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Trial registered on ANZCTR


Registration number
ACTRN12608000021370
Ethics application status
Not yet submitted
Date submitted
24/05/2007
Date registered
16/01/2008
Date last updated
16/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Malnutrition, fuel utilisation and nocturnal carbohydrate supplementation in cirrhosis.
Scientific title
Fuel utilisation in people with cirrhosis measured by indirect calorimetry after nocturnal supplemention with complex carbohydrates compared to nocturnal supplementation with a high-energy, high-protein drink.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition in cirrhosis 2160 0
Condition category
Condition code
Diet and Nutrition 2255 2255 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a repeated measures study where all participants will be in all conditions. There are 3 study visits with a washout period of 6 nights between visits. The study supplement is given on one occasion only the night before Visit 3. The study supplement consists of 350ml low fat soy milk with 3 tbspns cornflour, 16g Poly-joule powder (glucose polymer, Nutricia).
Intervention code [1] 1782 0
Treatment: Other
Comparator / control treatment
Each comparator supplement will be consumed on one occasion only. The night before Visit 1, the participants will have a high protein snack according to their preference as discussed with the study dietitian. The night before Visit 2 (following a 6 night washout period) the participants will drink 200ml Ensure Plus (Abbott Australasia) a high protein/high energy sip supplement. A 6 night washout period will follow Visit 2 before the study supplement is administered the night before Visit 3.
Control group
Active

Outcomes
Primary outcome [1] 3730 0
Fuel utilisation measured by indirect calorimetry.
Timepoint [1] 3730 0
10 - 12 hours after the participants consume the snack or supplement fuel utilisation is measured by indirect calorimetry. This will be measured at each study visit
Secondary outcome [1] 6298 0
Nitrogen balance.
Timepoint [1] 6298 0
Nitrogen balance is calculated from food diary analysis (using FoodWorks V4 software) and 24hour urinary nitrogen. A food diary is kept for the week preceding each study visit. A 24 hour urine collection is made preceding each study visit and analysed for urinary nitrogen using Kjeldahl technique.

Eligibility
Key inclusion criteria
Cirrhosis
Minimum age
17 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Conditions that alter fuel utilisation and energy expenditure such as malignancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 733 0
2050

Funding & Sponsors
Funding source category [1] 2977 0
Government body
Name [1] 2977 0
National Health & Medical Research Council
Country [1] 2977 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 2686 0
None
Name [1] 2686 0
Address [1] 2686 0
Country [1] 2686 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4932 0
SSWAHS (RPA Zone)
Ethics committee address [1] 4932 0
Ethics committee country [1] 4932 0
Australia
Date submitted for ethics approval [1] 4932 0
30/03/2007
Approval date [1] 4932 0
Ethics approval number [1] 4932 0
X07-0105

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27885 0
Address 27885 0
Country 27885 0
Phone 27885 0
Fax 27885 0
Email 27885 0
Contact person for public queries
Name 10971 0
Rosemary Carney
Address 10971 0
AW Morrow GE and Liver Centre
Level 9 Bulding 75
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 10971 0
Australia
Phone 10971 0
+61 2 95157920
Fax 10971 0
+61 2 95155182
Email 10971 0
rosemary.carney@email.cs.nsw.gov.au
Contact person for scientific queries
Name 1899 0
Joanne Heyman
Address 1899 0
Department of Nutrition and Dietetics
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1899 0
Australia
Phone 1899 0
+61 2 95157897
Fax 1899 0
+61 2 95155182
Email 1899 0
joanne.heyman@sswahs.nsw.gov.au

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.