Breast Cancer Clinical Trial
Time Restricted Eating on Cancer Risk
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Age ≥ 40 and ≤ 60;
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 done in the Medical University of South Carolina (MUSC) system and available in electronic medical record (EMR) for confirmation;
Own a smart phone with internet connection and capable of receiving and sending text messages and taking photographs;
Self-reported eating interval of ≥ 12 hours per day (eating interval includes habitual eating time period from first food or snack or calorie containing beverage intake to last food or snack or calorie containing beverage intake, more than 5 days per week).
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.
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There is 1 Location for this study
Charleston South Carolina, 29425, United States More Info
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