Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001147976
Ethics application status
Approved
Date submitted
27/10/2011
Date registered
2/11/2011
Date last updated
2/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dairy milk's potential as a functional food for improved cellular DNA integrity study
Scientific title
To determine whether consumption of cow milk improves the capacity of human cells to maintain integrity of their genetic material in healthy volunteers
Secondary ID [1] 273287 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Integrity of genetic material in healthy volunteers 279053 0
Condition category
Condition code
Public Health 279242 279242 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is a three week randomised crossover study investigating if consumption of cow milk improves the capacity of human cells to maintain integrity of their genetic material.
The study will involve three interventions (each drink once only) comparing the effect of 500ml reduced fat milk (2% fat) with that of 500ml orange juice and 500ml water.
Participant will be fasting overnight. The next morning they will donate first blood sample. Ten minutes later they will ingest 500ml of the assigned drink, which must be consumed within 5 minutes. More blood will be collected 1.5 hours, 3.0 hours and 4.5 hours after consumption of the drinks. There is 1-week wash-out period between each intervention.
Intervention code [1] 283635 0
Lifestyle
Comparator / control treatment
The study will involve three interventions comparing the effect of 500ml reduced fat milk (2% fat) with that of 500ml orange juice and 500ml water.
Control group
Placebo

Outcomes
Primary outcome [1] 279868 0
Radiation induced micronuclei in lymphocytes using cytokinesis blocked micronucleus (CBMN) assay.
Timepoint [1] 279868 0
At each of the three visits at time points 0hr, 1.5hr, 3hr and 4.5hrs after drinking either of the three test drinks
Primary outcome [2] 279895 0
Micronuclei in long term lymphocyte cultures using cytokinesis blocked micronucleus (CBMN) assay.
Timepoint [2] 279895 0
The plasma isolated from different points of the intervention will be used to detect its genome-protective effect in long-term (10 day) lymphocyte cultures using the micronucleus index in the CBMNcyt assay.
Secondary outcome [1] 294637 0
Plasma vitamin C will be measured using well established High Performance Liquid Chromatography (HPLC) method.
Timepoint [1] 294637 0
At each of the three visits at time points 0hr, 1.5hr, 3hr and 4.5hrs after drinking either of the three test drinks
Secondary outcome [2] 294716 0
Plasma calcium will be measured using Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES) methods.
Timepoint [2] 294716 0
At each of the three visits at time points 0hr, 1.5hr, 3hr and 4.5hrs after drinking either of the three test drinks

Eligibility
Key inclusion criteria
Healthy subjects aged 20-40 years
Not undergoing treatment for life-threatening diseases
Not taking vitamin or micronutrient supplements at doses that exceed 25% of the recommended dietary intake.
Consume less that 250ml of milk per day
Consume less than 100g of semi-solid (e.g. yoghurt) or solid dairy foods (e.g. cheddar cheese) per day
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to attend an information session and/or read the information sheet
Females who are planning a pregnancy or are pregnant
Current smokers
Those who drink more than two standard drinks of alcohol per day.
Body Mass Index 30 or greater
Diagnosed with diabetes
Lactose intolerance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284111 0
Commercial sector/Industry
Name [1] 284111 0
The Dairy Research Institute
Country [1] 284111 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
The Dairy Research Institute
Address
10255 W. Higggins Road
Suite 900
Rosemont, IL 60018-5616
Country
United States of America
Secondary sponsor category [1] 269073 0
Government body
Name [1] 269073 0
Commonwealth Scientific Industrial Research Organisation
Address [1] 269073 0
Food & Nutritional Sciences
Gate 13 Kintore Avenue
Adelaide SA 5000
Country [1] 269073 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272064 0
Commonwealth Scientific Industrial Research Organisation Human Research Ethics Committee
Ethics committee address [1] 272064 0
Gate 13 Kintore Avenue
Adelaide SA 5000
Ethics committee country [1] 272064 0
Australia
Date submitted for ethics approval [1] 272064 0
Approval date [1] 272064 0
29/09/2011
Ethics approval number [1] 272064 0

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

Contacts
Principal investigator
Name 33323 0
Address 33323 0
Country 33323 0
Phone 33323 0
Fax 33323 0
Email 33323 0
Contact person for public queries
Name 16570 0
Dr Varinder Dhillon
Address 16570 0
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 16570 0
Australia
Phone 16570 0
+61 8 83038932
Fax 16570 0
Email 16570 0
[email protected]
Contact person for scientific queries
Name 7498 0
Dr Michael Fenech
Address 7498 0
Gate 13 Kintore Avenue
Adelaide SA 5000
Country 7498 0
Australia
Phone 7498 0
+61 8 83038880
Fax 7498 0
Email 7498 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.