Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours. There are 2 in-person study visits to have blood, urine and vital signs collected and 8 remote or phone visits with a psychologist or dietician to assist with the eating schedule. The study will take last 3 1/2 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
29
Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
Participants will have a daily eating period equal to or greater than 12 hours.
Medical University of South Carolina
Charleston, South Carolina, United States
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in sRAGE(Soluble Receptor for AGE) Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.
Percentage of dietary visits that participant reported compliance with randomized eating period.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in Fasting Insulin Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Difference in Glasgow Prognostic Scoring System
The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. GPS is a three-tiered score \[0: normal C-reactive protein (CRP) and albumin; 1: one abnormal result; 2: increased CRP and low albumin\]. Higher score means worse outcome.
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Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Change in 24 Hour Urinary AGE Levels
Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Virtual Visit With Psychologist or Dietician
Percentage of expected visits attended.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.
Proportion of dietary visits where participants reported compliance with randomized eating period, assessed through self-report during virtual visits and via food photography/annotated entries.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of Participants With Stable Chronotype Between Baseline and End of Study
Stability in chronotype (normal, delayed, or advanced) was assessed using 2-week sleep diaries at baseline and end of study. Stability was defined as no change in chronotype classification between Visit 1 and Visit 2.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Mean Glucose at Visit 2
Mean glucose level calculated as the average of continuous glucose monitoring (CGM) data collected during the final 14 days of the intervention period (Visit 2).
Time frame: Final 14 days of intervention period (Visit 2).
Glucose Management Indicator (GMI) at Visit 2
GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2).
Time frame: Visit 2 (14 weeks)
Glucose Variability at Visit 2
Coefficient of variation of glucose levels derived from CGM data during the final 14 days of the intervention period (Visit 2).
Time frame: Visit 2 (14 weeks)