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Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function

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ClinicalTrials.gov Identifier: NCT03374436
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
Mitacs
CoreHealth Technologies Inc.
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Brief Summary:
Prolonged sitting has been shown to impair metabolism and vascular function. The overall purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with brief (~20 second) stair climbing exercise "snacks" can improve markers of metabolic control and vascular health in healthy young male participants. An additional purpose is to determine if saliva insulin can be used as a valid indicator of blood insulin when measured throughout the day in sedentary and active conditions and when diets with different amounts of carbohydrates are consumed.

Condition or disease Intervention/treatment Phase
Physical Activity Diet Modification Behavioral: High-Carbohydrate Sedentary Behavioral: High-Carbohydrate Active Behavioral: Low-carbohydrate Sedentary Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants complete three conditions in a repeated crossover design.
Masking: None (Open Label)
Masking Description: It is not possible to mask the exercise or diet interventions.
Primary Purpose: Other
Official Title: Salivary Insulin Profiles Throughout the Day in Healthy Humans
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : October 30, 2018

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)
Behavioral: High-Carbohydrate Sedentary
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).
Behavioral: High-Carbohydrate Active
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)
Behavioral: Low-carbohydrate Sedentary
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Non-smoking

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374436


Locations
Canada, British Columbia
University of British Columbia Okanagan Recruiting
Kelowna, British Columbia, Canada, V1V 3G1
Contact: Hossein Rafiei    2508079122    hossien.rafiei@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Mitacs
CoreHealth Technologies Inc.

Responsible Party: Jonathan Little, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03374436     History of Changes
Other Study ID Numbers: H17-01747
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We will share individual patient data (de-identified) with researchers upon request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No