NCT03374436

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 and in males or females with overweight/obesity who are at risk of insulin resistance. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration 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

October 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

December 11, 2017

Last Update Submit

September 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma insulin area under the curve

    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 Outcomes (7)

  • Saliva insulin area under the curve

    Measured across 9 hours of each intervention day

  • Plasma glucose area under the curve

    Measured across 9 hours of each intervention day

  • Plasma triglyceride area under the curve

    Measured across 9 hours of each intervention day

  • Plasma non-esterified fatty acids area under the curve

    Measured across 9 hours of each intervention day

  • Femoral artery flow-mediated dilation

    Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day

  • +2 more secondary outcomes

Study Arms (3)

High-Carbohydrate Sedentary

EXPERIMENTAL

Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals)

Behavioral: High-Carbohydrate Sedentary

High-Carbohydrate Active

EXPERIMENTAL

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

Low-Carbohydrate Sedentary

ACTIVE COMPARATOR

Participants will remain seated for 9 hours (except for using the restroom) while consuming a low-carbohydrate diet (3 meals)

Behavioral: Low-carbohydrate Sedentary

Interventions

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.

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 except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint "snack") for a total of 8 active breaks.

High-Carbohydrate Active

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.

Low-Carbohydrate Sedentary

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking

You may not qualify if:

  • 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.
  • Elevated waist circumference (\>102 cm for male and \>88 cm for female)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

Location

Related Publications (2)

  • Rafiei H, Omidian K, Chang CR, Little JP. Saliva insulin tracks plasma insulin across the day following high-carbohydrate and low-carbohydrate meals. Appl Physiol Nutr Metab. 2023 Sep 1;48(9):700-709. doi: 10.1139/apnm-2023-0066. Epub 2023 Jun 1.

  • Caldwell HG, Coombs GB, Rafiei H, Ainslie PN, Little JP. Hourly staircase sprinting exercise "snacks" improve femoral artery shear patterns but not flow-mediated dilation or cerebrovascular regulation: a pilot study. Appl Physiol Nutr Metab. 2021 May;46(5):521-529. doi: 10.1139/apnm-2020-0562. Epub 2020 Nov 26.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
It is not possible to mask the exercise or diet interventions.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants complete three conditions in a repeated crossover design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 15, 2017

Study Start

October 1, 2017

Primary Completion

June 30, 2019

Study Completion

August 30, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations