Trial Outcomes & Findings for Time to Eat Study - Pilot (NCT NCT03590847)

NCT ID: NCT03590847

Last Updated: 2024-12-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: Week 4
• Results posted on: 2024-12-06

Participant Flow

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.

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.

Participant milestones

Measure	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.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Time to Eat Study - Pilot

Baseline characteristics by cohort

Measure	Intermittent Fasting n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	77.1 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Body Weight	96.96 kg STANDARD_DEVIATION 16.2 • n=5 Participants
Body Mass Index (BMI)	34.1 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants
Waist Circumference	109.43 cm STANDARD_DEVIATION 12.9 • n=5 Participants
Blood Glucose	105.6 mg/dL STANDARD_DEVIATION 28.2 • n=5 Participants
Systolic Blood Pressure	145.9 mmHg STANDARD_DEVIATION 15.6 • n=5 Participants
Diastolic Blood Pressure	78.1 mmHg STANDARD_DEVIATION 12.4 • n=5 Participants
Six Minute Walk Test (meters)	301.8 meters STANDARD_DEVIATION 91.0 • n=5 Participants
Six Minute Walk Test (m/s)	0.88 m/s STANDARD_DEVIATION 0.2 • n=5 Participants
Grip Strength	22.3 kg STANDARD_DEVIATION 7.0 • n=5 Participants
12-Item Short Form Survey Physical Function	13.6 units on a scale n=5 Participants
12-Item Short Form Survey Mental Function	22.0 score on a scale (0-100) n=5 Participants
12-Item Short Form Survey Total Score	35.6 score on a scale (0-100) n=5 Participants
Fatigability (Mental)	13.8 score on a scale (0-50) n=5 Participants
Fatigability (Physical)	24.7 score on a scale (0-50) n=5 Participants
Cognitive Function	25.6 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=10 Participants 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.

Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability

3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=10 Participants 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.

Adherence

84 percentage of days adherent Interval 50.0 to 100.0

PRIMARY outcome

Timeframe: Week 4

Number of Participants who dropped out before the Week 4 clinic visit was completed.

Outcome measures

Measure

Intermittent Fasting n=10 Participants 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.

Retention

1 Participants

PRIMARY outcome

Timeframe: Baseline

Recruitment yields is measured by the number of individuals who were assessed at phone screening.

Outcome measures

Measure

Intermittent Fasting n=10 Participants 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.

Recruitment Yields

65 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Body Weight

94.81 kg Standard Deviation 16.9

SECONDARY outcome

Timeframe: Week 4

Measure of body fat using weight from previous weight measurement.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Body Mass Index (BMI)

33.2 kg/m^2 Standard Deviation 3.2

SECONDARY outcome

Timeframe: Week 4

Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Waist Circumference

109.23 cm Standard Deviation 12.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Blood Glucose

107.3 mg/dL Standard Deviation 29.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Systolic Blood Pressure

148.22 mmHg Standard Deviation 24.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Diastolic Blood Pressure

78.89 mmHg Standard Deviation 8.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

6 Minute Walk Test (Meters)

310.89 meters Standard Deviation 111.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

6 Minute Walk Test (m/s)

0.92 m/s Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Grip Strength (Dominant Hand)

24.0 kg Standard Deviation 6.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

12-Item Short Form Survey Physical Function (Summary Score)

14.9 score on a scale (0-100) Interval 12.0 to 18.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

12-Item Short Form Survey Mental Function (Summary Score)

22.8 score on a scale (0-100) Interval 20.0 to 25.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

12-Item Short Form Survey Total Score

37.7 score on a scale (0-100) Interval 34.0 to 42.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Fatigability Questionnaire (Mental Subscale)

14.7 score on a scale (0-50) Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Fatigability Questionnaire (Physical Subscale)

24.9 score on a scale Interval 10.0 to 35.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

Intermittent Fasting n=9 Participants 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.

Montreal Cognitive Assessment

25.9 score on a scale Interval 20.0 to 29.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intermittent Fasting n=9 Participants 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.
Circulating (Plasma) microRNA Differentially expressed miRNA (upregulated)	6 Number of Differentially Expressed miRNA
Circulating (Plasma) microRNA Differentially expressed miRNA (total)	14 Number of Differentially Expressed miRNA
Circulating (Plasma) microRNA Differentially expressed miRNA (downregulated)	8 Number of Differentially Expressed miRNA

Adverse Events

Intermittent Fasting

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intermittent Fasting n=10 participants at risk 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.
Nervous system disorders Headache	20.0% 2/10 • Baseline to Week 4
Ear and labyrinth disorders Dizziness	10.0% 1/10 • Baseline to Week 4

Additional Information

Dr. Stephen Anton

University of Florida

Phone: (352) 273-7514

Email: santon@ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place