- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240442
Bodyweight Interval Exercise in the Fed Versus Fasted State (BWE)
Bodyweight Interval Exercise in the Fed Versus Fasted State on Postprandial Glycemia, Appetite Perceptions and Fat Oxidation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2C9
- Goldring Centre for High Performance Sport
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fasted Exercise
Exercise followed by breakfast
|
Bodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal
|
Experimental: Fed Exercise
Breakfast followed by exercise
|
Bodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average blood glucose concentration
Time Frame: 2 hours
|
Average blood glucose concentration during postprandial period
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose concentration
Time Frame: 2 hours
|
Blood glucose concentration across postprandial period
|
2 hours
|
Blood glucose area under the curve
Time Frame: 2 hours
|
blood glucose area under the curve during postprandial period
|
2 hours
|
Peak blood glucose concentration
Time Frame: 2 hours
|
peak glucose across postprandial period
|
2 hours
|
Post-exercise fat oxidation
Time Frame: pre-exercise, immediately post-exercise, up to 3 hours post-exercise
|
post-exercise fat oxidation measured as percent carbon dioxide
|
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
|
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.
|
pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jenna Gillen, PhD, University of Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 40799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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