Clinical trial · Interventional
Time Restricted Eating on Cancer Risk
The Effects of Time Restricted Feeding on AGE-RAGE Signaling in Women at High Risk for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pre-diabetes | — | UNRESOLVED | — |
| Time Restricted Feeding | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| Time restricted feeding | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Time restricted feeding
- description
- daily eating period of 8 hours, before 8 PM for 12 weeks
- interventionNames
- Behavioral: Time restricted feeding
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- daily eating period ≥ 12 hours for 12 weeks
- interventionNames
- Behavioral: Control
Primary outcomes (3)
- measure
- Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
- timeFrame
- Visit 1 (0 weeks), Visit 2 (14 weeks)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 67 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available