- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03374436
Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function
Salivary Insulin Profiles Throughout the Day in Healthy Humans
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 3G1
- University of British Columbia Okanagan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Lean Group Inclusion Criteria:
Non-smoking
Lean Group Exclusion Criteria:
Diagnosed with diabetes or prediabetes (fasting blood sugar more than 6.0 mmol/l) or any other chronic condition that may impact glucose or insulin levels.
BMI is over 25 kg/m2 Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.
Overweight/Obese Group Inclusion Criteria:
Elevated waist circumference (>102 cm for male and >88 cm for female)
Overweight/Obese Group Exclusion Criteria:
Diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) Take medications which may affect glucose and insulin levels Allergic to eggs. Smoker Competitive or serious endurance athlete.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-Carbohydrate Sedentary
Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals)
|
Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.
|
|
Experimental: High-Carbohydrate Active
Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals) but will complete 8 stair climbing sprint "snacks" once per hour involving ascending 3 flights of stairs at a vigorous pace (~20 seconds each).
|
Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint "snack") for a total of 8 active breaks.
|
|
Active Comparator: Low-Carbohydrate Sedentary
Participants will remain seated for 9 hours (except for using the restroom) while consuming a low-carbohydrate diet (3 meals)
|
Three low-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.
This condition will provide a condition where the blood glucose and insulin responses are relatively low and stable throughout the day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma insulin area under the curve
Time Frame: Measured across 9 hours of each intervention day
|
The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
|
Measured across 9 hours of each intervention day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Saliva insulin area under the curve
Time Frame: Measured across 9 hours of each intervention day
|
The saliva insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
|
Measured across 9 hours of each intervention day
|
|
Plasma glucose area under the curve
Time Frame: Measured across 9 hours of each intervention day
|
The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
|
Measured across 9 hours of each intervention day
|
|
Plasma triglyceride area under the curve
Time Frame: Measured across 9 hours of each intervention day
|
The plasma triglyceride concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
|
Measured across 9 hours of each intervention day
|
|
Plasma non-esterified fatty acids area under the curve
Time Frame: Measured across 9 hours of each intervention day
|
The plasma non-esterified fatty acid concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
|
Measured across 9 hours of each intervention day
|
|
Femoral artery flow-mediated dilation
Time Frame: Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day
|
Flow-mediated dilation of femoral artery measured by vascular ultrasound
|
Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day
|
|
Cerebrovascular function
Time Frame: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
|
Cerebrovascular function measured by transcranial doppler ultrasound
|
Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
|
|
Cognitive function
Time Frame: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
|
Cognitive function measured by Computerized Neurocognitive Assessment Software (CNS) Vital Signs test battery
|
Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H17-01747
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
Clinical Trials on High-Carbohydrate Sedentary
-
Uppsala UniversityCompleted
-
University of MichiganNorthern Michigan UniversityCompletedGlucose Intolerance
-
University of TorontoCompleted
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
Mayo ClinicCompleted
-
Haukeland University HospitalUniversity of BergenCompleted
-
Vårdcentralen LyckornaCompleted
-
University of ArkansasCompletedDiabetes Mellitus | HypertriglyceridemiaUnited States
-
Baylor UniversityCompleted
-
National University of SingaporeActive, not recruitingPersonalized NutritionSingapore