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Time Restricted Eating (TRE) Schedule for Endometrial Cancer (TIMESPAN Trial)

N/A

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14)

Awards & highlights

TIMESPAN Trial Summary

This trialwill study how a diet of time-restricted eating affects metabolic health and cancer prevention in Native Hawaiian/Pacific Islander women.

TIMESPAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (visit 1), visit 2 (week 2), visit 3 (week 6), visit 5 (week 14) 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

+3 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

TIMESPAN Trial Design

2Treatment groups

Experimental Treatment

Active Control

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

For 8 weeks out of the 14-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 calories-containing beverages within an 8 to 10-hour period that fits their schedule. The fasting period will ramp up during the first week (Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day).

Group II: Control ScheduleActive Control1 Intervention

For 4 weeks out of the 14-week randomized dietary crossover study, women will receive prepared frozen lunch and dinner meals, and a standardized breakfast and snacks menu. All meals and snacks will be culturally competent, and meal plans will be individualized to meet weight maintenance energy requirements.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating (TRE) Schedule

2021

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,613 Total Patients Enrolled

3 Trials studying Endometrial Cancer

83 Patients Enrolled for Endometrial Cancer

National Center for Advancing Translational Sciences (NCATS)NIH

320 Previous Clinical Trials

401,713 Total Patients Enrolled

1 Trials studying Endometrial Cancer

150 Patients Enrolled for Endometrial Cancer

Mary Playdon, PhD, MPHPrincipal Investigator - University of Utah

University of Utah

1 Previous Clinical Trials

15 Total Patients Enrolled

1 Trials studying Endometrial Cancer

15 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

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

Is there still an opportunity for individuals to join this clinical experiment?

"Indeed, the information hosted on clinicaltrials.gov states that this ongoing medical study is actively enrolling patients. This research initiative was first publicized on February 18th 2021 and has most recently been updated on November 3rd 2022; the project aims to recruit 30 individuals from a single site."

Answered by AI

How many participants are engaged in this experiment?

"Confirmatively, the information on clinicaltrials.gov reveals that this research initiative is currently searching for individuals to partake in it. It was initially posted on February 18th 2021 and last updated November 3rd 2022. The study necessitates 30 volunteers from a single location."

Answered by AI

What key goals is this research endeavor aiming to achieve?

"The primary outcome measure of this experiment, assessed between the initial visit and Week 14, is the proportion of meals delivered on schedule. As secondary objectives, researchers will monitor changes in HOMA-IR (assessed via blood draw), fasting glucose levels (also captured with a sample of blood) and high sensitivity C-reactive protein concentrations (again with a small amount of collected plasma)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer

Mary Playdon 2021. "Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04763902.