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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Singapore
      • Singapore, Singapore, 117599
        • Clinical Nutrition Research Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Centre, Singapore

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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