Physical ActivityNCT03374436
Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function
A study testing High-Carbohydrate Sedentary, High-Carbohydrate Active and Low-carbohydrate Sedentary in people with Physical Activity and Diet Modification, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Diet Modification
- What is being tested?
- High-Carbohydrate Sedentary, High-Carbohydrate Active and Low-carbohydrate Sedentary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2017to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 3G1
About this study
Official title: Salivary Insulin Profiles Throughout the Day in Healthy Humans
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.
- Conditions
- Physical Activity, Diet Modification
- Being tested
- High-Carbohydrate Sedentary, High-Carbohydrate Active, Low-carbohydrate Sedentary
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Carbohydrate SedentaryBehavioural
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 ActiveBehavioural
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.
Low-carbohydrate SedentaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Carbohydrate Sedentary | Experimental | Participants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals) Receives: 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). Receives: 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) Receives: Behavioral: Low-carbohydrate Sedentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured across 9 hours of each intervention day
Secondary outcomes (7)
Saliva insulin area under the curve
The saliva insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
Measured: Measured across 9 hours of each intervention day
Plasma glucose area under the curve
The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
Measured: Measured across 9 hours of each intervention day
Plasma triglyceride area under the curve
The plasma triglyceride concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
Measured: Measured across 9 hours of each intervention day
Plasma non-esterified fatty acids area under the curve
The plasma non-esterified fatty acid concentration measured by biochemical assay area under the curve will be measured using the trapezoidal rule.
Measured: Measured across 9 hours of each intervention day
Femoral artery flow-mediated dilation
Flow-mediated dilation of femoral artery measured by vascular ultrasound
Measured: Measured in the morning (time 0 hours) and afternoon (time 8.5 hours) each intervention day
Cerebrovascular function
Cerebrovascular function measured by transcranial doppler ultrasound
Measured: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
Cognitive function
Cognitive function measured by Computerized Neurocognitive Assessment Software (CNS) Vital Signs test battery
Measured: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Oct 2017
- Primary completion30 Jun 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants complete three conditions in a repeated crossover design.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, CoreHealth Technologies Inc.
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374436
- Sponsor's protocol ID
- H17-01747
- Status last verified
- Sep 2019
- First submitted
- 11 Dec 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share individual patient data (de-identified) with researchers upon request.
Publications
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.
PubMed 37262929Caldwell 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.
PubMed 33242251
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Insulin Profiles Throughout the Day in Healthy Humans
- ClinicalTrials.gov ID
- NCT03374436
- Acronym / sponsor ID
- H17-01747
- Conditions
- Physical Activity, Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mitacs, CoreHealth Technologies Inc.
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants complete three conditions in a repeated crossover design.
| Arm | Type | Receives |
|---|---|---|
| High-Carbohydrate Sedentary | Experimental | Behavioral: High-Carbohydrate SedentaryParticipants will remain seated for 9 hours (except for using the restroom) while consuming a high-carbohydrate diet (3 meals) |
| High-Carbohydrate Active | Experimental | Behavioral: High-Carbohydrate ActiveParticipants 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). |
| Low-Carbohydrate Sedentary | Active comparator | Behavioral: Low-carbohydrate SedentaryParticipants will remain seated for 9 hours (except for using the restroom) while consuming a low-carbohydrate diet (3 meals) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Carbohydrate SedentaryThree 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. | Behavioural | High-Carbohydrate Sedentary |
| High-Carbohydrate ActiveThree 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. | Behavioural | High-Carbohydrate Active |
| Low-carbohydrate SedentaryThree 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. | Behavioural | Low-Carbohydrate Sedentary |
Primary outcome
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.
7 secondary outcomes
Saliva insulin area under the curve
Time frame: Measured across 9 hours of each intervention day
Plasma glucose area under the curve
Time frame: Measured across 9 hours of each intervention day
Plasma triglyceride area under the curve
Time frame: 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
Femoral artery flow-mediated dilation
Time frame: 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
Cognitive function
Time frame: Measured in the morning (time 0.5 hours) and afternoon (time 6 hours) each intervention day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 37262929Rafiei 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.
- Derived from this study: PubMed 33242251Caldwell 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.
- Individual participant dataSharing planned: Undecided. We will share individual patient data (de-identified) with researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Carbohydrate Sedentary, High-Carbohydrate Active and Low-carbohydrate Sedentary in people with Physical Activity and Diet Modification, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma insulin area under the curve (time frame: Measured across 9 hours of each intervention day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03374436, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.