Time to Eat Study - Pilot

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: Completed
• Conditions: Overweight
• Intervention / Treatment: Behavioral: Intermittent Fasting

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: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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.	Week 4
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.	Week 4
Retention	Number of Participants who dropped out before the Week 4 clinic visit was completed.	Week 4
Recruitment Yields	Recruitment yields is measured by the number of individuals who were assessed at phone screening.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 4
Body Mass Index (BMI)	Measure of body fat using weight from previous weight measurement.	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.	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.	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.	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.	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.	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).	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).	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.	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.	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.	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.	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.	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.	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.	Week 4

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Stephen Anton, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 5, 2018
• Study Completion (Actual): September 5, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Diet; Eating habits; Lifestyle; Intermittent fasting; Time Restricted Feeding
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID 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