Time to Eat Study - Pilot

December 2, 2024 updated by: University of Florida
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Institute on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intermittent fasting
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.
Other Names:
  • Time Restricted Feeding

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 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.
Week 4
Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability
Time Frame: 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.
Week 4
Retention
Time Frame: Week 4
Number of Participants who dropped out before the Week 4 clinic visit was completed.
Week 4
Recruitment Yields
Time Frame: Baseline
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Weight
Time Frame: 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.
Week 4
Body Mass Index (BMI)
Time Frame: Week 4
Measure of body fat using weight from previous weight measurement.
Week 4
Waist Circumference
Time Frame: Week 4
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
Time Frame: 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.
Week 4
Systolic Blood Pressure
Time Frame: 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.
Week 4
Diastolic Blood Pressure
Time Frame: 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.
Week 4
6 Minute Walk Test (Meters)
Time Frame: 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.
Week 4
6 Minute Walk Test (m/s)
Time Frame: 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).
Week 4
Grip Strength (Dominant Hand)
Time Frame: 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).
Week 4
12-Item Short Form Survey Physical Function (Summary Score)
Time Frame: 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.
Week 4
12-Item Short Form Survey Mental Function (Summary Score)
Time Frame: 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.
Week 4
12-Item Short Form Survey Total Score
Time Frame: 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.
Week 4
Fatigability Questionnaire (Mental Subscale)
Time Frame: 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.
Week 4
Fatigability Questionnaire (Physical Subscale)
Time Frame: 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.
Week 4
Montreal Cognitive Assessment
Time Frame: 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.
Week 4
Circulating (Plasma) microRNA
Time Frame: 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.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Anton, PhD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201801293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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