Back to resultsTime Restricted Eating on Cancer Risk (TREC)
Primary Purpose
Pre-diabetes, Breast Cancer, Time Restricted Feeding
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted feeding
Control
Sponsored by
About this trial
This is an interventional prevention trial for Pre-diabetes
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 40 and ≤ 60;
- 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 done in the Medical University of South Carolina (MUSC) system and available in electronic medical record (EMR) for confirmation;
- Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
- Self-reported eating interval of ≥ 12 hours per day (eating interval includes habitual eating time period from first food or snack or calorie containing beverage intake to last food or snack or calorie containing beverage intake, more than 5 days per week).
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.
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Time restricted feeding
Control
Arm Description
daily eating period of 8 hours, before 8 PM
daily eating period ≥ 12 hours
Outcomes
Primary Outcome Measures
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.
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. .The intervention and control groups of AGE and sRAGE levels will be used to determined AGE by sRAGE ratio
Assess feasibility and adherence to time period of eating recommendations in both study groups.
Proportion of days that time period of eating was followed.
Secondary Outcome Measures
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.
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.
Difference in Glasgow Prognostic Scoring System
The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. Difference within groups and between groups of the cumulative inflammation-based cancer-prognostic marker. 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
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
Number of participants in the intervention and control group that completed virtual visits with the psychologist.
Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.
Proportion of days that time period of eating was followed.
Time restricted feeding affected sleep patterns
Change in sleep pattern between intervention and control groups as assessed using American Academy of Sleep Medicine 2 week sleep diaries.
Peripheral blood mononuclear cell (PMBC) analysis
Peripheral blood mononuclear cells will be analyzed for RAGE expression and compared within and between intervention and control groups.
Continuous Glucose Monitor (CGM) derived metrics
Mean glucose, standard deviation (SD) of mean glucose values, co-efficient of variation (CV %) of sensor glucose levels, glucose management indicator (GMI%) from CGM data. 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.
Full Information
NCT ID
NCT05038137
First Posted
August 31, 2021
Last Updated
May 10, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05038137
Brief Title
Time Restricted Eating on Cancer Risk
Acronym
TREC
Official Title
The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Breast Cancer, Time Restricted Feeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time restricted feeding
Arm Type
Experimental
Arm Description
daily eating period of 8 hours, before 8 PM
Arm Title
Control
Arm Type
Active Comparator
Arm Description
daily eating period ≥ 12 hours
Intervention Type
Behavioral
Intervention Name(s)
Time restricted feeding
Intervention Description
Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Participants will have a daily eating period equal to or greater than 12 hours.
Primary Outcome Measure Information:
Title
Change in Advanced Glycation End Products (AGE) as assessed by plasma
Description
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 and Visit 2 approximately 12 weeks
Title
Change in sRAGE(soluble receptor for AGE) levels
Description
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. .The intervention and control groups of AGE and sRAGE levels will be used to determined AGE by sRAGE ratio
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Title
Assess feasibility and adherence to time period of eating recommendations in both study groups.
Description
Proportion of days that time period of eating was followed.
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Secondary Outcome Measure Information:
Title
Change in Fasting insulin-like growth factor-1 (IGF-1) levels
Description
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 and Visit 2, approximately 12 weeks
Title
Change in Fasting insulin levels
Description
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 and Visit 2, approximately 12 weeks
Title
Difference in Glasgow Prognostic Scoring System
Description
The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. Difference within groups and between groups of the cumulative inflammation-based cancer-prognostic marker. 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 and Visit 2, approximately 12 weeks
Title
Change in 24 hour urinary AGE levels
Description
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 and Visit 2, approximately 12 weeks
Title
Adherence to virtual visit with psychologist or dietician
Description
Number of participants in the intervention and control group that completed virtual visits with the psychologist.
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Title
Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.
Description
Proportion of days that time period of eating was followed.
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Title
Time restricted feeding affected sleep patterns
Description
Change in sleep pattern between intervention and control groups as assessed using American Academy of Sleep Medicine 2 week sleep diaries.
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Title
Peripheral blood mononuclear cell (PMBC) analysis
Description
Peripheral blood mononuclear cells will be analyzed for RAGE expression and compared within and between intervention and control groups.
Time Frame
Visit 1 and Visit 2, approximately 12 weeks
Title
Continuous Glucose Monitor (CGM) derived metrics
Description
Mean glucose, standard deviation (SD) of mean glucose values, co-efficient of variation (CV %) of sensor glucose levels, glucose management indicator (GMI%) from CGM data. 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 and Visit 2, approximately 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
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).
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Spillers
Phone
843-876-0977
Email
spillerl@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harsha Karanchi, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Spillers
12. IPD Sharing Statement
Plan to Share IPD
No
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Time Restricted Eating on Cancer Risk
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