Time Restricted Eating on Cancer Risk
- Conditions
- Pre-diabetesTime Restricted FeedingBreast Cancer
- Interventions
- Behavioral: ControlBehavioral: Time restricted feeding
- Registration Number
- NCT05038137
- Lead Sponsor
- Medical University of South Carolina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control daily eating period ≥ 12 hours Time restricted feeding Time restricted feeding daily eating period of 8 hours, before 8 PM
- Primary Outcome Measures
Name Time Method Assess feasibility and adherence to time period of eating recommendations in both study groups. Visit 1 and Visit 2, approximately 12 weeks Proportion of days that time period of eating was followed.
Change in sRAGE(soluble receptor for AGE) levels Visit 1 and Visit 2, approximately 12 weeks Estimated mean levels within the intervention and the control groups of the study. Effect size will estimated via 95% confidence intervals within and between groups. .The intervention and control groups of AGE and sRAGE levels will be used to determined AGE by sRAGE ratio
Change in Advanced Glycation End Products (AGE) as assessed by plasma Visit 1 and Visit 2 approximately 12 weeks Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
- Secondary Outcome Measures
Name Time Method Change in 24 hour urinary AGE levels Visit 1 and Visit 2, approximately 12 weeks Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.
Time restricted feeding affected sleep patterns Visit 1 and Visit 2, approximately 12 weeks Change in sleep pattern between intervention and control groups as assessed using American Academy of Sleep Medicine 2 week sleep diaries.
Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries. Visit 1 and Visit 2, approximately 12 weeks Proportion of days that time period of eating was followed.
Continuous Glucose Monitor (CGM) derived metrics Visit 1 and Visit 2, approximately 12 weeks Mean glucose, standard deviation (SD) of mean glucose values, co-efficient of variation (CV %) of sensor glucose levels, glucose management indicator (GMI%) from CGM data. Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated by the 95% confidence intervals within and between groups.
Change in Fasting insulin-like growth factor-1 (IGF-1) levels Visit and Visit 2, approximately 12 weeks Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Change in Fasting insulin levels Visit 1 and Visit 2, approximately 12 weeks Estimated mean levels within the intervention and the control groups of the study. Effect size will be estimated via 95% confidence intervals within and between groups.
Difference in Glasgow Prognostic Scoring System Visit 1 and Visit 2, approximately 12 weeks The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. Difference within groups and between groups of the cumulative inflammation-based cancer-prognostic marker. GPS is a three-tiered score \[0: normal C-reactive protein (CRP) and albumin; 1: one abnormal result; 2: increased CRP and low albumin\]. Higher score means worse outcome.
Adherence to virtual visit with psychologist or dietician Visit 1 and Visit 2, approximately 12 weeks Number of participants in the intervention and control group that completed virtual visits with the psychologist.
Peripheral blood mononuclear cell (PMBC) analysis Visit 1 and Visit 2, approximately 12 weeks Peripheral blood mononuclear cells will be analyzed for RAGE expression and compared within and between intervention and control groups.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States