Time to Eat Study - Pilot

University of Florida

Status: Completed

Conditions: Overweight

Treatments: Behavioral: Intermittent Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT03590847

IRB201801293

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intermittent fasting

Experimental group

Description:

Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks.

Treatment:

Behavioral: Intermittent Fasting