NCT06240442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 14, 2024

Last Update Submit

January 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average blood glucose concentration

    Average blood glucose concentration during postprandial period

    2 hours

Secondary Outcomes (5)

  • Blood glucose concentration

    2 hours

  • Blood glucose area under the curve

    2 hours

  • Peak blood glucose concentration

    2 hours

  • Post-exercise fat oxidation

    pre-exercise, immediately post-exercise, up to 3 hours post-exercise

  • Appetite Perceptions

    pre-exercise, immediately post-exercise, and 1, 2 and 3 hours post-exercise

Study Arms (2)

Fasted Exercise

EXPERIMENTAL

Exercise followed by breakfast

Other: Fasted exercise

Fed Exercise

EXPERIMENTAL

Breakfast followed by exercise

Other: Fed exercise

Interventions

Bodyweight interval exercise performed 5 minutes before the start of a mixed-macronutrient breakfast meal

Fasted Exercise

Bodyweight interval exercise performed 10 minutes after the start of consuming a mixed-macronutrient breakfast meal

Fed Exercise

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jenna Gillen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 14, 2024

First Posted

February 5, 2024

Study Start

May 14, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations