Practical Approaches for Interrupting Prolonged Sitting to Improve Postprandial Glucose and Protein Metabolism

January 18, 2022 updated by: Daniel Moore, University of Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2C9
        • Goldring Center for High Performance Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sedentary
Sedentary (SED): Participants will remain seated in the lab all-day (7.5 hr).
Dietary supplement: Mixed-macronutrient meal
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.
Experimental: Walking Breaks
Walking breaks (WALK): Participants will perform 2-minute walking breaks at 3.1 mph on a treadmill every 30 minutes (7.5 hr).
Dietary supplement: Mixed-macronutrient meal
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.
Experimental: Resistance-exercise breaks
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).
Dietary supplement: Mixed-macronutrient meal
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 hours postprandial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial glucose area under the curve (AUC) to breakfast and lunch
Time Frame: 3 hours postprandial
The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
3 hours postprandial
Skeletal muscle dietary protein incorporation
Time Frame: 7.5 hours postprandial
[2H5]Phe and [13C6]Phe incorporation into new myofibrillar (contractile) proteins will be determined by LC/MS/MS
7.5 hours postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Moore, Ph.D, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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