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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time restricted feeding | Experimental | daily eating period of 8 hours, before 8 PM for 12 weeks |
|
| Control | Active Comparator | daily eating period ≥ 12 hours for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time restricted feeding | Behavioral | Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Visit 1 (0 weeks), Visit 2 (14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1 (0 weeks), Visit 2 (14 weeks) |
| Change in Fasting Insulin Levels |
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Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women (no menstrual periods in the preceding 12 or more months) with pre-diabetes (A1C 5.7-6.4% and/or fasting glucose 100-125 mg/dL).
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| Name | Affiliation | Role |
|---|---|---|
| Harsha Karanchi, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Time Restricted Feeding | daily eating period of 8 hours, before 8 PM Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM for 12 weeks. |
| FG001 | Control | daily eating period ≥ 12 hours Control: Participants will have a daily eating period equal to or greater than 12 hours for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Time Restricted Feeding | daily eating period of 8 hours, before 8 PM Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | ng/mL | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Time Restricted Feeding | daily eating period of 8 hours, before 8 PM Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karanchi | Medical University of South Carolina | (843) 792-2529 | karanchi@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2025 | Jun 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2023 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D001943 | Breast Neoplasms |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Visit 1 at 0 weeks, followed by 2 week run-in and then randomization. Visit 2 at 14 weeks.
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| Control | Behavioral | Participants will have a daily eating period equal to or greater than 12 hours. |
|
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. |
| 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. | 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. | Visit 1 (0 weeks), Visit 2 (14 weeks) |
| Adherence to Virtual Visit With Psychologist or Dietician | Percentage of expected visits attended. | 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. | 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. | 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). | 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). | 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). | Visit 2 (14 weeks) |
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | ng/mL | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Primary | 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. | Posted | Mean | Full Range | Percentage of visits | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | µU/ml | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | score on a scale | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | ng/mL | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | Adherence to Virtual Visit With Psychologist or Dietician | Percentage of expected visits attended. | Posted | Mean | Full Range | Percentage | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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. | Not Posted | Jan 2027 | Visit 1 (0 weeks), Visit 2 (14 weeks) | Participants |
| Secondary | 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. | All randomized participants who completed both baseline and end-of-study sleep diaries were included in the analysis. Stability was defined as no change in chronotype classification between Visit 1 and Visit 2. | Posted | Number | 95% Confidence Interval | % of participants with stable chronotype | Visit 1 (0 weeks), Visit 2 (14 weeks) |
|
|
|
| Secondary | 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). | All randomized participants who completed CGM monitoring during the final 14 days of the intervention period were included in the analysis. Mean glucose was calculated as the average of all CGM readings during this period. | Posted | Mean | 95% Confidence Interval | mg/dL | Final 14 days of intervention period (Visit 2). |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | percentage | Visit 2 (14 weeks) |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | percentage | Visit 2 (14 weeks) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | daily eating period ≥ 12 hours Control: Participants will have a daily eating period equal to or greater than 12 hours. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |