- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04590729
Interrupting Sitting Time During Postprandial State
November 21, 2020 updated by: Tongyu Ma, Franklin Pierce University
Redistributing Intermittent Physical Activity Breaks to Target Postprandial Glucose Excursion.
The literature has shown that interrupting sitting time with frequent physical activities (e.g., cycling on a stationary bike for 3 minutes every 30 minutes of sitting) is effective for decreasing blood sugar levels.
However, the optimal frequency and distribution of sitting interruption remains less clear.
The purpose of this study is to compare the effects of two different protocols of sitting interruption (i.e., 3 minutes of cycling every 30 minutes versus 3 minutes of cycling every 15 minutes) on blood sugar levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will involve two different physical activity conditions and a control condition.
Each participant will undergo the three conditions in a random order.
The first protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise.
The second protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 15 minutes for 3 hours to match the total exercise duration in the first protocol.
Participants will remain seated for 3 hours to match to the total time spent in the lab.
For the control condition, participants will remain seated.
For each condition, participants will be provided with two meals, one before the protocol and another one in the middle of the protocol.
The meals will be purchased from the cafeteria on campus based on the participant's own choice as long as carbohydrates account for 55-65% of total calories.
Participants will eat identical meals across the three conditions.
Study Type
Interventional
Enrollment (Actual)
11
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
-
-
New Hampshire
-
Rindge, New Hampshire, United States, 03461
- Franklin Pierce University
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Apparently healthy persons
- Sedentary lifestyle
Exclusion Criteria:
- Cardiovascular diseases
- Pulmonary diseases
- Metabolic diseases
- Other contraindications to exercise
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3-min Exercise Per 30 Min
This protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise.
|
This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise.
|
Experimental: 3-min Exercise Per 15 Min
This protocol involves 3 minutes of cycling on a stationary bike at moderate intensity every 15 minutes for 3 hours to match the total exercise duration in the first protocol.
|
This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 15 minutes for 3 hours, totaling 36 minutes of cycling exercise.
|
No Intervention: Sitting
Sitting control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial glucose levels
Time Frame: three and a half hour after the carbohydrates intake
|
The investigators will measure capillary blood sugar levels every 30 minutes using the finger-stick method.
|
three and a half hour after the carbohydrates intake
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tongyu Ma, Ph.D., Franklin Pierce University
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 20, 2020
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
November 20, 2020
Study Registration Dates
First Submitted
October 11, 2020
First Submitted That Met QC Criteria
October 11, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 21, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- TM9282020
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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