Clinical trial NCT06240442: Bodyweight Interval Exercise in the Fed Versus Fasted State
Official title: Bodyweight Interval Exercise in the Fed Versus Fasted State on Postprandial Glycemia, Appetite Perceptions and Fat Oxidation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average blood glucose concentration
timeFrame: 2 hours
Secondary outcomes:
measure: Blood glucose concentration
timeFrame: 2 hours
measure: Blood glucose area under the curve
timeFrame: 2 hours
measure: Peak blood glucose concentration
timeFrame: 2 hours
measure: Post-exercise fat oxidation
timeFrame: pre-exercise, immediately post-exercise, up to 3 hours post-exercise
measure: Appetite Perceptions
timeFrame: pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jenna Gillen, PhD
role: PRINCIPAL_INVESTIGATOR
References: