Cancer, BreastTESTNCT05639829
Time-restricted Eating in Survivors Trial
A study testing Time-restricted eating in people with Cancer, Breast, run by University of Alberta at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Cancer, Breast
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 5 Aug 2020to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer, Breast
- Being tested
- Time-restricted eating
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Also called intermittent fasting
Restriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period
| Study group | Role | What they receive |
|---|---|---|
| Weekday time-restricted eating | Experimental | 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. Receives: Behavioral: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Framingham 10-year cardiovascular risk score (%)
Calculated using the Canadian Cardiovascular scoring system
Measured: 8 weeks
Secondary outcomes (15)
Visceral adipose tissue
measured via magnetic resonance fat-water separation imaging
Measured: 8 weeks
Thigh adipose tissue fraction
Relative measure of amount of inter+intra muscular adipose tissue within the thigh muscle measured via magnetic resonance fat-water separation imaging
Measured: 8 weeks
Liver adipose tissue fraction
Relative measure of amount of adipose tissue within the liver
Measured: 8 weeks
Cardiorespiratory fitness
Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test
Measured: 8 weeks
Resting energy expenditure
Collected via metabolic cart in supine resting position after overnight fast
Measured: 8 weeks
Respiratory quotient
Collected via metabolic cart in supine resting position after overnight fast
Measured: 8 weeks
Lipid profile
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Measured: 8 weeks
Hemoglobin A1c
Collected via analysis of blood sample by Lifelabs commercial laboratory
Measured: 8 weeks
Waist circumference
measured as the average of two measurements to the nearest 0.5 cm.
Measured: 8 weeks
Fasting glucose
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Measured: 8 weeks
Fasting insulin
Collected via analysis of fasting blood sample by Lifelabs commercial laboratory
Measured: 8 weeks
Resting systolic and diastolic blood pressure
measured as the average of two measurements 60 seconds apart following 5-10 minutes of supine rest using an automated device
Measured: 8 weeks
Body mass
measured by physicians scale after overnight fast
Measured: 8 weeks
Whole-body fat mass
estimated using8-point bioelectric impedance (Seca)
Measured: 8 weeks
Whole-body fat-free mass
estimated using8-point bioelectric impedance (Seca)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start5 Aug 2020
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639829
- Sponsor's protocol ID
- HREBA.CC-20-0077
- Acronym
- TEST
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating in Survivors Trial
- ClinicalTrials.gov ID
- NCT05639829
- Acronym / sponsor ID
- TEST / HREBA.CC-20-0077
- Conditions
- Cancer, Breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekday time-restricted eating | Experimental | Behavioral: Time-restricted eatingThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingAlso: intermittent fastingRestriction of calorie intake to an 8-hour window, with water only fasting in the remaining 16 hours of the 24-hour period | Behavioural | Weekday time-restricted eating |
Primary outcome
Framingham 10-year cardiovascular risk score (%)
Time frame: 8 weeks
Calculated using the Canadian Cardiovascular scoring system
15 secondary outcomes
Visceral adipose tissue
Time frame: 8 weeks
Thigh adipose tissue fraction
Time frame: 8 weeks
Liver adipose tissue fraction
Time frame: 8 weeks
Cardiorespiratory fitness
Time frame: 8 weeks
Resting energy expenditure
Time frame: 8 weeks
Respiratory quotient
Time frame: 8 weeks
Lipid profile
Time frame: 8 weeks
Hemoglobin A1c
Time frame: 8 weeks
Waist circumference
Time frame: 8 weeks
Fasting glucose
Time frame: 8 weeks
Fasting insulin
Time frame: 8 weeks
Resting systolic and diastolic blood pressure
Time frame: 8 weeks
Body mass
Time frame: 8 weeks
Whole-body fat mass
Time frame: 8 weeks
Whole-body fat-free mass
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Cancer, Breast, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Framingham 10-year cardiovascular risk score (%) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.