Overweight
Conditions
Keywords
Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding
Brief summary
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.
Detailed description
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.
Interventions
BEHAVIORALIntermittent 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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Consent to participate in the study * Men and women ≥ 65 years old * Self-reported difficulty walking ¼ mile or climbing a flight of stairs * Self-reported sedentariness (\<30 minutes structured exercise per week) * Walking speed \<1 m/sec on the 4 m walk test * Able to walk unassisted (cane allowed) * Have a body mass index between 25 - 40 kg/m2 (inclusive)
Exclusion criteria
* Current dietary habits * Fasting \>12 hours per day * Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake * Weight loss \> 5 lbs in the past month * Medical history or conditions * Resting heart rate of \>120 beats per minute, systolic blood pressure \> 180 mmHg or diastolic blood pressure of \> 100 mmHg * Unstable angina, heart attack or stroke in the past 3 months * Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure * Rheumatoid arthritis, Parkinson's disease or currently on dialysis * Active treatment for cancer in the past year * Insulin dependent diabetes mellitus * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability | Week 4 | 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. |
| Adherence | Week 4 | 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. |
| Retention | Week 4 | Number of Participants who dropped out before the Week 4 clinic visit was completed. |
| Recruitment Yields | Baseline | Recruitment yields is measured by the number of individuals who were assessed at phone screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Week 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. |
| Diastolic Blood Pressure | Week 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. |
| 6 Minute Walk Test (Meters) | Week 4 | 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. |
| 6 Minute Walk Test (m/s) | Week 4 | 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). |
| Grip Strength (Dominant Hand) | Week 4 | 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). |
| 12-Item Short Form Survey Physical Function (Summary Score) | Week 4 | 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. |
| Body Weight | Week 4 | 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. |
| 12-Item Short Form Survey Total Score | Week 4 | 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. |
| Fatigability Questionnaire (Mental Subscale) | Week 4 | 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. |
| Fatigability Questionnaire (Physical Subscale) | Week 4 | 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. |
| Montreal Cognitive Assessment | Week 4 | 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. |
| Circulating (Plasma) microRNA | Week 4 | 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. |
| 12-Item Short Form Survey Mental Function (Summary Score) | Week 4 | 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. |
| Body Mass Index (BMI) | Week 4 | Measure of body fat using weight from previous weight measurement. |
| Waist Circumference | Week 4 | Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone. |
| Blood Glucose | Week 4 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Intermittent Fasting |
|---|---|
| 12-Item Short Form Survey Mental Function | 22.0 score on a scale (0-100) |
| 12-Item Short Form Survey Physical Function | 13.6 units on a scale |
| 12-Item Short Form Survey Total Score | 35.6 score on a scale (0-100) |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 77.1 years |
| Blood Glucose | 105.6 mg/dL STANDARD_DEVIATION 28.2 |
| Body Mass Index (BMI) | 34.1 kg/m^2 STANDARD_DEVIATION 3.3 |
| Body Weight | 96.96 kg STANDARD_DEVIATION 16.2 |
| Cognitive Function | 25.6 units on a scale |
| Diastolic Blood Pressure | 78.1 mmHg STANDARD_DEVIATION 12.4 |
| Fatigability (Mental) | 13.8 score on a scale (0-50) |
| Fatigability (Physical) | 24.7 score on a scale (0-50) |
| Grip Strength | 22.3 kg STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 10 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
| Six Minute Walk Test (meters) | 301.8 meters STANDARD_DEVIATION 91 |
| Six Minute Walk Test (m/s) | 0.88 m/s STANDARD_DEVIATION 0.2 |
| Systolic Blood Pressure | 145.9 mmHg STANDARD_DEVIATION 15.6 |
| Waist Circumference | 109.43 cm STANDARD_DEVIATION 12.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | Adherence | 84 percentage of days adherent |
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.
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intermittent Fasting | Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability | 3 Participants |
Primary
Recruitment Yields
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intermittent Fasting | Recruitment Yields | 65 participants |
Primary
Retention
Number of Participants who dropped out before the Week 4 clinic visit was completed.
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intermittent Fasting | Retention | 1 Participants |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | 12-Item Short Form Survey Mental Function (Summary Score) | 22.8 score on a scale (0-100) |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | 12-Item Short Form Survey Physical Function (Summary Score) | 14.9 score on a scale (0-100) |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | 12-Item Short Form Survey Total Score | 37.7 score on a scale (0-100) |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | 6 Minute Walk Test (Meters) | 310.89 meters | Standard Deviation 111.2 |
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).
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | 6 Minute Walk Test (m/s) | 0.92 m/s | Standard Deviation 0.2 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Blood Glucose | 107.3 mg/dL | Standard Deviation 29.4 |
Secondary
Body Mass Index (BMI)
Measure of body fat using weight from previous weight measurement.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Body Mass Index (BMI) | 33.2 kg/m^2 | Standard Deviation 3.2 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Body Weight | 94.81 kg | Standard Deviation 16.9 |
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.
Time frame: Week 4
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intermittent Fasting | Circulating (Plasma) microRNA | Differentially expressed miRNA (total) | 14 Number of Differentially Expressed miRNA |
| Intermittent Fasting | Circulating (Plasma) microRNA | Differentially expressed miRNA (downregulated) | 8 Number of Differentially Expressed miRNA |
| Intermittent Fasting | Circulating (Plasma) microRNA | Differentially expressed miRNA (upregulated) | 6 Number of Differentially Expressed miRNA |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Diastolic Blood Pressure | 78.89 mmHg | Standard Deviation 8.3 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | Fatigability Questionnaire (Mental Subscale) | 14.7 score on a scale (0-50) |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | Fatigability Questionnaire (Physical Subscale) | 24.9 score on a scale |
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).
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Grip Strength (Dominant Hand) | 24.0 kg | Standard Deviation 6.8 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intermittent Fasting | Montreal Cognitive Assessment | 25.9 score on a scale |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Systolic Blood Pressure | 148.22 mmHg | Standard Deviation 24.2 |
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.
Time frame: Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Fasting | Waist Circumference | 109.23 cm | Standard Deviation 12.3 |