Time Restricted Eating on Cancer Risk (TREC)

The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Time Restricted Feeding; Pre-diabetes
• Intervention / Treatment: Behavioral: Time restricted feeding; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time restricted feeding; daily eating period of 8 hours, before 8 PM for 12 weeks	Behavioral: Time restricted feeding; Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
Active Comparator: Control; daily eating period ≥ 12 hours for 12 weeks	Behavioral: Control; Participants will have a daily eating period equal to or greater than 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Harsha Karanchi, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Actual): April 23, 2024
• Study Completion (Actual): April 23, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Breast Diseases; Hyperglycemia; Behavior; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Feeding Behavior; Fasting; Breast Neoplasms; Glucose Intolerance; Intermittent Fasting
• Other Study ID Numbers: 109489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No