Time to Eat Study - Pilot



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:65 - Any
Updated:10/17/2018
Start Date:June 28, 2018
End Date:September 5, 2018

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The goals of this pilot study is to evaluate the safety and feasibility of time restricted
feeding in an older adult population.

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.

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
We found this trial at
1
site
Gainesville, Florida 32610
Phone: 352-273-5919
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from
Gainesville, FL
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