Time to Eat Study - Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- University of Florida
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Body Weight(Week 4)
- Body Mass Index (BMI)(Week 4)
- Waist Circumference(Week 4)
- Blood Glucose(Week 4)
- Systolic Blood Pressure(Week 4)
- Diastolic Blood Pressure(Week 4)
- 6 Minute Walk Test (Meters)(Week 4)
- 6 Minute Walk Test (m/s)(Week 4)
- Grip Strength (Dominant Hand)(Week 4)
- 12-Item Short Form Survey Physical Function (Summary Score)(Week 4)
- 12-Item Short Form Survey Mental Function (Summary Score)(Week 4)
- 12-Item Short Form Survey Total Score(Week 4)
- Fatigability Questionnaire (Mental Subscale)(Week 4)
- Fatigability Questionnaire (Physical Subscale)(Week 4)
- Montreal Cognitive Assessment(Week 4)
- Circulating (Plasma) microRNA(Week 4)