- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03590847
Time to Eat Study - Pilot
May 16, 2019 updated by: University of Florida
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida Institute on Aging
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intermittent fasting
Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [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.
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Week 4
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Adherence
Time Frame: Week 4
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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.
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Week 4
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Retention
Time Frame: Week 4
|
Retention is measured by drop-out rate.
Participants are considered "completed" if the Week 4 clinic visit is completed.
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Week 4
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Recruitment yields
Time Frame: Baseline
|
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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Minute Walk Test
Time Frame: Baseline and Week 4
|
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.
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Baseline and Week 4
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Grip Strength
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Montreal Cognitive Assessment
Time Frame: Baseline and Week 4
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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.
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Baseline and Week 4
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Fatigability Questionnaire
Time Frame: Baseline and Week 4
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A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability.
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Baseline and Week 4
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Body Weight
Time Frame: Baseline and Week 4
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Body weight will be measured following the removal of excess clothing and shoes with calibrated scales.
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Baseline and Week 4
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Waist Circumference
Time Frame: Baseline and Week 4
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Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
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Baseline and Week 4
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Activity Monitor
Time Frame: Baseline and Week 4
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A wrist activity monitor accelerometer to measure daily activity level is worn for the duration of the 4-week study intervention.
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Baseline and Week 4
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Systemic Inflammatory biomarkers
Time Frame: Baseline and Week 4
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Inflammatory biomarkers (CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).
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Baseline and Week 4
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Health-related quality of life
Time Frame: Baseline and Week 4
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Self-administered, 12-item questionnaire to measure health-related quality of life
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Baseline and Week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 28, 2018
Primary Completion (ACTUAL)
September 5, 2018
Study Completion (ACTUAL)
September 5, 2018
Study Registration Dates
First Submitted
June 8, 2018
First Submitted That Met QC Criteria
July 6, 2018
First Posted (ACTUAL)
July 18, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 20, 2019
Last Update Submitted That Met QC Criteria
May 16, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201801293
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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