N/A
Completed N=10
Time to Eat Study - Pilot
Source: ClinicalTrials.gov NCT03590847 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability — 3 Participants
Summary
The goals of this pilot study is to evaluate the safety and feasibility of time restricted feeding in an older adult population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability |
3 | — |
| PRIMARY Adherence |
84 | — |
| PRIMARY Retention |
1 | — |
| PRIMARY Recruitment Yields |
65 | — |
| SECONDARY Body Weight |
94.81 | — |
| SECONDARY Body Mass Index (BMI) |
33.2 | — |
| SECONDARY Waist Circumference |
109.23 | — |
| SECONDARY Blood Glucose |
107.3 | — |
| SECONDARY Systolic Blood Pressure |
148.22 | — |
| SECONDARY Diastolic Blood Pressure |
78.89 | — |
| SECONDARY 6 Minute Walk Test (Meters) |
310.89 | — |
| SECONDARY 6 Minute Walk Test (m/s) |
0.92 | — |
| SECONDARY Grip Strength (Dominant Hand) |
24.0 | — |
| SECONDARY 12-Item Short Form Survey Physical Function (Summary Score) |
14.9 | — |
| SECONDARY 12-Item Short Form Survey Mental Function (Summary Score) |
22.8 | — |
| SECONDARY 12-Item Short Form Survey Total Score |
37.7 | — |
| SECONDARY Fatigability Questionnaire (Mental Subscale) |
14.7 | — |
| SECONDARY Fatigability Questionnaire (Physical Subscale) |
24.9 | — |
| SECONDARY Montreal Cognitive Assessment |
25.9 | — |
| SECONDARY Circulating (Plasma) microRNA |
14; 8; 6 | — |
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 ( 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
Data sourced from ClinicalTrials.gov (NCT03590847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.