Time to Eat Study - Pilot

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Time to Eat Study - Pilot

Conditions
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Overweight

Intervention / Treatment
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* Behavioral: Intermittent Fasting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent fasting<br>Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. | Behavioral: Intermittent Fasting<br>* 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.<br>* Other names: Time Restricted Feeding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 4 | 
| 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. | Week 4 | 
| Retention | Retention is measured by drop-out rate. Participants are considered completed if the Week 4 clinic visit is completed. | Week 4 | 
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Week 4 | 
| 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. | Baseline and Week 4 | 
| 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. | Baseline and Week 4 | 
| Fatigability Questionnaire | A self-administered, 26-item questionnaire to measure perceived mental and physical fatigability. | Baseline and Week 4 | 
| Body Weight | Body weight will be measured following the removal of excess clothing and shoes with calibrated scales. | Baseline and Week 4 | 
| Waist Circumference | Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone. | Baseline and Week 4 | 
| Activity Monitor | A wrist activity monitor accelerometer to measure daily activity level is worn for the duration of the 4-week study intervention. | Baseline and Week 4 | 
| Systemic Inflammatory biomarkers | Inflammatory biomarkers (CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay). | Baseline and Week 4 | 
| Health-related quality of life | Self-administered, 12-item questionnaire to measure health-related quality of life | Baseline and Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intermittent fasting, Inflammation, Diet, Lifestyle, Eating habits, Time Restricted Feeding