OverweightNCT03590847
Time to Eat Study - Pilot
A study testing Intermittent Fasting in people with Overweight, run by University of Florida at 1 site in United States.
Trial summary
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 5 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Institute on Aging
Gainesville, Florida, 32610
About this study
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.
Read the 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.
- Conditions
- Overweight
- Being tested
- Intermittent Fasting
- Keywords
- Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding
- Medical subject headings
- Overweight, Intermittent Fasting, Inflammation, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent FastingBehavioural
Also called Time Restricted Feeding
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Receives: Behavioral: Intermittent Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4
Retention
Number of Participants who dropped out before the Week 4 clinic visit was completed.
Measured: Week 4
Recruitment Yields
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
Measured: Baseline
Secondary outcomes (16)
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.
Measured: Week 4
Body Mass Index (BMI)
Measure of body fat using weight from previous weight measurement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start28 Jun 2018
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Anton, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590847
- Sponsor's protocol ID
- IRB201801293
- Status last verified
- Dec 2024
- First submitted
- 8 Jun 2018
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Eat Study - Pilot
- ClinicalTrials.gov ID
- NCT03590847
- Acronym / sponsor ID
- IRB201801293
- Conditions
- Overweight
- Keywords
- Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Behavioral: Intermittent FastingStudy participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent FastingAlso: Time Restricted FeedingStudy 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. | Behavioural | Intermittent fasting |
Primary outcome
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.
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.
Retention
Time frame: Week 4
Number of Participants who dropped out before the Week 4 clinic visit was completed.
Recruitment Yields
Time frame: Baseline
Recruitment yields is measured by the number of individuals who were assessed at phone screening.
16 secondary outcomes
Body Weight
Time frame: Week 4
Body Mass Index (BMI)
Time frame: Week 4
Waist Circumference
Time frame: Week 4
Blood Glucose
Time frame: Week 4
Systolic Blood Pressure
Time frame: Week 4
Diastolic Blood Pressure
Time frame: Week 4
6 Minute Walk Test (Meters)
Time frame: Week 4
6 Minute Walk Test (m/s)
Time frame: Week 4
Grip Strength (Dominant Hand)
Time frame: Week 4
12-Item Short Form Survey Physical Function (Summary Score)
Time frame: Week 4
12-Item Short Form Survey Mental Function (Summary Score)
Time frame: Week 4
12-Item Short Form Survey Total Score
Time frame: Week 4
Fatigability Questionnaire (Mental Subscale)
Time frame: Week 4
Fatigability Questionnaire (Physical Subscale)
Time frame: Week 4
Montreal Cognitive Assessment
Time frame: Week 4
Circulating (Plasma) microRNA
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Anton, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting in people with Overweight, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability (time frame: Week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.