Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000998842
Ethics application status
Approved
Date submitted
11/09/2012
Date registered
18/09/2012
Date last updated
6/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Does consumption of micronutrient rich vegetables improve micronutrient levels in healthy adults?.
Scientific title
Does consumption of micronutrient rich vegetables improve micronutrient levels in the blood of healthy adults? Non-randomised single group study.
Secondary ID [1] 281188 0
none
Universal Trial Number (UTN)
U1111-1134-4609
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micronutrient status in blood 287364 0
Condition category
Condition code
Diet and Nutrition 287694 287694 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is, once daily consumption of 100g of micronutrient rich vegetable (e.g broccoli) for 3 consecutive days. A blood sample will be obtained at 0,24 and 72 hour time points.
There will be a 72 hour washout period between the intervention and the active control treatment.
Intervention code [1] 285648 0
Treatment: Other
Intervention code [2] 285683 0
Prevention
Comparator / control treatment
Active Comparator- non-micronutrient enriched vegetable (e.g. Broccoli)
Control group
Active

Outcomes
Primary outcome [1] 287943 0
Micronutrient status in blood following the consumption of micronutrient rich vegetables.
Timepoint [1] 287943 0
0, 24 and 72 hours
Secondary outcome [1] 299098 0
Immuno modulation of gene expression in peripheral blood, following consumption of micronutrient rich vegetables.
Timepoint [1] 299098 0
0, 24 and 72 hours

Eligibility
Key inclusion criteria
Healthy young adults
Minimum age
25 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People taking regular medications including micronutrient suppliments, antacids, laxatives, hay-fever medications and any prescribed medicine will be excluded. Also, people who had a hysterectomy,have asthma, have taken antibiotics within 4 weeks before the study start date and have donated blood within 16 weeks before the study start date will be excluded. Smokers will be excluded.

Study design
Purpose of the study
Prevention
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
Other
Other design features
All patients receive the treatments in the same order: 3 consecutive days of non-mocronutrient enriched control vegetables (100g, once daily), followed by a 72 hour washout period, and then 3 consecutive days of mocronutrient enriched control vegetables (100g, once daily).
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
29/03/2013
Date of last data collection
Anticipated
Actual
19/04/2013
Sample size
Target
16
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 4539 0
New Zealand
State/province [1] 4539 0
Palmerston North

Funding & Sponsors
Funding source category [1] 285966 0
Government body
Name [1] 285966 0
New Zealand Institute for Plant and Food Research
Country [1] 285966 0
New Zealand
Primary sponsor type
Government body
Name
New Zealand Institute for Plant and Food Research
Address
Private bag 11 600
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 284790 0
None
Name [1] 284790 0
Address [1] 284790 0
Country [1] 284790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287997 0
Health and diability ethics committee
Ethics committee address [1] 287997 0
1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 287997 0
New Zealand
Date submitted for ethics approval [1] 287997 0
03/10/2012
Approval date [1] 287997 0
05/11/2012
Ethics approval number [1] 287997 0
12/CEN/56

Summary
Brief summary
Micronutrients are of fundamantal importance to human health. It is possible to grow vegetables enriched with micronutrients, resulting in unique micronutrient-containing compounds which may enhance their roles in supporting human health. We aim to assess uptake of micronutrients into blood following a daily consumption of micronutrient rich vegetable for 3 days. The study design will establish natural variation in baseline levels of micronutrient prior to feeding, and then will compare levels at both 1 and 3 days following daily consumption of 100g micronutrient rich vegetable. In addition, we aim to further our knowledge into understanding human health.
Trial website
Trial related presentations / publications
Consumption of selenium-enriched broccoli increases cytokine production in human peripheral blood mononuclear cells stimulated ex vivo, a preliminary human intervention study-Journal of Molecular Nutrition and Food Research, 58(12) · December 2014 Kerry L Bentley-Hewitt, Ronan Chen, Ross Lill, Duncan Hedderley, Thanuja D Herath, Adam Matich and Marian McKenzie.
Public notes

Contacts
Principal investigator
Name 34685 0
Dr Juliet Ansell
Address 34685 0
Plant and Food Research Private Bag 11 600 Palmerston North 4442
Country 34685 0
New Zealand
Phone 34685 0
+6463556108
Fax 34685 0
Email 34685 0
[email protected]
Contact person for public queries
Name 17932 0
Ms Sarah Eady
Address 17932 0
Plant and Food Research
Canterbury agriculture and science centre
Gerald Street
Lincoln 7608
Country 17932 0
New Zealand
Phone 17932 0
+64-3-3259671
Fax 17932 0
+64-3-3252074
Email 17932 0
[email protected]
Contact person for scientific queries
Name 8860 0
Dr Dr. Kerry Bentley-Hewitt
Address 8860 0
Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 8860 0
New Zealand
Phone 8860 0
+64-6-3526215
Fax 8860 0
+64-6-351 7050
Email 8860 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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