ExerciseBWENCT06240442
Bodyweight Interval Exercise in the Fed Versus Fasted State
A study testing Fasted exercise and Fed exercise in people with Exercise, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the effects of a single session of at-home bodyweight interval exercise, performed in the fasted or fed state, on postprandial glycemic management, post-exercise fat oxidation, and overall perceptions of appetite in recreationally active females. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Fasted exercise and Fed exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 14 May 2021to 30 Aug 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females 18-35 years
- Recreationally active (complete <150 min of exercise 1-3 days per week) and not training for any specific sport
- Experiencing monthly menstrual periods (eumenorrheic)
- Are not currently on oral contraceptives, or are taking triphasic oral contraceptives
- Body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2
- Regular consumption of a breakfast meal (solid and liquid meals apply) most (≥ 4) days of the week
- Have a device compatible for use with study applications (e.g., smart phone)
Who cannot join
- Inability to safely perform physical activity as determined by the Get Active Questionnaire
- Not willing to consume the standardized test drink before and after exercise
- Sensitive to meal timing around exercise (e.g., gastrointestinal issues if exercise performed 10 min after the start of meal consumption or if a meal is consumed 5 min after exercise)
- Inability to adhere to pre-trial protocol guidelines (e.g., caffeine or alcohol restrictions)
- Physical limitations for bodyweight exercise
- Are on monophasic or biphasic oral contraceptives
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- Regular tobacco or cannabis use (e.g., recreational and/or medical cannabis, cigarettes, e-cigarettes, vape pens, JUUL)
- Regular use of drugs that may alter metabolism (e.g., corticosteroids, nSAIDs)
- Diagnosed medical condition under the care of care of a physician (e.g., type 2 diabetes, cardiovascular disease) Currently enrolled in a course with Dr. Gillen
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
Official title: Bodyweight Interval Exercise in the Fed Versus Fasted State on Postprandial Glycemia, Appetite Perceptions and Fat Oxidation
The purpose of this study is to investigate the effects of a single session of at-home bodyweight interval exercise, performed in the fasted or fed state, on postprandial glycemic management, post-exercise fat oxidation, and overall perceptions of appetite in recreationally active females. This is a remote/online study and does not involve any visits to the laboratory.
Read the detailed description
Following the acquisition of informed consent via videoconferencing, eligibility to participate in the study will be determined using questionnaires. If inclusion criteria is met, participants will undergo virtual exercise familiarization by following a pre-recorded instructional video.
Eligible participants will be assigned, in a random order, to two metabolic trials at least 3 days apart in the follicular phase of the same menstrual cycle. These visits will be online with an investigator on videoconferencing. The two trials involve: 1) Exercise followed by breakfast; and 2) Breakfast followed by exercise.
Various outcomes will be measured throughout the metabolic trials including: blood sugar, fat oxidation and appetite. All research tools needed to acquire these methods will be delivered to participants' place of residence.
- Conditions
- Exercise
- Being tested
- Fasted exercise, Fed exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted exerciseOther
Bodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal
Fed exerciseOther
Bodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal
| Study group | Role | What they receive |
|---|---|---|
| Fasted Exercise | Experimental | Exercise followed by breakfast Receives: Other: Fasted exercise |
| Fed Exercise | Experimental | Breakfast followed by exercise Receives: Other: Fed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average blood glucose concentration
Average blood glucose concentration during postprandial period
Measured: 2 hours
Secondary outcomes (5)
Blood glucose concentration
Blood glucose concentration across postprandial period
Measured: 2 hours
Blood glucose area under the curve
blood glucose area under the curve during postprandial period
Measured: 2 hours
Peak blood glucose concentration
peak glucose across postprandial period
Measured: 2 hours
Post-exercise fat oxidation
post-exercise fat oxidation measured as percent carbon dioxide
Measured: pre-exercise, immediately post-exercise, up to 3 hours post-exercise
Appetite Perceptions
Visual analog scales (0-100) will be used to determine perceptions of hunger, satisfaction, fullness, and prospective food consumption with higher scores denoting increased perceptions.
Measured: pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start14 May 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gillen, University of Toronto
- Investigators
- Jenna Gillen, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240442
- Sponsor's protocol ID
- 40799
- Acronym
- BWE
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 5 Feb 2024
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bodyweight Interval Exercise in the Fed Versus Fasted State on Postprandial Glycemia, Appetite Perceptions and Fat Oxidation
- ClinicalTrials.gov ID
- NCT06240442
- Acronym / sponsor ID
- BWE / 40799
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Feb 2024 (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.
The purpose of this study is to investigate the effects of a single session of at-home bodyweight interval exercise, performed in the fasted or fed state, on postprandial glycemic management, post-exercise fat oxidation, and overall perceptions of appetite in recreationally active females. This is a remote/online study and does not involve any visits to the laboratory.
Detailed description
Following the acquisition of informed consent via videoconferencing, eligibility to participate in the study will be determined using questionnaires. If inclusion criteria is met, participants will undergo virtual exercise familiarization by following a pre-recorded instructional video.
Eligible participants will be assigned, in a random order, to two metabolic trials at least 3 days apart in the follicular phase of the same menstrual cycle. These visits will be online with an investigator on videoconferencing. The two trials involve: 1) Exercise followed by breakfast; and 2) Breakfast followed by exercise.
Various outcomes will be measured throughout the metabolic trials including: blood sugar, fat oxidation and appetite. All research tools needed to acquire these methods will be delivered to participants' place of residence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted Exercise | Experimental | Other: Fasted exerciseExercise followed by breakfast |
| Fed Exercise | Experimental | Other: Fed exerciseBreakfast followed by exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females 18-35 years
- Recreationally active (complete <150 min of exercise 1-3 days per week) and not training for any specific sport
- Experiencing monthly menstrual periods (eumenorrheic)
- Are not currently on oral contraceptives, or are taking triphasic oral contraceptives
- Body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2
Key exclusion criteria (9 listed)
- Inability to safely perform physical activity as determined by the Get Active Questionnaire
- Not willing to consume the standardized test drink before and after exercise
- Sensitive to meal timing around exercise (e.g., gastrointestinal issues if exercise performed 10 min after the start of meal consumption or if a meal is consumed 5 min after exercise)
- Inability to adhere to pre-trial protocol guidelines (e.g., caffeine or alcohol restrictions)
- Physical limitations for bodyweight exercise
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 |
|---|---|---|
| Fasted exerciseBodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal | Other | Fasted Exercise |
| Fed exerciseBodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal | Other | Fed Exercise |
Primary outcome
Average blood glucose concentration
Time frame: 2 hours
Average blood glucose concentration during postprandial period
5 secondary outcomes
Blood glucose concentration
Time frame: 2 hours
Blood glucose area under the curve
Time frame: 2 hours
Peak blood glucose concentration
Time frame: 2 hours
Post-exercise fat oxidation
Time frame: pre-exercise, immediately post-exercise, up to 3 hours post-exercise
Appetite Perceptions
Time frame: pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise
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 5 Feb 2024.
- 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.
Jenna Gillen, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasted exercise and Fed exercise in people with Exercise, run by University of Toronto 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 7 inclusion and 9 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 5 Feb 2024. 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?
Average blood glucose concentration (time frame: 2 hours). 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 5 Feb 2024.