Trial results for a study investigating time restricted eating on cancer risk, including breast cancer, were posted on ClinicalTrials.gov on 2025-07-04, with 29 participants enrolled.
Background
Breast cancer is a significant health concern, and research into modifiable risk factors, including dietary patterns, is ongoing. Pre-diabetes is a metabolic condition that can increase the risk of various chronic diseases. Time-restricted eating is a dietary approach that limits food intake to specific hours each day. Biomarkers such as Advanced Glycation End Products (AGE), their soluble receptor (sRAGE), and Insulin-like Growth Factor-1 (IGF-1) are studied for their roles in metabolic health and their potential association with disease risk.
Trial design
This completed study, designated as Phase NA, enrolled 29 participants. The trial investigated conditions including Pre-diabetes and Breast Cancer, with an intervention of Time Restricted Feeding. Participants were randomly assigned to either a time-restricted feeding group with a daily eating period of 8 hours or a control group with a daily eating period of 12 hours or greater. The study aimed to assess changes in biomarkers like Advanced Glycation End Products (AGE), sRAGE, and Insulin-like Growth Factor-1 (IGF-1), as well as the feasibility and adherence to the eating recommendations.
Key results
The trial reported several key measurements:
- Change in Advanced Glycation End Products (AGE) as Assessed by Plasma:
- For the Time Restricted Feeding group, the mean change was 5.82 ng/mL.
- For the Control group, the mean change was 6.38 ng/mL.
- Another measurement showed a mean change of 5.82 ng/mL for the Time Restricted Feeding group and 6.40 ng/mL for the Control group.
- Change in sRAGE(Soluble Receptor for AGE) Levels:
- For the Time Restricted Feeding group, the mean change was 2.77 ng/mL.
- For the Control group, the mean change was 2.65 ng/mL.
- Another measurement showed a mean change of 2.64 ng/mL for the Time Restricted Feeding group and 2.58 ng/mL for the Control group.
- Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.:
- The mean adherence for the Time Restricted Feeding group was 90.1 Percentage of visits.
- The mean adherence for the Control group was 83.3 Percentage of visits.
- Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels:
- For the Time Restricted Feeding group, the mean change was 2.5 ng/ml (Standard Deviation 24).
- For the Control group, the mean change was 0.01 ng/ml (Standard Deviation 16).
What this means
The posted results provide data on changes in several biomarkers and adherence rates in a small study investigating time-restricted eating. The time-restricted feeding group demonstrated a slightly lower mean change in plasma AGE levels compared to the control group, and a slightly higher mean change in sRAGE levels. Adherence to the eating recommendations was also higher in the time-restricted feeding group. For IGF-1, the time-restricted feeding group showed a higher mean change compared to control. Without statistical analyses or larger trials, the clinical significance of these biomarker changes for breast cancer risk or pre-diabetes management cannot be definitively determined from these results alone. However, the adherence data suggests that time-restricted eating is feasible for participants.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05038137, titled "Time Restricted Eating on Cancer Risk", were posted on 2025-07-04 on clinicaltrials.gov.