Time-restricted Eating in Survivors Trial (TEST)

April 11, 2023 updated by: University of Alberta
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Edmonton Clinic Health Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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
Other Names:
  • intermittent fasting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Framingham 10-year cardiovascular risk score (%)
Time Frame: 8 weeks
Calculated using the Canadian Cardiovascular scoring system
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visceral adipose tissue
Time Frame: 8 weeks
measured via magnetic resonance fat-water separation imaging
8 weeks
Thigh adipose tissue fraction
Time Frame: 8 weeks
Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging
8 weeks
Liver adipose tissue fraction
Time Frame: 8 weeks
Relative measure of amount of adipose tissue within the liver
8 weeks
Cardiorespiratory fitness
Time Frame: 8 weeks
Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test
8 weeks
Resting energy expenditure
Time Frame: 8 weeks
Collected via metabolic cart in supine resting position after overnight fast
8 weeks
Respiratory quotient
Time Frame: 8 weeks
Collected via metabolic cart in supine resting position after overnight fast
8 weeks
Lipid profile
Time Frame: 8 weeks
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
8 weeks
Hemoglobin A1c
Time Frame: 8 weeks
Collected via analysis of blood sample by Lifelabs commercial laboratory
8 weeks
Waist circumference
Time Frame: 8 weeks
measured as the average of two measurements to the nearest 0.5 cm.
8 weeks
Fasting glucose
Time Frame: 8 weeks
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
8 weeks
Fasting insulin
Time Frame: 8 weeks
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
8 weeks
Resting systolic and diastolic blood pressure
Time Frame: 8 weeks
measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device
8 weeks
Body mass
Time Frame: 8 weeks
measured by physicians scale after overnight fast
8 weeks
Whole-body fat mass
Time Frame: 8 weeks
estimated using8-point bioelectric impedance (Seca)
8 weeks
Whole-body fat-free mass
Time Frame: 8 weeks
estimated using8-point bioelectric impedance (Seca)
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: 8 weeks
Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software
8 weeks
Activity
Time Frame: Change between measurement at baseline and 8 weeks
24-hour Measured via Sensewear Pro accelerometer worn on the arm for 3 consecutive weekdays
Change between measurement at baseline and 8 weeks
Adherence to intervention
Time Frame: Ongoing for duration of intervention
Collected via participant responses to automated text messages asking participants to self-report the time they started and stopped eating each day. Calculated as the % of prescribed days to follow the intervention where participant reported performing a 16 hour or longer fast.
Ongoing for duration of intervention
Participant acceptability
Time Frame: 8 weeks
assessed by a researcher-developed end of study questionnaire as: 1) a subjective difficulty rating for following TRE on a scale of 1-10 and 2) rating the dietitian and support calls as 'very helpful' or 'somewhat helpful' on a 5-point Likert scale (other options were 'neutral,' 'somewhat helpful,' and 'unhelpful')
8 weeks
Intervention fidelity
Time Frame: 8 weeks
determined as completion rates of the intervention components (registered dietitian consult call, the three support calls, and response rate to the text messages)
8 weeks
Intervention sustainability
Time Frame: 1 month post intervention
Rate of continuing to follow TRE one-month post-intervention completion (without further support or instructions) collected by phone follow-up
1 month post intervention
Intervention sustainability confidence
Time Frame: 8 weeks
Average subjective rating of confidence, on 0-100% scale, in ability to follow TRE for one year or longer
8 weeks
Intervention delivery cost
Time Frame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Estimated as average time spent by personnel on intervention delivery multiplied by the hourly rate for that personnel
Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Symptoms
Time Frame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Collected at each of the support phone calls at weeks 1, 3, 6 of the intervention. The research coordinator asked participants if they experienced any symptoms on a pre-determined list or any additional symptoms. Symptoms were only recorded if the participant reported that they were related to the intervention or were unsure if they were related. Symptoms attributed to other life events (i.e., heat wave, stress at work) were not recorded.
Through study completion, lasting 12-24 weeks depending on chemotherapy protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HREBA.CC-20-0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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