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Trial registered on ANZCTR


Registration number
ACTRN12613000965707
Ethics application status
Approved
Date submitted
28/08/2013
Date registered
30/08/2013
Date last updated
27/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does lycopene bioavailability improve in tomatoes with novel lycopene compounds?
Scientific title
Bioavailability of novel lycopene compounds found in a variety of tomato - Analysing the uptake of lycopene in human blood of healthy adult volunteers- a randomised cross over group study
Secondary ID [1] 283101 0
Nil known
Universal Trial Number (UTN)
U1111-1147-2894
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micronutrient status in blood 289941 0
Condition category
Condition code
Diet and Nutrition 290315 290315 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is, consumption of one dose of tomato, containing 5-20 mg of novel tetra-cis lycopene or containing 5-20 mg standard trans-lycopene. A blood sample will be obtained at 0, 4, 5 and 6 hours and a urine sample will be obtained at 0 and 24 h. There will be a 2 week wash out peroid before consumption of one dose of the altenative variety of tomato. Samples are collected as with the first dose.
Intervention code [1] 287818 0
Prevention
Comparator / control treatment
Active comparator- tomato containing standard lycopene
Control group
Active

Outcomes
Primary outcome [1] 290352 0
Lycopene presence in blood following consumption of tomato
Timepoint [1] 290352 0
0, 4, 5 and 6 hours
Secondary outcome [1] 304349 0
Lycopene presence in urine
Timepoint [1] 304349 0
0 and 24 hours

Eligibility
Key inclusion criteria
Healthy adults

Pre-screened for normal blood lipid profiles (fasting cholesterol less than 5.2 nmol/L and fasting Plasma-triacylglycerol (TAG) rich lipoprotein Less than 2.3 nmol/L)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smokers,
Frequent alcohol consumption
Pregnant women,
Regular prescribed medication affecting lipid metabolism,
Regular use of carotenoid containing supplements,
BMI under18.5 or over 35,
Long term illness requiring active treatment (cancer, gastrointestinal disease, cardiovascular disease, diabetes)
Regular use of antacids and laxatives (more than once a week),
Not willing to discontinue foods containing tomato, guava, watermelon, grapefruit, dried parsley or basil, persimmons, liver pate, asparagus, red cabbage, chillies, papaya or carotenoid containing supplements, laxatives and antacids 1 week prior to and during the trial period.
Have donated blood within 16 wk of first sample,
Has taken antibiotics within 4 weeks before study start date.
Fasting cholesterol greater than 5.2 mmol/L and fasting Plasma-triacylglycerol (TAG) rich lipoprotein greater than 2.3 mmol/L.

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)
Once assigned to the study, participants will be asked to draw a code from a box containing equal numbers of 2 codes (totalling the amount of participants in the trial). These codes will be given to the research coordinator whom has previously allocated the codes to the 2 varieties of tomato. The tomato variety each participant selects is the variety they will be given first. Participants will consume their tomato diced in a booth and asked not to discuss the fruit with other participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be asked to draw a code from a box containing equal numbers of 2 codes (totalling the amount of participants in the trial).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5345 0
New Zealand
State/province [1] 5345 0
Palmerston North

Funding & Sponsors
Funding source category [1] 287856 0
Charities/Societies/Foundations
Name [1] 287856 0
Central Tree Crops Research Trust
Address [1] 287856 0
Central Tree Crops Research Trust
P.O. Box 4088
Wanganui
New Zealand
4541
Country [1] 287856 0
New Zealand
Primary sponsor type
Government body
Name
The New Zealand Institute of Plant and Food Research
Address
The New Zealand Institute of Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country
New Zealand
Secondary sponsor category [1] 286585 0
Charities/Societies/Foundations
Name [1] 286585 0
Central Tree Crops Research Trust
Address [1] 286585 0
Central Tree Crops Research Trust
P.O. Box 4088
Wanganui
New Zealand
4541
Country [1] 286585 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289798 0
Health and Disability Ethics Committees
Ethics committee address [1] 289798 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145
Ethics committee country [1] 289798 0
New Zealand
Date submitted for ethics approval [1] 289798 0
16/09/2013
Approval date [1] 289798 0
11/12/2013
Ethics approval number [1] 289798 0
13/CEN/164 approved 11 Dec 2013

Summary
Brief summary
Lycopene is a carotenoid, present in tomatoes, which has linked to beneficial effects on human health, such as prevention of prostate cancer. Lycopene found in human blood, plasma and tissues contain high levels of cis isomers of lycopene, whereas the trans isomer is the main dietary source of lycopene. Interestingly, processing of tomatoes converts trans isomers to cis isomers and the latter being regarded as more bioavailable, since they are more soluble and better absorbed in the gut. Although it should be noted that isomerisation may also take place in vivo. Processing of food can lead to loss of beneficial nutrients and therefore being able to consume fresh unprocessed tomatoes rich in cis isomer lycopene rather than a processed tomato product may provide additional nutritional benefits.
Trial website
Trial related presentations / publications
Bentley-Hewitt K. L., Chen R. K-Y., Lill R. E., Hedderley D. I., Herath T.D., Matich A. J., McKenzie M. J. (2014) Consumption of selenium-enriched broccoli increases cytokine production in human peripheral blood mononuclear cells stimulated ex vivo, a preliminary human intervention study. Molecular Nutrition & Food Research.
Public notes

Contacts
Principal investigator
Name 42494 0
Dr Kerry Bentley-Hewitt
Address 42494 0
The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 42494 0
New Zealand
Phone 42494 0
+64 6 3556215
Fax 42494 0
Email 42494 0
kerry.bentley-hewitt@plantandfood.co.nz
Contact person for public queries
Name 42495 0
Mrs Sarah Eady
Address 42495 0
The New Zealand Institute for Plant and Food Research
Canterbury agriculture and Science Centre
Gerald Street
Lincoln
7608
Country 42495 0
New Zealand
Phone 42495 0
+64 6 3259671
Fax 42495 0
Email 42495 0
sarach.eady@plantandfood.co.nz
Contact person for scientific queries
Name 42496 0
Dr Kerry Bentley-Hewitt
Address 42496 0
The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 42496 0
New Zealand
Phone 42496 0
+64 6 3556215
Fax 42496 0
Email 42496 0
kerry.bentley-hewitt@plantandfood.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary