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Time Restricted Eating for Endometrial Cancer (TREND Trial)

N/A

Recruiting

Led By Mary Playdon, PhD, MPH

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with endometrial cancer (any stage)

Females aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 1), visit 2 (week 2), visit 3 (week 6 or week 8), visit 5 (week 16)

Awards & highlights

TREND Trial Summary

This trialwill test if Time Restricted Eating (TRE) can improve metabolic health and reduce cardiometabolic disease in endometrial cancer patients.

Who is the study for?

This trial is for women over 18 who've been diagnosed with endometrial cancer, are at least three months post-cancer surgery or treatment, and have had a stable weight recently. Participants must be clinically overweight or obese and able to use a cell phone app during the day. It's not for those unable to consent, read/write in English, on special diets, insulin-dependent diabetics, night shift workers, or restricted from using a cell phone.Check my eligibility

What is being tested?

The study is testing Time Restricted Eating (TRE) as a way to improve metabolic health after an endometrial cancer diagnosis. Over 16 weeks, participants will follow TRE schedules in a crossover design—meaning they'll switch between TRE and their usual eating pattern—to see if it's feasible and beneficial.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include hunger outside of eating windows and potential changes in energy levels. Individual experiences may vary based on personal health status.

TREND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with endometrial cancer.

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I am a woman aged 18 or older.

TREND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 1), visit 2 (week 2), visit 3 (week 6 or week 8), visit 5 (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 1), visit 2 (week 2), visit 3 (week 6 or week 8), visit 5 (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 1), visit 2 (week 2), visit 3 (week 6 or week 8), visit 5 (week 16) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Attrition as a Function of Time

Fidelity of Time Restricted Eating (TRE) Intervention

Number of TRE-Adherent Days per Week

+2 more

Secondary outcome measures

Change in BMI assessed via height and weight

Change in HDL-cholesterol assessed via blood draw

Change in HOMA-IR assessed via blood draw

+6 more

TREND Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time Restricted Eating (TRE) ScheduleExperimental Treatment1 Intervention

For 6-weeks out of the 16-week randomized dietary crossover study, 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. The meal plans will be individualized to meet weight maintenance energy requirements.

Group II: Control ScheduleActive Control1 Intervention

For 4 weeks out of the 16-week randomized dietary crossover study, women will receive frozen lunch and dinner meals, and a standardized breakfast and snacks menu. The meal plans will be individualized to meet weight maintenance energy requirements. There are no restrictions on timing of eating.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating (TRE) Schedule

2021

N/A

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,674 Total Patients Enrolled

2 Trials studying Endometrial Cancer

68 Patients Enrolled for Endometrial Cancer

Mary Playdon, PhD, MPHPrincipal InvestigatorUniversity of Utah

1 Previous Clinical Trials

17 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being allocated to this clinical investigation?

"Affirmative, according to clinicaltrials.gov the trial is actively recruiting subjects and was posted on October 7th 2021 before being updated most recently on November 3rd 2022. 15 individuals are required for this study which will take place at a single location."

Answered by AI

What aims has this scientific research set out to accomplish?

"The primary goal of this medical study, with measurements taken from the beginning to Week 16, is to identify the proportion of women who agree to participate. Secondary objectives involve tracking alterations in fasting blood glucose (blood sample), electronic blood pressure monitor readings and HDL-cholesterol levels (also through a small sample)."

Answered by AI

Is enrollment still open for this research project?

"Affirmative. The information hosted on clinicaltrials.gov specifies that the trial is open for recruitment; it was initially published on October 7th 2021 and its details were last updated November 3rd 2022. There are 15 available spots to be filled in total, all at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time Restricted Eating (TRE) Among Endometrial Cancer Patients

Mary Playdon 2021. "Time Restricted Eating (TRE) Among Endometrial Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04783467.