Clinical trial NCT05038137: Time Restricted Eating on Cancer Risk
Official title: The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Breast Cancer
Time Restricted Feeding
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 29
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 ≤ 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.

Primary outcomes:
measure: Change in Advanced Glycation End Products (AGE) as assessed by plasma
timeFrame: Visit 1 and Visit 2 approximately 12 weeks
measure: Change in sRAGE(soluble receptor for AGE) levels
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Assess feasibility and adherence to time period of eating recommendations in both study groups.
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
Secondary outcomes:
measure: Change in Fasting insulin-like growth factor-1 (IGF-1) levels
timeFrame: Visit and Visit 2, approximately 12 weeks
measure: Change in Fasting insulin levels
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Difference in Glasgow Prognostic Scoring System
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Change in 24 hour urinary AGE levels
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Adherence to virtual visit with psychologist or dietician
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Time restricted feeding affected sleep patterns
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Peripheral blood mononuclear cell (PMBC) analysis
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
measure: Continuous Glucose Monitor (CGM) derived metrics
timeFrame: Visit 1 and Visit 2, approximately 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Harsha Karanchi, MD
role: PRINCIPAL_INVESTIGATOR
References: