Healthy AdultsNCT03896828
Practical Approaches for Interrupting Prolonged Sitting to Improve Postprandial Glucose and Protein Metabolism
A study testing Mixed-macronutrient meal in people with Healthy Adults, run by University of Toronto at 1 site in Canada.
Trial summary
The present study will determine the impact of interrupting prolonged sitting with short, 2-minute walks or body-weight squats on: i) postprandial glycemia and insulinemia, and; ii) postprandial utilization of dietary amino acids. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Mixed-macronutrient meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2018to 1 Dec 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between 18-35 yr
- Recreationally active (≤ 150 minutes of moderate-intensity physical activity per week and no more than 3 days/week of exercise)
- VO2peak considered "good" or below based on ACSM age and sex normative values
- Experiencing regular menstrual periods and not taking hormonal oral contraceptives (females only)
Who cannot join
- Inability to perform physical activity as determined by the PAR-Q
- Inability to adhere to protocol guidelines (e.g. alcohol, standardized diet)
- Physical limitations for walking or repeatedly rising from a chair
- Regular tobacco use
- Illicit drug use (e.g. growth hormone, testosterone)
- Hormonal oral contraceptive use (females only)
- Diagnosed medical condition under the care of a physician (e.g. type 2 diabetes)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Goldring Center for High Performance Sport
Toronto, Ontario, M5S 2C9
About this study
The present study will determine the impact of interrupting prolonged sitting with short, 2-minute walks or body-weight squats on: i) postprandial glycemia and insulinemia, and; ii) postprandial utilization of dietary amino acids. We hypothesize that postprandial glycemia and insulinemia will be similarly improved by interrupting prolonged sitting with short walks or body-weight squats, whereas postprandial utilization of dietary amino acids will only be improved by interrupting prolonged sitting with body-weight squats.
Read the detailed description
Sedentary behavior is an independent risk factor for chronic disease and premature mortality. Despite a growing awareness of the health risks associated with prolonged sitting, Americans spend upwards of 10 hours per day in a sedentary state. Many leisure-time activities and careers of modern society involve prolonged sitting, necessitating an urgent need to identify strategies that mitigate the health consequences of these behaviors. Recent evidence suggests that interrupting prolonged periods of sitting with short breaks of walking or cycling improve postprandial glucose and lipid handling throughout the day. Thus, relatively small quantities of movement represent an efficacious strategy for improving indices of metabolic health. However, more cost-effective and practical interventions that do not require extra space (i.e. walking) or equipment (i.e. cycling or a treadmill desk) beyond one's immediate sedentary space (e.g. office, desk) would help reduce real and/or perceived barriers of adopting this efficacious disease risk-reduction behavior. A currently understudied consequence of prolonged sitting may also be a desensitization of skeletal muscle's ability to use ingested protein, which overtime can result in detriments to the quantity and quality of this important tissue. Body-weight resistance exercise (RE) can augment the body's ability to use ingested protein to support the maintenance of skeletal muscle mass, and therefore may represent a novel exercise mode to minimize consequences of prolonged sitting. The proposed research will be the first to investigate the influence of interrupting prolonged sitting with short breaks of body-weight resistance exercise (RE) on postprandial glucose and protein metabolism. Importantly, the efficacy of this approach will be directly compared to short breaks of walking, which has previously been reported to improve postprandial glycemia in healthy adults.
- Conditions
- Healthy Adults
- Being tested
- Mixed-macronutrient meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed-macronutrient mealDietary supplement
Participants will be provided a mixed-macronutrient meal (liquid drink) at hours "0" and "3", mimicking the energy and macronutrient composition of breakfast and lunch in Western society (38). 20% of daily energy intake will be provided as "breakfast" and 30% at lunch. Macronutrient composition will reflect a diet providing 55% energy needs from carbohydrate (CHO) and 1.2g/kg/d protein. The remaining energy requirements, as determined by total energy intake, will be met with dietary fat (estimated to be ~0.2 and 0.3g/kg fat for breakfast and lunch, respectively), similar to previous liquid mixed-meal approaches.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary | Experimental | Sedentary (SED): Participants will remain seated in the lab all-day (7.5 hr). Receives: Dietary Supplement: Mixed-macronutrient meal |
| Walking Breaks | Experimental | Walking breaks (WALK): Participants will perform 2-minute walking breaks at 3.1 mph on a treadmill every 30 minutes (7.5 hr). Receives: Dietary Supplement: Mixed-macronutrient meal |
| Resistance-exercise breaks | Experimental | Resistance exercise breaks (RE): Participants will perform 15 "squats" (1-minute) every 30 minutes. To reduce the risk of injury, standardize squat-depth, and recruit similar muscle groups as walking, the squats performed will be a "chair-stand with calf-raise" (7.5 hr). Receives: Dietary Supplement: Mixed-macronutrient meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial insulin area under the curve (AUC) to breakfast and lunch
The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
Measured: 3 hours postprandial
Secondary outcomes (2)
Postprandial glucose area under the curve (AUC) to breakfast and lunch
The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
Measured: 3 hours postprandial
Skeletal muscle dietary protein incorporation
[2H5]Phe and [13C6]Phe incorporation into new myofibrillar (contractile) proteins will be determined by LC/MS/MS
Measured: 7.5 hours postprandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start19 Oct 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Fourteen men and women will visit the lab on three separate occasions and will remain seated at a desk all-day (Visit 1) or interrupt this sitting every 30-minutes with either 2-minute walking-breaks (Visit 2) or with 15 body-weight squats (repeatedly rising from a chair and onto tip-toes, Visit 3).
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, University of Toronto
- Investigators
- Daniel Moore, Ph.D, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896828
- Sponsor's protocol ID
- SSW
- Status last verified
- Jan 2022
- First submitted
- 28 Mar 2019
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Approaches for Interrupting Prolonged Sitting to Improve Postprandial Glucose and Protein Metabolism
- ClinicalTrials.gov ID
- NCT03896828
- Acronym / sponsor ID
- SSW
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 Apr 2019 (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.
The present study will determine the impact of interrupting prolonged sitting with short, 2-minute walks or body-weight squats on: i) postprandial glycemia and insulinemia, and; ii) postprandial utilization of dietary amino acids. We hypothesize that postprandial glycemia and insulinemia will be similarly improved by interrupting prolonged sitting with short walks or body-weight squats, whereas postprandial utilization of dietary amino acids will only be improved by interrupting prolonged sitting with body-weight squats.
Detailed description
Sedentary behavior is an independent risk factor for chronic disease and premature mortality. Despite a growing awareness of the health risks associated with prolonged sitting, Americans spend upwards of 10 hours per day in a sedentary state. Many leisure-time activities and careers of modern society involve prolonged sitting, necessitating an urgent need to identify strategies that mitigate the health consequences of these behaviors. Recent evidence suggests that interrupting prolonged periods of sitting with short breaks of walking or cycling improve postprandial glucose and lipid handling throughout the day. Thus, relatively small quantities of movement represent an efficacious strategy for improving indices of metabolic health. However, more cost-effective and practical interventions that do not require extra space (i.e. walking) or equipment (i.e. cycling or a treadmill desk) beyond one's immediate sedentary space (e.g. office, desk) would help reduce real and/or perceived barriers of adopting this efficacious disease risk-reduction behavior. A currently understudied consequence of prolonged sitting may also be a desensitization of skeletal muscle's ability to use ingested protein, which overtime can result in detriments to the quantity and quality of this important tissue. Body-weight resistance exercise (RE) can augment the body's ability to use ingested protein to support the maintenance of skeletal muscle mass, and therefore may represent a novel exercise mode to minimize consequences of prolonged sitting. The proposed research will be the first to investigate the influence of interrupting prolonged sitting with short breaks of body-weight resistance exercise (RE) on postprandial glucose and protein metabolism. Importantly, the efficacy of this approach will be directly compared to short breaks of walking, which has previously been reported to improve postprandial glycemia in healthy adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Fourteen men and women will visit the lab on three separate occasions and will remain seated at a desk all-day (Visit 1) or interrupt this sitting every 30-minutes with either 2-minute walking-breaks (Visit 2) or with 15 body-weight squats (repeatedly rising from a chair and onto tip-toes, Visit 3).
| Arm | Type | Receives |
|---|---|---|
| Sedentary | Experimental | Dietary Supplement: Mixed-macronutrient mealSedentary (SED): Participants will remain seated in the lab all-day (7.5 hr). |
| Walking Breaks | Experimental | Dietary Supplement: Mixed-macronutrient mealWalking breaks (WALK): Participants will perform 2-minute walking breaks at 3.1 mph on a treadmill every 30 minutes (7.5 hr). |
| Resistance-exercise breaks | Experimental | Dietary Supplement: Mixed-macronutrient mealResistance exercise breaks (RE): Participants will perform 15 "squats" (1-minute) every 30 minutes. To reduce the risk of injury, standardize squat-depth, and recruit similar muscle groups as walking, the squats performed will be a "chair-stand with calf-raise" (7.5 hr). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women between 18-35 yr
- Recreationally active (≤ 150 minutes of moderate-intensity physical activity per week and no more than 3 days/week of exercise)
- VO2peak considered "good" or below based on ACSM age and sex normative values
- Experiencing regular menstrual periods and not taking hormonal oral contraceptives (females only)
Key exclusion criteria (7 listed)
- Inability to perform physical activity as determined by the PAR-Q
- Inability to adhere to protocol guidelines (e.g. alcohol, standardized diet)
- Physical limitations for walking or repeatedly rising from a chair
- Regular tobacco use
- Illicit drug use (e.g. growth hormone, testosterone)
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 |
|---|---|---|
| Mixed-macronutrient mealParticipants will be provided a mixed-macronutrient meal (liquid drink) at hours "0" and "3", mimicking the energy and macronutrient composition of breakfast and lunch in Western society (38). 20% of daily energy intake will be provided as "breakfast" and 30% at lunch. Macronutrient composition will reflect a diet providing 55% energy needs from carbohydrate (CHO) and 1.2g/kg/d protein. The remaining energy requirements, as determined by total energy intake, will be met with dietary fat (estimated to be ~0.2 and 0.3g/kg fat for breakfast and lunch, respectively), similar to previous liquid mixed-meal approaches. | Dietary supplement | Resistance-exercise breaks, Sedentary, Walking Breaks |
Primary outcome
Postprandial insulin area under the curve (AUC) to breakfast and lunch
Time frame: 3 hours postprandial
The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
2 secondary outcomes
Postprandial glucose area under the curve (AUC) to breakfast and lunch
Time frame: 3 hours postprandial
Skeletal muscle dietary protein incorporation
Time frame: 7.5 hours postprandial
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 19 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Daniel Moore, Ph.D principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed-macronutrient meal in people with Healthy Adults, run by University of Toronto 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?
The sponsor lists 4 inclusion and 7 exclusion criteria. 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 19 Jan 2022. 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?
Postprandial insulin area under the curve (AUC) to breakfast and lunch (time frame: 3 hours postprandial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2022.