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COMPLETED
NCT04763902
NA

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

Sponsor: University of Utah

View on ClinicalTrials.gov

Summary

The long-term goal of this study is to determine the efficacy of time restricted eating (TRE) for improving metabolic health and preventing endometrial cancer. The primary objective of the protocol is to conduct a 14-week two-arm randomized crossover trial of a dietary intervention to evaluate the feasibility, fidelity and preliminary acceptability of a TRE intervention among Native Hawaiian/Pacific Islander women at risk for developing endometrial cancer, and to provide proof of principle that TRE can improve metabolic health in this population.

Official title: Feasibility and Acceptability of Time Restricted Eating (TRE) Among Native Hawaiian/Pacific Islander Women at Risk for Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2021-02-18

Completion Date

2022-09-30

Last Updated

2026-07-29

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Time Restricted Eating (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. They will be asked to maintain their regular sleep and physical activity schedule. Fasting period will ramp up during the first week (e.g., 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 feeding period at the same time each day. They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing \< 4 kcal/serving) to increase compliance. All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.

BEHAVIORAL

Control Schedule

Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu. All meals and the breakfast/snack menu will be designed to be culturally competent. The meal plans will be individualized to meet weight maintenance energy requirements.

Locations (1)

Huntsman Cancer Institute

Salt Lake City, Utah, United States