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Completed

NCT Number: NCT05038137

Time Restricted Eating on Cancer Risk

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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Key information

Age range

40 year–67 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time restricted feeding

Behavioral

Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.

Control

Behavioral

Participants will have a daily eating period equal to or greater than 12 hours.

Primary outcomes

  1. Change in Advanced Glycation End Products (AGE) as Assessed by Plasma

    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.

  2. Change in sRAGE(Soluble Receptor for AGE) Levels

    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.

  3. Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.

    Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)

    Percentage of dietary visits that participant reported compliance with randomized eating period.

Secondary outcomes

  1. Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels

    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.

  2. Change in Fasting Insulin Levels

    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.

  3. Difference in Glasgow Prognostic Scoring System

    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.

  4. Change in 24 Hour Urinary AGE Levels

    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.

  5. Adherence to Virtual Visit With Psychologist or Dietician

    Time frame: Visit 1 (0 weeks), Visit 2 (14 weeks)

    Percentage of expected visits attended.

  6. Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries.

    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.

  7. Percentage of Participants With Stable Chronotype Between Baseline and End of Study

    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.

  8. Mean Glucose at 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).

  9. Glucose Management Indicator (GMI) at 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).

  10. Glucose Variability at 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).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Acronym: TREC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2021
Registry last updated
Jun 2, 2026

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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