Clinical trial NCT03590847: Time to Eat Study - Pilot
Official title: Time to Eat Study - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Intermittent fasting
Inflammation
Diet
Lifestyle
Eating habits
Time Restricted Feeding
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
  * 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability
timeFrame: Week 4
measure: Adherence
timeFrame: Week 4
measure: Retention
timeFrame: Week 4
measure: Recruitment Yields
timeFrame: Baseline
Secondary outcomes:
measure: Body Weight
timeFrame: Week 4
measure: Body Mass Index (BMI)
timeFrame: Week 4
measure: Waist Circumference
timeFrame: Week 4
measure: Blood Glucose
timeFrame: Week 4
measure: Systolic Blood Pressure
timeFrame: Week 4
measure: Diastolic Blood Pressure
timeFrame: Week 4
measure: 6 Minute Walk Test (Meters)
timeFrame: Week 4
measure: 6 Minute Walk Test (m/s)
timeFrame: Week 4
measure: Grip Strength (Dominant Hand)
timeFrame: Week 4
measure: 12-Item Short Form Survey Physical Function (Summary Score)
timeFrame: Week 4
measure: 12-Item Short Form Survey Mental Function (Summary Score)
timeFrame: Week 4
measure: 12-Item Short Form Survey Total Score
timeFrame: Week 4
measure: Fatigability Questionnaire (Mental Subscale)
timeFrame: Week 4
measure: Fatigability Questionnaire (Physical Subscale)
timeFrame: Week 4
measure: Montreal Cognitive Assessment
timeFrame: Week 4
measure: Circulating (Plasma) microRNA
timeFrame: Week 4
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Institute on Aging
state: Florida
Study officials:
affiliation: University of Florida
name: Stephen Anton, PhD
role: PRINCIPAL_INVESTIGATOR
References: