- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02594618
Energy Metabolism and Cost of Physical Activities Using Whole Body Calorimeter
August 1, 2016 updated by: Melvin Leow, Clinical Nutrition Research Centre, Singapore
The aim of this study is to assess energy regulation of overfeeding and performing common household activities in young Chinese males using whole-body room calorimetry up to 10 hours.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will require participants to stay in the room calorimeters for up to 5 hours on each of the 3 test sessions.
The participants are to avoid intense physical activity/alcohol and to record their food intake for the day prior to test day.
They will record their food intake for the day prior to test session 1 in a food diary (to be provided to them on the day of screening).
Records will be used to ascertain participants' food intake patterns.
They will report to Clinical Nutrition Research Centre (CNRC) in the morning after an overnight (10-12 hours) fast.
Basic anthropometric measurements will be taken at the start of the test session before participants enter the room calorimeter.
The room calorimeter is a 13.5 m3 chamber furnished with features to give an impression of a normal room with windows on three sides of the chamber for outside view and visual contact with researchers.
It has a full sized foldaway bed, a fold-down writing table, an office chair, a built-in sink and mirror, a portable freeze-dry toilet bowl, a television, a telephone, computer network connection, an intercom system.
During their stay in the room calorimeter, energy expenditure will be measured based on recorded oxygen consumption and carbon dioxide production over 10 hours.
Participants are allowed to rest, sit and move freely, except sleep or exercise during their stay.
On each of the 3 test sessions, the subjects will perform up to 4 common household activities (e.g.
mopping floor, washing dishes, etc) 1 hour after consuming the light breakfast.
On test session 1, the light breakfast consist of biscuits and a juice drink and will be provided to the participants after they have undergone assessment of metabolism at rest for approximately 45 minutes in the room calorimeter.
On test session 2 and 3, the same light breakfast will be provided after approximately 15 minutes after they have entered the room calorimeter.
During their 4-5 hours stay in the room calorimeter, they will simulate a particular household activity for up to 20 minutes and rest for 30 minutes before continuing with another household activity and so on for up to 4 different household activities at each of the test sessions.
Study Type
Observational
Enrollment (Actual)
20
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 Centre
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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 39 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Male healthy subjects who are of Chinese ethnicity
Description
Inclusion Criteria:
- Male
- Ethnic Chinese
- Age between 21 to 39 years
- Body mass 60 to 70 kg
- Body height 165 to 175 cm
- Normal resting blood pressure ~120/80 mmHg
- Normal fasting blood glucose level <5.5 mmol/L
- Do not train for or partake in competitive sports
- Do not have any major diseases
- Not on any prescribed medication
- Willing and able to consume all test meals
- Not allergic to any food ingredient found in all test meals
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?
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measuring energy cost of domestic physical activities using whole body calorimeter
Time Frame: 0 to 20 minutes
|
Energy expenditure is measured for 20 minutes continuously throughout the domestic activity performed by the subject.
|
0 to 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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
August 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
October 27, 2015
First Submitted That Met QC Criteria
October 31, 2015
First Posted (Estimate)
November 3, 2015
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2014/00631
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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