Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03896828
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daniel Moore, University of Toronto

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE October 19, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Postprandial insulin area under the curve (AUC) to breakfast and lunch [ Time Frame: 3-hr postprandial ]
The plasma insulin concentration measured by enzyme-linked immunosorbent assay area under the curve will be measured using the trapezoidal rule.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Postprandial glucose area under the curve (AUC) to breakfast and lunch [ Time Frame: 3-hr postprandial ]
    The plasma glucose concentration measured by hexokinase method area under the curve will be measured using the trapezoidal rule.
  • Skeletal muscle dietary protein incorporation [ Time Frame: 7.5hr postprandial ]
    [2H5]Phe and [13C6]Phe incorporation into new myofibrillar (contractile) proteins will be determined by LC/MS/MS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Practical Approaches for Interrupting Prolonged Sitting to Improve Postprandial Glucose and Protein Metabolism
Official Title  ICMJE Practical Approaches for Interrupting Prolonged Sitting to Improve Postprandial Glucose and Protein Metabolism
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Healthy Adults
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Sedentary
    Sedentary (SED): Participants will remain seated in the lab all-day (7.5 hr).
    Intervention: Dietary Supplement: Mixed-macronutrient meal
  • 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).
    Intervention: Dietary Supplement: Mixed-macronutrient meal
  • 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).
    Intervention: Dietary Supplement: Mixed-macronutrient meal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jenna Gillen, Ph.D. 14169783244 jenna.gillen@utoronto.ca
Contact: Daniel Moore, Ph.D. 416-946-4088 dr.moore@utoronto.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03896828
Other Study ID Numbers  ICMJE SSW
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daniel Moore, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel Moore, Ph.D University of Toronto
PRS Account University of Toronto
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP