Trial Outcomes & Findings for Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study (NCT NCT04243512)

Last Updated: 2023-05-11

Results Overview

Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

14 days

Results posted on

2023-05-11

Participant milestones
Measure	Time-restricted Eating Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. Time-restricted eating: Restrict food and beverage intake (except water) to a 10-hour window
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Withdrawal data not reported

Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study

Baseline characteristics by cohort
Measure	Time-restricted Eating n=39 Participants Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. Time-restricted eating: Restrict food and beverage intake (except water) to a 10-hour window
Age, Continuous	61.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

Timeframe: 14 days

Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern

Outcome measures
Measure	Time-restricted Eating n=36 Participants Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. Time-restricted eating: Restrict food and beverage intake (except water) to a 10-hour window
Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern	90.1 percent of days Interval 43.0 to 100.0

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Time-restricted Eating n=39 participants at risk Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. Time-restricted eating: Restrict food and beverage intake (except water) to a 10-hour window
General disorders headache	2.6% 1/39 • Number of events 1 • 2 weeks
General disorders insomnia	2.6% 1/39 • Number of events 1 • 2 weeks

University of Maryland Baltimore

Phone: 410-706-5961