Adults 40 to 67, female only, with Pre-diabetes or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Advanced Glycation End Products (AGE) as Assessed by PlasmaPrimary· Visit 1 (0 weeks), Visit 2 (14 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.
Visit 1 (0 weeks)
Group
Value
95% CI
Time Restricted Feeding
5.82
5.49 – 6.15
Control
6.38
5.71 – 7.05
Visit 2 (14 weeks)
Group
Value
95% CI
Time Restricted Feeding
5.82
5.45 – 6.20
Control
6.40
5.88 – 6.93
Change in sRAGE(Soluble Receptor for AGE) LevelsPrimary· Visit 1 (0 weeks), Visit 2 (14 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.
Visit 1 (0 weeks)
Group
Value
95% CI
Time Restricted Feeding
2.77
2.63 – 2.90
Control
2.65
2.51 – 2.79
Visit 2 (14 weeks)
Group
Value
95% CI
Time Restricted Feeding
2.64
2.47 – 2.80
Control
2.58
2.42 – 2.75
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.Primary· Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of dietary visits that participant reported compliance with randomized eating period.
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.
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.
The Glasgow Prognostic Score (GPS) reflects systemic inflammatory process. 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.
Group
Value
95% CI
Time Restricted Feeding
0
0 – 0
Control
0
0 – 0
Change in 24 Hour Urinary AGE LevelsSecondary· Visit 1 (0 weeks), Visit 2 (14 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.
Visit 1 (0 weeks)
Group
Value
95% CI
Time Restricted Feeding
6.51
6.10 – 6.92
Control
6.69
6.18 – 7.20
Visit 2 (14 weeks)
Group
Value
95% CI
Time Restricted Feeding
5.82
5.33 – 6.31
Control
6.02
5.55 – 6.49
Adherence to Virtual Visit With Psychologist or DieticianSecondary· Visit 1 (0 weeks), Visit 2 (14 weeks)
Percentage of expected visits attended.
Group
Value
95% CI
Time Restricted Feeding
97.5
75 – 100
Control
98.2
87.5 – 100
Percentage of Participants With Stable Chronotype Between Baseline and End of StudySecondary· Visit 1 (0 weeks), Visit 2 (14 weeks)
Stability in chronotype (normal, delayed, or advanced) was assessed using 2-week sleep diaries at baseline and end of study. Stability was defined as no change in chronotype classification between Visit 1 and Visit 2.
Group
Value
95% CI
Time Restricted Feeding
0.923
0.655 – 0.992
Control
0.857
0.603 – 0.960
Mean Glucose at Visit 2Secondary· Final 14 days of intervention period (Visit 2).
Mean glucose level calculated as the average of continuous glucose monitoring (CGM) data collected during the final 14 days of the intervention period (Visit 2).
GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2).
Group
Value
95% CI
Time Restricted Feeding
6
5.9 – 6.2
Control
5.8
5.6 – 5.9
Glucose Variability at Visit 2Secondary· Visit 2 (14 weeks)
Coefficient of variation of glucose levels derived from CGM data during the final 14 days of the intervention period (Visit 2).
Group
Value
95% CI
Time Restricted Feeding
18
16 – 20
Control
17.6
14.8 – 20.5
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05593939 — Slow Age: Interventions to Slow Aging in Humans
· Phase 2
· completed
NCT05756868 — The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
· NA
· completed
NCT05717127 — Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
· NA
· completed
NCT04988230 — Time Restricted Feeding on Nonalcoholic Fatty Liver Disease ( TREATY-FLD )：a 12-month Follow-up Study
· NA
· completed
NCT04627688 — Optimization of Diet Before Surgery (OptiSurg)
· NA
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 9 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05038137.