Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783467
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2021-02-18
Brief Title:
Time Restricted Eating TRE Among Endometrial Cancer Patients
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Feasibility and Acceptability of Time Restricted Eating TRE Among Endometrial Cancer Patients the TREND Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREND
Brief Summary:
The long-term goal of this study is to determine the efficacy of Time Restricted Eating TRE for improving metabolic health preventing cardiometabolic comorbidities and improving prognosis after endometrial cancer diagnosis The primary objective of the protocol is to conduct a 16-week randomized dietary crossover study to evaluate the feasibility fidelity and preliminary acceptability of TRE among endometrial cancer patients and to provide proof of principle that TRE can improve metabolic health in this population
Detailed Description:
Enrollment The study team will aim to recruit 15 endometrial cancer patients seen at the Huntsman Cancer Hospital Clinics Consent may be completed via phoneemail or in-person with the study clinical coordinator
Dietary Intervention Participants who are consented into the study will participate in a 16-week randomized dietary crossover intervention The dietary intervention includes 5 study visits and features a baseline visit 2-week run-in period 4-week control diet schedule with prepared frozen meals provided to participants 4-week washout period and a 6-week 8 to 10-hour Time Restricted Eating TRE protocol meal provision with 8 to 10-hour eating and 14 to 16-hour fasting periods Women will be randomized to either control or TRE then crossover to the other condition For the control schedule women will receive frozen lunch and dinner meals and be provided with a standardized breakfast and snacks menu and there are no restrictions on timing of eating For the TRE schedule women will receive prepared frozen lunch and dinner meals as per the control schedule but will be asked to consume daily meals snacks and calorie-containing beverages within an 8 to 10-hour period that fits their schedule Fasting period will ramp up during the first week eg Days 1-3 12-14 h per day Days 4-6 14-16 h per day Days 7 16 h per day Women will be asked to schedule the eating period at the same time each day
Study Visits and Assessments Women will attend in-person study visits at the Huntsman Cancer Institute Center for Health Outcomes and Population Equity HOPE
Baseline Visit Visit 1 The clinical coordinator will obtain consent from the participant Once consented women will complete questionnaires to capture information on clinical and demographic factors and chronotype Height will be measured using stadiometer weight will be measured using calibrated scales waist circumference with measuring tape and blood pressure BP using an electronic BP monitor Participants may take home questionnaires with mailer to complete at home
2-Week Run-In Period The purpose of the run-in period is to record womens usual times of eating episodes and appetite while following their habitual diet Appetite will be measured using the MyCircacianClock mCC phone app that has the capability to sample subjects current behaviors and experiences in real time in their natural environment Women will complete 3 x 24-hour dietary recalls on non-consecutive days ASA-24 and a physical activity recall ACT24 available online or phone app or via telephone conference with the clinical coordinator Sleep and activity will also be objectively measured for 7-days using an Actiwatch
Visit 2 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured
Control OR TRE Schedules The participants will be expected to follow their randomized schedule for meal timing During these schedules for both study groups participants will record timing of eating episodes daily using the MyCircadianClock app complete 3 x 24-hour recalls ASA24 1 x ACT24 activity recall and 7-days of sleepphysical activity will be objectively measured via Actiwatch
Visit 3 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured
4-Week Washout Period During the washout period women can return to their usual lifestyle Meals will not be provided during this time
Visit 4 Visit 4 will include a telephone call only to discuss the next study phase and schedule meal provision
Visit 5 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured An exit interview may occur in person or via phonevideo conference to ask questions about how well the intervention was tolerated and allow participants to provide feedback
Follow-Up Approximately 6-months after consent and roughly 10 weeks after the end of the dietary intervention participants will be asked to complete a follow-up questionnaire
Dietary Intervention Participants who are consented into the study will participate in a 16-week randomized dietary crossover intervention The dietary intervention includes 5 study visits and features a baseline visit 2-week run-in period 4-week control diet schedule with prepared frozen meals provided to participants 4-week washout period and a 6-week 8 to 10-hour Time Restricted Eating TRE protocol meal provision with 8 to 10-hour eating and 14 to 16-hour fasting periods Women will be randomized to either control or TRE then crossover to the other condition For the control schedule women will receive frozen lunch and dinner meals and be provided with a standardized breakfast and snacks menu and there are no restrictions on timing of eating For the TRE schedule women will receive prepared frozen lunch and dinner meals as per the control schedule but will be asked to consume daily meals snacks and calorie-containing beverages within an 8 to 10-hour period that fits their schedule Fasting period will ramp up during the first week eg Days 1-3 12-14 h per day Days 4-6 14-16 h per day Days 7 16 h per day Women will be asked to schedule the eating period at the same time each day
Study Visits and Assessments Women will attend in-person study visits at the Huntsman Cancer Institute Center for Health Outcomes and Population Equity HOPE
Baseline Visit Visit 1 The clinical coordinator will obtain consent from the participant Once consented women will complete questionnaires to capture information on clinical and demographic factors and chronotype Height will be measured using stadiometer weight will be measured using calibrated scales waist circumference with measuring tape and blood pressure BP using an electronic BP monitor Participants may take home questionnaires with mailer to complete at home
2-Week Run-In Period The purpose of the run-in period is to record womens usual times of eating episodes and appetite while following their habitual diet Appetite will be measured using the MyCircacianClock mCC phone app that has the capability to sample subjects current behaviors and experiences in real time in their natural environment Women will complete 3 x 24-hour dietary recalls on non-consecutive days ASA-24 and a physical activity recall ACT24 available online or phone app or via telephone conference with the clinical coordinator Sleep and activity will also be objectively measured for 7-days using an Actiwatch
Visit 2 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured
Control OR TRE Schedules The participants will be expected to follow their randomized schedule for meal timing During these schedules for both study groups participants will record timing of eating episodes daily using the MyCircadianClock app complete 3 x 24-hour recalls ASA24 1 x ACT24 activity recall and 7-days of sleepphysical activity will be objectively measured via Actiwatch
Visit 3 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured
4-Week Washout Period During the washout period women can return to their usual lifestyle Meals will not be provided during this time
Visit 4 Visit 4 will include a telephone call only to discuss the next study phase and schedule meal provision
Visit 5 Women will provide fasting blood and stool samples Weight waist circumference and blood pressure will be measured An exit interview may occur in person or via phonevideo conference to ask questions about how well the intervention was tolerated and allow participants to provide feedback
Follow-Up Approximately 6-months after consent and roughly 10 weeks after the end of the dietary intervention participants will be asked to complete a follow-up questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None