Breast Cancer, Pre-diabetes, Time Restricted Feeding
Conditions
Brief summary
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.
Interventions
BEHAVIORALTime restricted feeding
Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
BEHAVIORALControl
Participants will have a daily eating period equal to or greater than 12 hours.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Visit 1 at 0 weeks, followed by 2 week run-in and then randomization. Visit 2 at 14 weeks.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 40 and ≤ 67; * 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). A1c lab and/or fasting glucose criteria will need to be met within 12 months of signing consent form, can be obtained from prior lab result or study prescreening testing; * Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
Exclusion criteria
* Tobacco use (current or within last 2 years); * Active malignancy or history of cancer; * History of known liver disease (by serology: aspartate aminotransferase or alanine aminotransferase ≥ 3 times above upper limit of normal determined by lab review, imaging or biopsy: determined by patient history); * History of kidney disease (patient history and/or estimated glomerular filtration rate less than 45 mL/min/1.73m²); * History of diabetes mellitus: * History of cardiovascular disease (MI, CHF); * Current prescription medication use for diabetes; * Medication affecting glucose metabolism or appetite or immunosuppression; * Dietary restrictions: currently following vegetarian or vegan dietary pattern; * Currently following intermittent fasting or time restricted feeding pattern or use in the last 3 months; * Night shift worker (work schedule does not involve any period of work from 10 PM to 5 AM either on a regular or rotating basis); * History of weight loss \>5% in the last 3 months; * History of weight loss surgery. * BMI≥40 kg/m² exclusion; * After informed consent and run in period: Insufficient documented food photography/annotated entries (does not log at least two entries a day for 10 of 14 days) during run in period will be excluded from randomization in to the intervention period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Advanced Glycation End Products (AGE) as Assessed by Plasma | 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. |
| Change in sRAGE(Soluble Receptor for AGE) Levels | 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. |
| Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups. | Visit 1 (0 weeks), Visit 2 (14 weeks) | Percentage of dietary visits that participant reported compliance with randomized eating period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels | 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. |
| Change in Fasting Insulin Levels | 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. |
| Difference in Glasgow Prognostic Scoring System | 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. |
| Change in 24 Hour Urinary AGE Levels | 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. |
| Adherence to Virtual Visit With Psychologist or Dietician | Visit 1 (0 weeks), Visit 2 (14 weeks) | Percentage of expected visits attended. |
| Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries. | 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. |
| Percentage of Participants With Stable Chronotype Between Baseline and End of Study | 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. |
| Mean Glucose at Visit 2 | 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). |
| Glucose Management Indicator (GMI) at Visit 2 | Visit 2 (14 weeks) | GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2). |
| Glucose Variability at Visit 2 | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHarsha Karanchi, MD
Medical University of South Carolina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Control daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours. | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Control | Total | Time Restricted Feeding |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 6.1 | 58.4 years STANDARD_DEVIATION 5.9 | 58.4 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 18 Participants | 10 Participants |
| Region of Enrollment United States | 14 participants | 29 participants | 15 participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups. | 90.1 Percentage of visits |
| Control | Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups. | 83.3 Percentage of visits |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Time Restricted Feeding | Change in Advanced Glycation End Products (AGE) as Assessed by Plasma | Visit 1 (0 weeks) | 5.82 ng/mL |
| Time Restricted Feeding | Change in Advanced Glycation End Products (AGE) as Assessed by Plasma | Visit 2 (14 weeks) | 5.82 ng/mL |
| Control | Change in Advanced Glycation End Products (AGE) as Assessed by Plasma | Visit 1 (0 weeks) | 6.38 ng/mL |
| Control | Change in Advanced Glycation End Products (AGE) as Assessed by Plasma | Visit 2 (14 weeks) | 6.40 ng/mL |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Time Restricted Feeding | Change in sRAGE(Soluble Receptor for AGE) Levels | Visit 1 (0 weeks) | 2.77 ng/mL |
| Time Restricted Feeding | Change in sRAGE(Soluble Receptor for AGE) Levels | Visit 2 (14 weeks) | 2.64 ng/mL |
| Control | Change in sRAGE(Soluble Receptor for AGE) Levels | Visit 1 (0 weeks) | 2.65 ng/mL |
| Control | Change in sRAGE(Soluble Receptor for AGE) Levels | Visit 2 (14 weeks) | 2.58 ng/mL |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Secondary
Adherence to Virtual Visit With Psychologist or Dietician
Percentage of expected visits attended.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Adherence to Virtual Visit With Psychologist or Dietician | 97.5 Percentage |
| Control | Adherence to Virtual Visit With Psychologist or Dietician | 98.2 Percentage |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Time Restricted Feeding | Change in 24 Hour Urinary AGE Levels | Visit 1 (0 weeks) | 6.51 ng/mL |
| Time Restricted Feeding | Change in 24 Hour Urinary AGE Levels | Visit 2 (14 weeks) | 5.82 ng/mL |
| Control | Change in 24 Hour Urinary AGE Levels | Visit 2 (14 weeks) | 6.02 ng/mL |
| Control | Change in 24 Hour Urinary AGE Levels | Visit 1 (0 weeks) | 6.69 ng/mL |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Change in Fasting Insulin Levels | -0.6 µU/ml |
| Control | Change in Fasting Insulin Levels | 1.0 µU/ml |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Time Restricted Feeding | Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels | 2.5 ng/ml | Standard Deviation 24 |
| Control | Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels | .01 ng/ml | Standard Deviation 16 |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Difference in Glasgow Prognostic Scoring System | 0 score on a scale |
| Control | Difference in Glasgow Prognostic Scoring System | 0 score on a scale |
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).
Time frame: Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Glucose Management Indicator (GMI) at Visit 2 | 6 percentage |
| Control | Glucose Management Indicator (GMI) at Visit 2 | 5.8 percentage |
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).
Time frame: Visit 2 (14 weeks)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Glucose Variability at Visit 2 | 18 percentage |
| Control | Glucose Variability at Visit 2 | 17.6 percentage |
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).
Time frame: Final 14 days of intervention period (Visit 2).
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Time Restricted Feeding | Mean Glucose at Visit 2 | 113.8 mg/dL |
| Control | Mean Glucose at Visit 2 | 101.9 mg/dL |
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.
Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Time Restricted Feeding | Percentage of Participants With Stable Chronotype Between Baseline and End of Study | 0.923 % of participants with stable chronotype |
| Control | Percentage of Participants With Stable Chronotype Between Baseline and End of Study | 0.857 % of participants with stable chronotype |