An interventional study of Intermittent Fasting in Overweight, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's enrollment of 10 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Current dietary habits
Medical history or conditions
Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks.
Behavioral: 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.
Also known as: Time Restricted Feeding
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.
Time frame: 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.
Time frame: Week 4
Retention
Number of Participants who dropped out before the Week 4 clinic visit was completed.
Time frame: Week 4
Recruitment Yields
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
Time frame: Baseline
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.
Time frame: Week 4
Body Mass Index (BMI)
Measure of body fat using weight from previous weight measurement.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4
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.
| Milestone | Intermittent Fasting |
|---|---|
| Started | 10 |
| Completed | 9 |
| Not completed | 1 |
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.
| Participants | Intermittent Fasting |
|---|---|
| Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability | 3 |
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.
| percentage of days adherent | Intermittent Fasting |
|---|---|
| Adherence | 84 (50 to 100) |
Number of Participants who dropped out before the Week 4 clinic visit was completed.
| Participants | Intermittent Fasting |
|---|---|
| Retention | 1 |
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
| participants | Intermittent Fasting |
|---|---|
| Recruitment Yields | 65 |
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.
| kg | Intermittent Fasting |
|---|---|
| Body Weight | 94.81 ± 16.9 |
Measure of body fat using weight from previous weight measurement.
| kg/m^2 | Intermittent Fasting |
|---|---|
| Body Mass Index (BMI) | 33.2 ± 3.2 |
Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
| cm | Intermittent Fasting |
|---|---|
| Waist Circumference | 109.23 ± 12.3 |
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.
| mg/dL | Intermittent Fasting |
|---|---|
| Blood Glucose | 107.3 ± 29.4 |
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.
| mmHg | Intermittent Fasting |
|---|---|
| Systolic Blood Pressure | 148.22 ± 24.2 |
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.
| mmHg | Intermittent Fasting |
|---|---|
| Diastolic Blood Pressure | 78.89 ± 8.3 |
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.
| meters | Intermittent Fasting |
|---|---|
| 6 Minute Walk Test (Meters) | 310.89 ± 111.2 |
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).
| m/s | Intermittent Fasting |
|---|---|
| 6 Minute Walk Test (m/s) | 0.92 ± 0.2 |
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).
| kg | Intermittent Fasting |
|---|---|
| Grip Strength (Dominant Hand) | 24.0 ± 6.8 |
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.
| score on a scale (0-100) | Intermittent Fasting |
|---|---|
| 12-Item Short Form Survey Physical Function (Summary Score) | 14.9 (12 to 18) |
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.
| score on a scale (0-100) | Intermittent Fasting |
|---|---|
| 12-Item Short Form Survey Mental Function (Summary Score) | 22.8 (20 to 25) |
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.
| score on a scale (0-100) | Intermittent Fasting |
|---|---|
| 12-Item Short Form Survey Total Score | 37.7 (34 to 42) |
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.
| score on a scale (0-50) | Intermittent Fasting |
|---|---|
| Fatigability Questionnaire (Mental Subscale) | 14.7 (0 to 28) |
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.
| score on a scale | Intermittent Fasting |
|---|---|
| Fatigability Questionnaire (Physical Subscale) | 24.9 (10 to 35) |
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.
| score on a scale | Intermittent Fasting |
|---|---|
| Montreal Cognitive Assessment | 25.9 (20 to 29) |
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.
| Number of Differentially Expressed miRNA | Intermittent Fasting |
|---|---|
| Differentially expressed miRNA (total) | 14 |
| Differentially expressed miRNA (downregulated) | 8 |
| Differentially expressed miRNA (upregulated) | 6 |
Collected over Baseline to Week 4. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intermittent Fasting | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Event | Intermittent Fasting |
|---|---|
| HeadacheNervous system disorders | 2/10 |
| DizzinessEar and labyrinth disorders | 1/10 |
Overweight, sedentary older adults (≥65 years) with mild to moderate functional limitations.
| Age, Categorical(Participants) | Intermittent Fasting |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 0 |
| >=65 years | 10 |
| Age, Continuous(years) | Intermittent Fasting |
|---|---|
| Mean | 77.1 (65 to 85) |
| Sex: Female, Male(Participants) | Intermittent Fasting |
|---|---|
| Female | 6 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | Intermittent Fasting |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Intermittent Fasting |
|---|---|
| United States | 10 |
| Body Weight(kg) | Intermittent Fasting |
|---|---|
| Mean | 96.96 ± 16.2 |
| Body Mass Index (BMI)(kg/m^2) | Intermittent Fasting |
|---|---|
| Mean | 34.1 ± 3.3 |
| Waist Circumference(cm) | Intermittent Fasting |
|---|---|
| Mean | 109.43 ± 12.9 |
12 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Jun 2018 to primary completion in Sep 2018, 2 months.
Results were first posted in Dec 2024, 6 years 3 months after primary completion.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 2 months is below that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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