Time Restricted Eating on Cancer Risk
Completed · Not applicable
Conditions studied: Pre-diabetes, Breast Cancer, Time Restricted Feeding
In brief
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.
Key facts
- Study ID
- NCT05038137
- Run by
- Medical University of South Carolina
- People needed
- 29
- Starts
- 2022-05-04
- Expected to finish
- 2024-04-23
- Last updated by the study team
- 2026-06-02
Who can join
Age: 40 and older, up to 67. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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