N/A
N=29
Time Restricted Eating on Cancer Risk
Pre-diabetes · Breast Cancer · Time Restricted Feeding
Bottom Line
View on ClinicalTrials.gov: NCT05038137 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Advanced Glycation End Products (AGE) as Assessed by Plasma — 5.82; 6.38; 5.82; 6.40 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Time restricted feeding (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Advanced Glycation End Products (AGE) as Assessed by Plasma |
5.82; 6.38; 5.82; 6.40 | — |
| PRIMARY Change in sRAGE(Soluble Receptor for AGE) Levels |
2.77; 2.65; 2.64; 2.58 | — |
| PRIMARY Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups. |
90.1; 83.3 | — |
| SECONDARY Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels |
2.5; .01 | — |
| SECONDARY Change in Fasting Insulin Levels |
-0.6; 1.0 | — |
| SECONDARY Difference in Glasgow Prognostic Scoring System |
0; 0 | — |
| SECONDARY Change in 24 Hour Urinary AGE Levels |
6.51; 6.69; 5.82; 6.02 | — |
| SECONDARY Adherence to Virtual Visit With Psychologist or Dietician |
97.5; 98.2 | — |
| SECONDARY Adherence to Time Period of Eating Recommendation in Both Study Groups: Self Reporting During Virtual Visits and Through Food Photography / Annotated Entries. |
— | — |
| SECONDARY Percentage of Participants With Stable Chronotype Between Baseline and End of Study |
0.923; 0.857 | — |
| SECONDARY Mean Glucose at Visit 2 |
113.8; 101.9 | — |
| SECONDARY Glucose Management Indicator (GMI) at Visit 2 |
6; 5.8 | — |
| SECONDARY Glucose Variability at Visit 2 |
18; 17.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05038137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.