Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT05038137
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.
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Notify Me40 year–67 year
Female
Interventional
Not applicable
Charleston, South Carolina, 29425, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
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)
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)
Percentage of dietary visits that participant reported compliance with randomized eating period.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
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)
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)
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
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)
Percentage of expected visits attended.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
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)
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: Final 14 days of intervention period (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: Visit 2 (14 weeks)
GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2).
Time frame: Visit 2 (14 weeks)
Coefficient of variation of glucose levels derived from CGM data during the final 14 days of the intervention period (Visit 2).
Medical University of South Carolina
Other
The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
Acronym: TREC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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