Energy RegulationNCT02594618
Energy Metabolism and Cost of Physical Activities Using Whole Body Calorimeter
An observational study of Energy Regulation, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Regulation
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male healthy subjects who are of Chinese ethnicity
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Energy Regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring energy cost of domestic physical activities using whole body calorimeter
Energy expenditure is measured for 20 minutes continuously throughout the domestic activity performed by the subject.
Measured: 0 to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Food and Biotechnology Innovation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Melvin Leow, Singapore Institute of Food and Biotechnology Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594618
- Sponsor's protocol ID
- 2014/00631
- Other IDs
- 2014
- Status last verified
- Aug 2016
- First submitted
- 27 Oct 2015
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Metabolism and Cost of Physical Activities Using Whole Body Calorimeter
- ClinicalTrials.gov ID
- NCT02594618
- Acronym / sponsor ID
- 2014/00631
- Conditions
- Energy Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore Institute of Food and Biotechnology InnovationOther government
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male healthy subjects who are of Chinese ethnicity
Key inclusion criteria (12 listed)
- Male
- Ethnic Chinese
- Age between 21 to 39 years
- Body mass 60 to 70 kg
- Body height 165 to 175 cm
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Energy Regulation, run by Singapore Institute of Food and Biotechnology Innovation at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring energy cost of domestic physical activities using whole body calorimeter (time frame: 0 to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.