Trial Outcomes & Findings for Time Restricted Eating on Cancer Risk (NCT NCT05038137)
NCT ID: NCT05038137
Last Updated: 2026-01-09
Results Overview
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.
COMPLETED
NA
29 participants
Visit 1 (0 weeks), Visit 2 (14 weeks)
2026-01-09
Participant Flow
Participant milestones
| Measure |
Time Restricted Feeding
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM for 12 weeks.
|
Control
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Time Restricted Eating on Cancer Risk
Baseline characteristics by cohort
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 6.0 • n=8 Participants
|
58.5 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 5.9 • n=15 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=8 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=8 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=8 Participants
|
14 participants
n=7 Participants
|
29 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
Visit 1 (0 weeks)
|
5.82 ng/mL
Interval 5.49 to 6.15
|
6.38 ng/mL
Interval 5.71 to 7.05
|
|
Change in Advanced Glycation End Products (AGE) as Assessed by Plasma
Visit 2 (14 weeks)
|
5.82 ng/mL
Interval 5.45 to 6.2
|
6.40 ng/mL
Interval 5.88 to 6.93
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Change in sRAGE(Soluble Receptor for AGE) Levels
Visit 1 (0 weeks)
|
2.77 ng/mL
Interval 2.63 to 2.9
|
2.65 ng/mL
Interval 2.51 to 2.79
|
|
Change in sRAGE(Soluble Receptor for AGE) Levels
Visit 2 (14 weeks)
|
2.64 ng/mL
Interval 2.47 to 2.8
|
2.58 ng/mL
Interval 2.42 to 2.75
|
PRIMARY outcome
Timeframe: Visit 1 (0 weeks), Visit 2 (14 weeks)Percentage of dietary visits that participant reported compliance with randomized eating period.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Assess Feasibility and Adherence to Time Period of Eating Recommendations in Both Study Groups.
|
90.1 Percentage of visits
Interval 0.0 to 100.0
|
83.3 Percentage of visits
Interval 14.3 to 100.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Change in Fasting Insulin-like Growth Factor-1 (IGF-1) Levels
|
2.5 ng/ml
Standard Deviation 24
|
.01 ng/ml
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Change in Fasting Insulin Levels
|
-0.6 µU/ml
Interval -9.3 to 2.7
|
1.0 µU/ml
Interval 0.3 to 5.3
|
SECONDARY outcome
Timeframe: Visit 1 (0 weeks), Visit 2 (14 weeks)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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Difference in Glasgow Prognostic Scoring System
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Change in 24 Hour Urinary AGE Levels
Visit 1 (0 weeks)
|
6.51 ng/mL
Interval 6.1 to 6.92
|
6.69 ng/mL
Interval 6.18 to 7.2
|
|
Change in 24 Hour Urinary AGE Levels
Visit 2 (14 weeks)
|
5.82 ng/mL
Interval 5.33 to 6.31
|
6.02 ng/mL
Interval 5.55 to 6.49
|
SECONDARY outcome
Timeframe: Visit 1 (0 weeks), Visit 2 (14 weeks)Percentage of expected visits attended.
Outcome measures
| Measure |
Time Restricted Feeding
n=15 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Adherence to Virtual Visit With Psychologist or Dietician
|
97.5 Percentage
Interval 75.0 to 100.0
|
98.2 Percentage
Interval 87.5 to 100.0
|
SECONDARY outcome
Timeframe: Visit 1 (0 weeks), Visit 2 (14 weeks)Proportion of dietary visits where participants reported compliance with randomized eating period, assessed through self-report during virtual visits and via food photography/annotated entries.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Visit 1 (0 weeks), Visit 2 (14 weeks)Population: All randomized participants who completed both baseline and end-of-study sleep diaries were included in the analysis. Stability was defined as no change in chronotype classification between Visit 1 and Visit 2.
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.
Outcome measures
| Measure |
Time Restricted Feeding
n=13 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=14 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Percentage of Participants With Stable Chronotype Between Baseline and End of Study
|
0.923 % of participants with stable chronotype
Interval 0.655 to 0.992
|
0.857 % of participants with stable chronotype
Interval 0.603 to 0.96
|
SECONDARY outcome
Timeframe: Final 14 days of intervention period (Visit 2).Population: All randomized participants who completed CGM monitoring during the final 14 days of the intervention period were included in the analysis. Mean glucose was calculated as the average of all CGM readings during this period.
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).
Outcome measures
| Measure |
Time Restricted Feeding
n=13 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=11 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Mean Glucose at Visit 2
|
113.8 mg/dL
Interval 108.8 to 118.8
|
101.9 mg/dL
Interval 96.0 to 107.8
|
SECONDARY outcome
Timeframe: Visit 2 (14 weeks)GMI percentage derived from CGM data collected during the final 14 days of the intervention period (Visit 2).
Outcome measures
| Measure |
Time Restricted Feeding
n=13 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=11 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Glucose Management Indicator (GMI) at Visit 2
|
6 percentage
Interval 5.9 to 6.2
|
5.8 percentage
Interval 5.6 to 5.9
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Time Restricted Feeding
n=13 Participants
daily eating period of 8 hours, before 8 PM
Time restricted feeding: Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
|
Control
n=11 Participants
daily eating period ≥ 12 hours
Control: Participants will have a daily eating period equal to or greater than 12 hours.
|
|---|---|---|
|
Glucose Variability at Visit 2
|
18 percentage
Interval 16.0 to 20.0
|
17.6 percentage
Interval 14.8 to 20.5
|
Adverse Events
Time Restricted Feeding
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place