Trial Review

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
ACTRN12607000187448
Ethics application status
Approved
Date submitted
28/03/2007
Date registered
30/03/2007
Date last updated
19/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of skim milk products on serum uric acid levels
Scientific title
The effect of skim milk products on serum uric acid levels for the prevention of gout
Secondary ID [1] 287939 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum uric acid lowering in the prevention of gout 1705 0
Condition category
Condition code
Metabolic and Endocrine 1797 1797 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a short term crossover study. Each participant will receive a single dose of each of the following products, each in a different order. Each product will be given orally at a standard dose of 80g protein in 800ml of water. Participants will attend four study visits, each at least one week apart, over an eight week period. The following products will be tested:
Control agent: soy protein (Code number 06/8040/1668)
Study agents: three skim milk products (Code numbers 01/7939/1274, 03/7939/1276, and 07/000/1275).
Intervention code [1] 1673 0
Treatment: Other
Comparator / control treatment
Control agent: soy protein (Code number 06/8040/1668)
Control group
Active

Outcomes
Primary outcome [1] 2518 0
Change in serum uric acid lowering
Timepoint [1] 2518 0
At three hours after the administration of the soy and skim milk products.
Secondary outcome [1] 4339 0
1. Change in urea concentration
Timepoint [1] 4339 0
At 3 hours after the administration of the soy and skim milk products.
Secondary outcome [2] 4340 0
2. Area under curve over time (0 to 3 hours) for serum uric acid after the administration of the soy and skim milk products.
Timepoint [2] 4340 0
At 3 hours after the administration of the soy and skim milk products
Secondary outcome [3] 4341 0
3. Area under curve over time (0 to 3 hours) for urea after the administration of the soy and skim milk products.
Timepoint [3] 4341 0
At 3 hours after the administration of the soy and skim milk products

Eligibility
Key inclusion criteria
1.Able to provide written informed consent2.Willing to return for four study visits over eight weeks3.Normal renal function 4.Normal haemoglobin
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1.History of gout 2.History of diabetes mellitus 3.Diuretic use 4.History of lactose intolerance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participants and the investigators will be blinded to the order of the test substances. Each participant will be allocated the order of test substances off-site by the manufacturer. Test substances will be provided by the manufacturer in coded sealed sachets. Test substances will be pre-weighed into sachets labelled with individual 3-digit codes. The test substance order for each subject will be chosen at random and provided in sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each subject evaluates each test substance, but always in a different order. Orders were randomly allocated to subjects using a random number generator (Minitab Release 14.2). The test substance sachets will be labelled with unique 3-digit codes, which were randomly chosen from all 3-digit codes between 111 and 999 and allocated to the sachets (Minitab Release 14.2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The subjects, assessors and data analysts will be blinded to the treatment order.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2007
Actual
14/06/2007
Date of last participant enrolment
Anticipated
Actual
1/05/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 498 0
New Zealand
State/province [1] 498 0
Auckland

Funding & Sponsors
Funding source category [1] 1950 0
Commercial sector/Industry
Name [1] 1950 0
LactoPharma Consortium
Country [1] 1950 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
LactoPharma Consortium
Address
Auckland UniServices Ltd
Level 10, UniServices House,
70 Symonds Street, Auckland
Private Bag 92019, Victoria Street West,
Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 1762 0
None
Name [1] 1762 0
Nil
Address [1] 1762 0
Country [1] 1762 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3627 0
Northern X Regional Ethics committee
Ethics committee address [1] 3627 0
Ethics committee country [1] 3627 0
New Zealand
Date submitted for ethics approval [1] 3627 0
Approval date [1] 3627 0
02/05/2007
Ethics approval number [1] 3627 0

Summary
Brief summary
Recent studies have identified ingestion of dairy products as protective for the development of gout. This effect is likely to be due to the uric acid lowering effect of factors within milk. The proposed study will analyse the effect of specific skim milk products on uric acid levels in healthy men, in an attempt to understand how dairy products influence uric acid levels.
This is a cross-over pilot study of short term urate-lowering effects of skim milk powders. We will study 16 healthy male participants. Participants will attend four study visits, each lasting approximately four hours and on each visit will receive a milk product. Blood and urine samples will be taken over the four hour period. Participants will receive all four study products over an eight week period, but products will be administered in a random order.
Trial website
Trial related presentations / publications
http://ard.bmj.com/content/69/9/1677.long
Public notes

Contacts
Principal investigator
Name 27776 0
Prof Nicola Dalbeth
Address 27776 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton, Auckland 1023
New Zealand
Country 27776 0
New Zealand
Phone 27776 0
+64 (0) 9 9232568
Fax 27776 0
Email 27776 0
[email protected]
Contact person for public queries
Name 10862 0
Dr Anne Horne
Address 10862 0
Bone Research Group
Department of Medicine
University of Auckland
Park Rd, Grafton,
Auckland
Country 10862 0
New Zealand
Phone 10862 0
64 9 307 8970
Fax 10862 0
64 9 373 7677
Email 10862 0
[email protected]
Contact person for scientific queries
Name 1790 0
Prof Nicola Dalbeth
Address 1790 0
Bone Research Group
Department of Medicine
University of Auckland
Park Rd Grafton
Auckland
Country 1790 0
New Zealand
Phone 1790 0
64 9 3737999 x 82568
Fax 1790 0
Email 1790 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.