- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378115
Energy Cost of Posture Maintenance, Ethnic Differences and the Influence of Metabolic State
April 1, 2018 updated by: JeyaKumar Henry, Clinical Nutrition Research Centre, Singapore
The purpose of this study is to determine the magnitude of changes in energy expenditure and respiratory quotient (RQ) during sitting and standing in Asian men.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will recruit 30-40 young healthy Asian men of Chinese, Malay or Indian descent.
Volunteers will visit Clinical Nutrition Research Centre (CNRC) on 1 or 2 occasions: once for consenting and screening procedures (visit 1) and once to follow a 3 hour test session (visit 2).
Consenting, screening and the test protocol can take place on the same day or can be scheduled on separate days.
In this study the investigators will study the changes in energy expenditure and substrate oxidation when changing posture between sitting and standing.
Visit 1 (screening): For screening, potential subjects will come in the morning after an overnight fast.
After obtaining informed consent, a series of screening tests will be conducted, including questionnaires (general health, physical activity and eating behaviour), anthropometry (height, weight), blood pressure, resting heart rate, body composition and body proportions (waist circumference, hip circumference, sitting height, leg length, relative leg length, mid-arm circumference, mid-thigh circumference, calf circumference).
The physical activity questionnaire will quantify physical activity level.
The eating behaviour questionnaire will determine intentional restriction of food intake.
Body composition will be measured using an electrical impedance analyser and the BodPod.
Body proportions will be measured using a non-stretch measuring tape.
Blood pressure and resting heart rate will be measured using an automatic blood pressure monitor.
All these methods are non-invasive and do not cause any pain.
Visit 2: This test session will last for approximately 3 hours in the morning, during which the following will take place: During each test session, the subject arrive at the centre between 8:00 and 9:00 in the morning after an overnight fast and has been instructed to avoid any physical activity/exercise and alcohol on the day prior to the test.
The session will start after the subject enter the whole body calorimeter.
The first 45 minutes after entering, resting metabolic rate will be measured.
Therefore, the subject will lie down comfortably on a bed in a supine position.
Over the following 60 minutes the subject will alternate a sitting and standing position every 15 minutes based on the researchers instructions.
The subject will then receive a drink and snack to consume and there will be a 15 minute break in which the subject can take a toilet break if necessary.
The break will be followed by a second sequence of 60 minutes in which the subject alternates a sitting and standing position every 15 minutes.
After this subject will leave the whole body calorimeter and is free to go home.
Study Type
Observational
Enrollment (Actual)
30
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
-
-
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Singapore, Singapore, 117599
- Clinical Nutrition Research Cenre
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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
21 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Healthy Chinese/Malay/Indian
Description
Inclusion Criteria:
- Healthy Male
- Age between 21-40 years old
- Chinese, Malay or Indian Ethnicity
- Body mass index between 18.5 - 28 kg/m2
- Normal blood pressure (<140/90 mmHg)
- Do not have metabolic diseases (such as diabetes, hypertension etc.)
- Do not have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Do not take prescription medication that may affect metabolism
- Do not intentionally restrict food intake
- Do not have intolerances or allergies to test foods
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of energy expenditure and respiratory quotient (RQ) in sitting and standing positions
Time Frame: Up to 3 hours
|
Measured using Whole Body Calorimeter
|
Up to 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
May 25, 2017
Primary Completion (ACTUAL)
March 26, 2018
Study Completion (ACTUAL)
March 26, 2018
Study Registration Dates
First Submitted
December 15, 2017
First Submitted That Met QC Criteria
December 15, 2017
First Posted (ACTUAL)
December 19, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 3, 2018
Last Update Submitted That Met QC Criteria
April 1, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2017/00285
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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