Time-restricted Eating in Survivors Trial

NCT ID: NCT05639829

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2021-07-28

Brief Summary

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Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.

Detailed Description

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Conditions

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Cancer, Breast

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Weekday time-restricted eating

The intervention consisted of 8 weeks of ad libitum TRE with a 12-8 pm 8-hour eating window on weekdays. Participants received instructions to only consume water, black coffee, or black tea from 8 pm to 12 pm on weekdays and during the weekend, where there were no restrictions on eating timing. No other dietary or physical activity instructions were given.

Group Type EXPERIMENTAL

Time-restricted eating

Intervention Type BEHAVIORAL

Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period

Interventions

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Time-restricted eating

Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period

Intervention Type BEHAVIORAL

Other Intervention Names

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intermittent fasting

Eligibility Criteria

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Inclusion Criteria

* history of early-stage (I-III) breast cancer
* completed anthracycline-based chemotherapy 1-6 years earlier
* aged ≥60 years
* had a body mass index (BMI) \>25 kg/m2

Exclusion Criteria

* taking lipid, glucose, or weight-lowering medications
* contraindications to maximal exercise testing or research MRI
* unstable thyroid disorder
* self-reported history of an eating disorder
* self-reported diagnosis of type 1 or 2 diabetes
* weight loss of ≥15 lbs in previous 3 months
* working night shifts
* could not provide consent in English
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Edmonton Clinic Health Academy

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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HREBA.CC-20-0077

Identifier Type: -

Identifier Source: org_study_id

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