Recruiting

Time Restricted Eating

Sponsor:

University of Illinois at Chicago

Code:

NCT05259410

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

TRE

MedTRE

Study Details

Brief summary:

Breast cancer is the most common cancer in the United States however, little is known about how diet can affect cancer treatment. Pre-clinical murine studies report intermittent fasting increases effectiveness of chemotherapy and decreases treatment related adverse events. The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related outcomes, and limit treatment related weight gain and fat mass accretion.Time restricted eating combined with a mediterranean diet will also be feasible and improve cardiometabolic risk more than TRE alone or standard care.

Conditions

Breast Cancer Female

Study ID

NCT05259410

Start date

Aug 1, 2022

Status verified date

Feb, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 25-99 at time of consent
  • ECOG 0 or 1
  • Breast cancer to meet histologically confirmed Stage I-III.
  • Demonstrates adequate organ function (absolutely neutrophil count ≥ 1,500/μL).
  • All screening labs to be obtained within 30 days prior to registration.
  • Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
  • Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
  • As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

  • Women with metastatic disease or type 1 or 2 diabetes
  • Women with BMI ≥ 40kg/m2 and < 25kg/m2
  • Women who are pregnant. A negative serum or urine pregnancy test is required per institutional practice guidelines.
  • Night shift workers
  • Women with a history of eating disorders
  • Enrolled participants with a significant weight loss or weight gain within 3 months of the study (weight gain or loss >4kg)
  • Active infection requiring systemic therapy
  • Uncontrolled HIV/AIDS or active viral hepatitis
  • Pregnant or nursing
  • Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
  • Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial.
  • Other major comorbidity, as determined by study PI
  • Illicit drug use or excessive use of alcohol (i.e., > 2 drinks/day)
  • Currently participating in Weight Watcher's or another weight loss program
  • Myocardial infarction
  • Stroke
  • Congestive heart failure
  • Chronic hepatitis
  • Cirrhosis
  • Chronic pancreatitis
  • History of solid organ transplantation

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time restricted eating

Participants will eat all food within the same self selected 8 hour window daily.

no intervention: Standard care

Current standard care is to eat enough calories and protein to maintain weight and lean mass.

experimental: Med TRE

Participants will eat a mediterranean style diet within the same self selected 8 hour window daily.

Interventions

TRE

All food eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.

MedTRE

A mediterranean style diet will be eaten within the same self-selected 8 hour eating window daily, water fasting the remaining hours of the day.

Primary outcome measure

  • Feasibility 8-h TRE [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kelsey Gabel, PhD

312-413-8911kdipma2@uic.edu

Locations

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Oct 1, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-10-01.