Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000561280
Ethics application status
Approved
Date submitted
1/07/2009
Date registered
9/07/2009
Date last updated
9/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of energy requirements at rest
Scientific title
Validation of nutritional assessment methods in healthy older adults: resting energy expenditure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional status of healthy older adults 237132 0
Condition category
Condition code
Diet and Nutrition 237455 237455 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measurement of resting energy expenditure (REE) in healthy community-dwelling older adults.
REE will be measured by indirect calorimetry using a metabolic measurement cart with a ventilated hood system. Measurements will take place between 06.00 and 09.00, following an overnight fast, in a thermo-neutral (23 degrees celsius) and humidity controlled, quiet, semi-darkened environment. Participants will be placed under the ventilated hood in a relaxed and supine position. Measurement of oxygen consumption and carbon dioxide production will occur continuously for a total of 30 minutes, after 10 minutes of acclimatisation.
Intervention code [1] 236850 0
Not applicable
Comparator / control treatment
There is no comparison group, since comparisons will not be made between participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238260 0
REE measured by indirect calorimetry using a metabolic measurement cart with a ventilated hood system
Timepoint [1] 238260 0
At baseline
Secondary outcome [1] 244622 0
Nil
Timepoint [1] 244622 0
Nil

Eligibility
Key inclusion criteria
Healthy community-dwelling older adults
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged less than 70 years;
In residential care;
History of recent bone fracture;
Hypothyroidism;
Hyperthyroidism;
Oedema;
Taking diuretic medications; or
Taking thyroid hormones

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
442
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237238 0
University
Name [1] 237238 0
Flinders University, Faculty of Health Sciences
Country [1] 237238 0
Australia
Primary sponsor type
Individual
Name
Dr Michelle Miller
Address
Nutrition and Dietetics,
Flinders Clinical and Molecular Medicine,
School of Medicine,
Flinders University,
GPO Box 2100,
Adelaide,
SA 5001
Country
Australia
Secondary sponsor category [1] 236726 0
None
Name [1] 236726 0
Address [1] 236726 0
Country [1] 236726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239339 0
Flinders Clinical Research and Ethics Committee
Ethics committee address [1] 239339 0
GPO Box 2100,
Adelaide,
SA 5001
Ethics committee country [1] 239339 0
Australia
Date submitted for ethics approval [1] 239339 0
Approval date [1] 239339 0
12/03/2009
Ethics approval number [1] 239339 0
68/09

Summary
Brief summary
In order to prevent weight loss it is essential that energy intake and energy expenditure are in balance. Resting energy expenditure (REE) accounts for 65-75% of total energy expenditure, and is principally determined by body mass, therefore variations occur with body weight, body composition, age and gender. In order to reliably estimate energy requirements it is necessary to be able to assess REE accurately. Numerous equations have been developed for this purpose, and validated in different populations; however there is a lack of equations specifically for use in older adults. There is also little evidence available regarding the effects of ageing on REE, although it is known that there is a reduction in metabolically active tissue which is likely to result in a decrease in REE. This study aims to develop and validate prediction equations which will result in more reliable estimates of REE in older adults. This will enable Dietitians to provide appropriate nutritional support and therefore optimise nutritional status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29826 0
Address 29826 0
Country 29826 0
Phone 29826 0
Fax 29826 0
Email 29826 0
Contact person for public queries
Name 13073 0
Dr Michelle Miller
Address 13073 0
Nutrition and Dietetics,
Flinders Clinical and Molecular Medicine,
School of Medicine,
Flinders University,
GPO Box 2100,
Adelaide,
SA 5001
Country 13073 0
Australia
Phone 13073 0
+61 8 8204-5328
Fax 13073 0
+61 8 8204-6406
Email 13073 0
[email protected]
Contact person for scientific queries
Name 4001 0
Dr Michelle Miller
Address 4001 0
Nutrition and Dietetics,
Flinders Clinical and Molecular Medicine,
School of Medicine,
Flinders University,
GPO Box 2100,
Adelaide,
SA 5001
Country 4001 0
Australia
Phone 4001 0
+61 8 8204-5328
Fax 4001 0
+61 8 8204-6406
Email 4001 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.