- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02981927
Bed Rest, Inactivity and Early Responses (BIER)
May 23, 2018 updated by: University of Exeter
To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e.
bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
Devon
-
Exeter, Devon, United Kingdom, EX1 2LU
- Sport & Health Sciences
-
-
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 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy and aged 18-40 y
- BMI between 18 and 30
Exclusion Criteria:
- On medication
- Family history of metabolic disease
- Diagnosed with any metabolic or cardiovascular conditions
- BMI < 18 or > 30
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
24 h habitual physical activity fed in energy balance
|
|
|
Experimental: Bed rest matched diet
24 hour period of whole body bed-rest with a matched diet
|
|
|
Experimental: Bed rest balanced diet
24 hour period of whole body bed-rest fed in energy balance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glucose tolerance
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2015
Primary Completion (Actual)
December 2, 2016
Study Completion (Actual)
December 2, 2016
Study Registration Dates
First Submitted
November 30, 2016
First Submitted That Met QC Criteria
November 30, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Actual)
May 25, 2018
Last Update Submitted That Met QC Criteria
May 23, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 157758/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.