eTRE (Early Time Restricted Eating)NCT05704699
Effect of Early Eating and Stair Climbing on Body Composition
A study testing eTRE and eTRE with BISC in people with eTRE (Early Time Restricted Eating) and eTRE With BISC (Brief Intense Stair Climbing), run by Western University, Canada at 1 site in Canada.
Trial summary
To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- eTRE (Early Time Restricted Eating), eTRE With BISC (Brief Intense Stair Climbing)
- What is being tested?
- eTRE and eTRE with BISC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 31 Dec 2023
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- sedentary- lightly physically active (<7,500 steps daily)
- BMI > 25 • 18-39 years old
Who cannot join
- Have diabetes (self-reported)
- Have history of smoking (self-reported)
- Have history of cardiovascular disease (self-reported)
- Have BMI of <24.9
- Are pregnant or become pregnant during the study (self-reported)
- Take medication for weight loss (self-reported)
- Physical activity level > 7500 steps/day
- Unstable weight for 3 months prior to commencement of study (>4kg weight loss/gain) • Employed in a shift work position
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Laboratory, Western University
London, Ontario, N6A3K7
About this study
Official title: Effect of Early Time Restricted Eating and Brief Intense Stair Climbing on Body Composition
To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against eTRE with Brief Intense Stair Climbing (BISC) directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.
- Being tested
- eTRE, eTRE with BISC
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eTREBehavioural
eating between 0800h and 1600h daily
eTRE with BISCBehavioural
eating between 0800h and 1600h daily and completing 3 sessions of BISC per week of study duration
| Study group | Role | What they receive |
|---|---|---|
| eTRE | Experimental | participants allocated to this group are required to consume food during 0800h and 1600h. Receives: Behavioral: eTRE |
| eTRE with BISC | Active comparator | participants allocated to this group are required to consume food during 0800h and 1600h as well as complete 3 sessions of BISC per week. Receives: Behavioral: eTRE with BISC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Composition
fat mass vs. fat-free mass via BodPod
Measured: less than 5 mins
Secondary outcomes (3)
upper body strength test
3-rep max bench press
Measured: < 15 mins
lower body strength test
3-rep max leg press
Measured: < 15 mins
health related quality of life questionnaire
subjective feelings of well-being per participant
Measured: < 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for eTRE (Early Time Restricted Eating)Studies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704699
- Sponsor's protocol ID
- 122046
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Time Restricted Eating and Brief Intense Stair Climbing on Body Composition
- ClinicalTrials.gov ID
- NCT05704699
- Acronym / sponsor ID
- 122046
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jan 2023 (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.
To our knowledge, as of this day there are only four studies which examined the effects of eTRE with a duration of 12 weeks. There are no studies that examined this phenomenon beyond 12 weeks, one study that lasted five weeks and four studies that lasted 4 weeks or less, some even days. The four studies that lasted 12 weeks in duration all have opportunities to improve upon, which will be discussed here. The first study performed by Gabel et al., focused primarily on measuring body weight, not body composition in older adults. The eating window also began later in the morning at 1000h and finished at 1800h. There also was no restriction on participants consuming caffeine during the fasting window. The second study conducted by Gasmi et al., was focused on strictly older male participants that were active and healthy, again, without measuring body composition. The third study conducted by Wilkinson et al., did not measure body composition and the eating window lasted 10 hours instead of 8. The fourth study performed by Chow et al., examined eTRE with adults aged 45+/-12 years old and did not mention any exclusion criteria based upon physical activity levels or restrictions on caffeine/artificial sweetener intake during the fasting window. Furthermore, none of the studies mentioned above examined eTRE against eTRE with Brief Intense Stair Climbing (BISC) directly. We believe that the proposed study will address the concerns mentioned previously and further knowledge associated with eTRE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eTRE | Experimental | Behavioral: eTREparticipants allocated to this group are required to consume food during 0800h and 1600h. |
| eTRE with BISC | Active comparator | Behavioral: eTRE with BISCparticipants allocated to this group are required to consume food during 0800h and 1600h as well as complete 3 sessions of BISC per week. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- sedentary- lightly physically active (<7,500 steps daily)
- BMI > 25 • 18-39 years old
Key exclusion criteria (8 listed)
- Have diabetes (self-reported)
- Are pregnant or become pregnant during the study (self-reported)
- Take medication for weight loss (self-reported)
- Physical activity level > 7500 steps/day
- Unstable weight for 3 months prior to commencement of study (>4kg weight loss/gain) • Employed in a shift work position
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 |
|---|---|---|
| eTREeating between 0800h and 1600h daily | Behavioural | eTRE |
| eTRE with BISCeating between 0800h and 1600h daily and completing 3 sessions of BISC per week of study duration | Behavioural | eTRE with BISC |
Primary outcome
Body Composition
Time frame: less than 5 mins
fat mass vs. fat-free mass via BodPod
3 secondary outcomes
upper body strength test
Time frame: < 15 mins
lower body strength test
Time frame: < 15 mins
health related quality of life questionnaire
Time frame: < 10 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eTRE and eTRE with BISC in people with eTRE (Early Time Restricted Eating) and eTRE With BISC (Brief Intense Stair Climbing), run by Western University, Canada 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 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lemon, PhD (519-661-2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: less than 5 mins). 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 30 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.