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Time-restricted Eating in Survivors Trial (TEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639829
Recruitment Status : Completed
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief 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 three support phone calls.

Condition or disease Intervention/treatment Phase
Cancer, Breast Behavioral: Time-restricted eating Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Time-restricted Eating in Survivors Trial
Actual Study Start Date : August 5, 2020
Actual Primary Completion Date : July 28, 2021
Actual Study Completion Date : July 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: intermittent fasting




Primary Outcome Measures :
  1. Framingham 10-year cardiovascular risk score (%) [ Time Frame: 8 weeks ]
    Calculated using the Canadian Cardiovascular scoring system


Secondary Outcome Measures :
  1. Visceral adipose tissue [ Time Frame: 8 weeks ]
    measured via magnetic resonance fat-water separation imaging

  2. 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

  3. Liver adipose tissue fraction [ Time Frame: 8 weeks ]
    Relative measure of amount of adipose tissue within the liver

  4. Cardiorespiratory fitness [ Time Frame: 8 weeks ]
    Measured as peak volume of oxygen consumed collected with a cycle erogmeter exercise test

  5. Resting energy expenditure [ Time Frame: 8 weeks ]
    Collected via metabolic cart in supine resting position after overnight fast

  6. Respiratory quotient [ Time Frame: 8 weeks ]
    Collected via metabolic cart in supine resting position after overnight fast

  7. Lipid profile [ Time Frame: 8 weeks ]
    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  8. Hemoglobin A1c [ Time Frame: 8 weeks ]
    Collected via analysis of blood sample by Lifelabs commercial laboratory

  9. Waist circumference [ Time Frame: 8 weeks ]
    measured as the average of two measurements to the nearest 0.5 cm.

  10. Fasting glucose [ Time Frame: 8 weeks ]
    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  11. Fasting insulin [ Time Frame: 8 weeks ]
    Collected via analysis of fasting blood sample by Lifelabs commercial laboratory

  12. 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

  13. Body mass [ Time Frame: 8 weeks ]
    measured by physicians scale after overnight fast

  14. Whole-body fat mass [ Time Frame: 8 weeks ]
    estimated using8-point bioelectric impedance (Seca)

  15. Whole-body fat-free mass [ Time Frame: 8 weeks ]
    estimated using8-point bioelectric impedance (Seca)


Other Outcome Measures:
  1. Dietary intake [ Time Frame: 8 weeks ]
    Measured via diet records on 3 consecutive weekdays that were analyzed via Food Processor Nutrition Analysis Software

  2. 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

  3. 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.

  4. 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')

  5. 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)

  6. 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

  7. 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. 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

  9. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639829


Locations
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Canada, Alberta
Edmonton Clinic Health Academy
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT05639829    
Other Study ID Numbers: HREBA.CC-20-0077
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases