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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06240442
Other study ID # 40799
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2021
Est. completion date August 30, 2021

Study information

Verified date January 2024
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. This is a remote/online study and does not involve any visits to the laboratory.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date August 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Fasted exercise
Bodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal
Fed exercise
Bodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal

Locations

Country Name City State
Canada Goldring Centre for High Performance Sport Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average blood glucose concentration Average blood glucose concentration during postprandial period 2 hours
Secondary Blood glucose concentration Blood glucose concentration across postprandial period 2 hours
Secondary Blood glucose area under the curve blood glucose area under the curve during postprandial period 2 hours
Secondary Peak blood glucose concentration peak glucose across postprandial period 2 hours
Secondary Post-exercise fat oxidation post-exercise fat oxidation measured as percent carbon dioxide pre-exercise, immediately post-exercise, up to 3 hours post-exercise
Secondary 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. pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise
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