Time Restricted Eating on Cancer Risk (TREC)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Breast Cancer; Pre-diabetes; Time Restricted Feeding

Treatments: Behavioral: Control; Behavioral: Time restricted feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT05038137

109489

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 40 to 67 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Time restricted feeding

Experimental group

Description:

daily eating period of 8 hours, before 8 PM for 12 weeks

Treatment:

Behavioral: Time restricted feeding

Control

Active Comparator group

Description:

daily eating period ≥ 12 hours for 12 weeks

Treatment:

Behavioral: Control