hand grip strength is a commonly used measure of upper body skeletal muscle function and is widely used as a general indicator of functional status. | Mean | Standard Deviation | kg |
|
| 12-Item Short Form Survey Physical Function | Summary score of the short-form physical health status from the 12-item health questionnaire, used to assess several domains of health related quality of life (HQRoL). Scores on this measure ranging from 0 to 100, with greater scores representing better health. | Mean | Full Range | units on a scale |
|
| 12-Item Short Form Survey Mental Function | Summary score of the short form mental health status from the 12-item health questionnaire, used to assess several domains of health related quality of life (HQRoL). Scores on this measure ranging from 0 to 100, with greater scores representing better health. | Mean | Full Range | score on a scale (0-100) |
|
| 12-Item Short Form Survey Total Score | Overall short form general health perception from the 12-item health questionnaire, used to assess several domains of health related quality of life (HQRoL). Scores on this measure ranging from 0 to 100, with greater scores representing better health. | Mean | Full Range | score on a scale (0-100) |
|
| Fatigability (Mental) | The Pittsburgh Fatigability Scale is a 26-item self-administered questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Mean | Full Range | score on a scale (0-50) |
|
| Fatigability (Physical) | The Pittsburgh Fatigability Scale is a 26-item self-administered questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Mean | Full Range | score on a scale (0-50) |
|
| Cognitive Function | The Montreal Cognitive Assessment (MoCA) is a 30-point tool designed to assess mild cognitive impairment. It evaluates various cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is obtained by summing the individual subscores, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better cognitive function. To minimize learning effects from repeated administrations, different versions of the test were used at baseline and week four. | Mean | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Adherence | Adherence to the study intervention is measured using food intake time diary. Participants are considered compliant to the study intervention if he/she fasts between 14 - 18 hours per day for the duration of the 4 week study. | Posted | Mean | Full Range | percentage of days adherent | Week 4 |
|
|
|
| Primary | Retention | Number of Participants who dropped out before the Week 4 clinic visit was completed. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Primary | Recruitment Yields | Recruitment yields is measured by the number of individuals who were assessed at phone screening. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Body Weight | Body weight will be measured following the removal of excess clothing and shoes with calibrated scales. Primary study outcomes include final weight at the 4 week assessment visit. | Posted | Mean | Standard Deviation | kg | Week 4 |
|
|
|
| Secondary | Body Mass Index (BMI) | Measure of body fat using weight from previous weight measurement. | Posted | Mean | Standard Deviation | kg/m^2 | Week 4 |
|
|
|
| Secondary | Waist Circumference | Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone. | Posted | Mean | Standard Deviation | cm | Week 4 |
|
|
|
| Secondary | Blood Glucose | Blood was drawn at a fasted state. Glucose levels were measured by Quest Diagnostic Clinical Laboratories, which is accredited by the College of American Pathologists. | Posted | Mean | Standard Deviation | mg/dL | Week 4 |
|
|
|
| Secondary | Systolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Posted | Mean | Standard Deviation | mmHg | Week 4 |
|
|
|
| Secondary | Diastolic Blood Pressure | Resting blood pressure was taken after participants spent 5 min seated in a quiet room, free of distractions. Blood pressure was obtained according to standardized protocol. Three readings of blood pressure, spaced one minute apart, were taken using a sphygmomanometer with appropriate cuff size. First reading was discarded and last two readings were averaged. If large differences were observed between second and third readings, an additional reading was taken and the median value of the three trials was used. | Posted | Mean | Standard Deviation | mmHg | Week 4 |
|
|
|
| Secondary | 6 Minute Walk Test (Meters) | The 6-Minute Walk Test (6MWT) measures the distance a participant can walk on a standard course within six minutes, without running or overexerting themselves. Contraindications for test administration and stopping rules will be followed according to the guidelines of the American Thoracic Society. The outcome will be reported in meters (m), representing the total distance covered during the 6-minute walk. | Posted | Mean | Standard Deviation | meters | Week 4 |
|
|
|
| Secondary | 6 Minute Walk Test (m/s) | The 6 Minute Walk test measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Contraindications for test administration and stopping rules based on American Thoracic Society will be followed. Walking speed was calculated by dividing number of meters walked by total time completed (360 seconds/6 minutes). | Posted | Mean | Standard Deviation | m/s | Week 4 |
|
|
|
| Secondary | Grip Strength (Dominant Hand) | Isometric hand grip strength is a commonly used measure of upper body skeletal muscle function and has been widely used as a general indicator of functional status.Total force output is reported in kilograms (kg). | Posted | Mean | Standard Deviation | kg | Week 4 |
|
|
|
| Secondary | 12-Item Short Form Survey Physical Function (Summary Score) | Self-administered, 12-item questionnaire to measure health-related quality of life. Short form (SF) physical health status with scores on this measure ranging from 0 to 100, where greater scores represent better health. | Posted | Mean | Full Range | score on a scale (0-100) | Week 4 |
|
|
|
| Secondary | 12-Item Short Form Survey Mental Function (Summary Score) | Self-administered, 12-item questionnaire to measure health-related quality of life. Short form (SF) mental health status with scores on this measure ranging from 0 to 100, where greater scores represent better health. | Posted | Mean | Full Range | score on a scale (0-100) | Week 4 |
|
|
|
| Secondary | 12-Item Short Form Survey Total Score | A self-administered, 12-item questionnaire is used to measure health-related quality of life, specifically the Short Form (SF) general health perception. Scores range from 0 to 100, with higher scores indicating better perceived health. Total scores are reported. | Posted | Mean | Full Range | score on a scale (0-100) | Week 4 |
|
|
|
| Secondary | Fatigability Questionnaire (Mental Subscale) | A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Posted | Mean | Full Range | score on a scale (0-50) | Week 4 |
|
|
|
| Secondary | Fatigability Questionnaire (Physical Subscale) | A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability. Scores range from 0-50 on a scale where higher scores represent higher levels of fatigability. | Posted | Mean | Full Range | score on a scale | Week 4 |
|
|
|
| Secondary | Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) is a 30-point tool designed to assess mild cognitive impairment. It evaluates various cognitive domains, including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is obtained by summing the individual subscores, with a minimum score of 0 and a maximum score of 30. Higher scores indicate better cognitive function. To minimize learning effects from repeated administrations, different versions of the test were used at baseline and week four. | Posted | Mean | Full Range | score on a scale | Week 4 |
|
|
|
| Secondary | Circulating (Plasma) microRNA | The fold change in circulatory microRNA post-TRE regimen will be measured using the HTG EdgeSeq miRNA Whole Transcriptome Assay, which profiles the expression of circulatory miRNAs. The total number of differentially expressed miRNAs will be analyzed, including a breakdown of how many were differentially upregulated and downregulated. | Posted | Number | Number of Differentially Expressed miRNA | Week 4 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D001522 | Behavior, Animal |
| Title | Measurements |
|---|---|
|