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Time to Eat Study - Pilot

Primary Purpose

Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Fasting
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Florida Institute on Aging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intermittent fasting

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [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.
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.
Retention
Retention is measured by drop-out rate. Participants are considered "completed" if the Week 4 clinic visit is completed.
Recruitment yields
Recruitment yields is measured by the number of individuals who do not meet the eligibility criteria at the phone interview and/or in-person visit.

Secondary Outcome Measures

6 Minute Walk Test
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.
Grip Strength
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.
Montreal Cognitive Assessment
The Montreal Cognitive Assessment is a 30-point assessment of mild cognitive impairment, which assesses the domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Different versions of the test are given at the two time points to avoid learning effects between repeated administrations of the test.
Fatigability Questionnaire
A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability.
Body Weight
Body weight will be measured following the removal of excess clothing and shoes with calibrated scales.
Waist Circumference
Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
Activity Monitor
A wrist activity monitor accelerometer to measure daily activity level is worn for the duration of the 4-week study intervention.
Systemic Inflammatory biomarkers
Inflammatory biomarkers (CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
Health-related quality of life
Self-administered, 12-item questionnaire to measure health-related quality of life

Full Information

First Posted
June 8, 2018
Last Updated
May 16, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03590847
Brief Title
Time to Eat Study - Pilot
Official Title
Time to Eat Study - Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
September 5, 2018 (Actual)
Study Completion Date
September 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intermittent fasting
Arm Type
Experimental
Arm Description
Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent Fasting
Other Intervention Name(s)
Time Restricted Feeding
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
Week 4
Title
Adherence
Description
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.
Time Frame
Week 4
Title
Retention
Description
Retention is measured by drop-out rate. Participants are considered "completed" if the Week 4 clinic visit is completed.
Time Frame
Week 4
Title
Recruitment yields
Description
Recruitment yields is measured by the number of individuals who do not meet the eligibility criteria at the phone interview and/or in-person visit.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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.
Time Frame
Baseline and Week 4
Title
Grip Strength
Description
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.
Time Frame
Baseline and Week 4
Title
Montreal Cognitive Assessment
Description
The Montreal Cognitive Assessment is a 30-point assessment of mild cognitive impairment, which assesses the domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Different versions of the test are given at the two time points to avoid learning effects between repeated administrations of the test.
Time Frame
Baseline and Week 4
Title
Fatigability Questionnaire
Description
A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability.
Time Frame
Baseline and Week 4
Title
Body Weight
Description
Body weight will be measured following the removal of excess clothing and shoes with calibrated scales.
Time Frame
Baseline and Week 4
Title
Waist Circumference
Description
Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
Time Frame
Baseline and Week 4
Title
Activity Monitor
Description
A wrist activity monitor accelerometer to measure daily activity level is worn for the duration of the 4-week study intervention.
Time Frame
Baseline and Week 4
Title
Systemic Inflammatory biomarkers
Description
Inflammatory biomarkers (CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
Time Frame
Baseline and Week 4
Title
Health-related quality of life
Description
Self-administered, 12-item questionnaire to measure health-related quality of life
Time Frame
Baseline and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Anton, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Institute on Aging
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Time to Eat Study - Pilot

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