- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03896828
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
14
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Sedentary
Sedentary (SED): Participants will remain seated in the lab all-day (7.5 hr).
|
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).
|
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).
|
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
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
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
Investigators
- 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)
October 19, 2018
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
March 28, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID 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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