Time Restricted Eating on Cancer Risk

Breast Cancer Clinical Trial

— TREC  

Official title:

The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05038137
• Other study ID #: 109489
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Pre-diabetes
• Prediabetic State
• Time Restricted Feeding

Intervention

Behavioral:
• Time restricted feeding
Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
• Control
Participants will have a daily eating period equal to or greater than 12 hours.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Advanced Glycation End Products (AGE) as assessed by plasma	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.	Visit 1 and Visit 2 approximately 12 weeks
Primary	Change in sRAGE(soluble receptor for AGE) levels	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	Visit 1 and Visit 2, approximately 12 weeks
Primary	Assess feasibility and adherence to time period of eating recommendations in both study groups.	Proportion of days that time period of eating was followed.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Change in Fasting insulin-like growth factor-1 (IGF-1) levels	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.	Visit and Visit 2, approximately 12 weeks
Secondary	Change in Fasting insulin levels	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.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Difference in Glasgow Prognostic Scoring System	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.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Change in 24 hour urinary AGE levels	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.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Adherence to virtual visit with psychologist or dietician	Number of participants in the intervention and control group that completed virtual visits with the psychologist.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Adherence to time period of eating recommendation in both study groups: self reporting during virtual visits and through food photography / annotated entries.	Proportion of days that time period of eating was followed.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Time restricted feeding affected sleep patterns	Change in sleep pattern between intervention and control groups as assessed using American Academy of Sleep Medicine 2 week sleep diaries.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Peripheral blood mononuclear cell (PMBC) analysis	Peripheral blood mononuclear cells will be analyzed for RAGE expression and compared within and between intervention and control groups.	Visit 1 and Visit 2, approximately 12 weeks
Secondary	Continuous Glucose Monitor (CGM) derived metrics	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.	Visit 1 and Visit 2, approximately 12 weeks