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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02594618
Other study ID # 2014/00631
Secondary ID
Status Completed
Phase N/A
First received October 27, 2015
Last updated August 1, 2016
Start date August 2014
Est. completion date April 2016

Study information

Verified date August 2016
Source Clinical Nutrition Research Centre, Singapore
Contact n/a
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 21 Years to 39 Years
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Singapore Clinical Nutrition Research Centre Singapore

Sponsors (1)

Lead Sponsor Collaborator
Clinical Nutrition Research Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 0 to 20 minutes No