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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?
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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
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Secondary ID [1]
283101
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Nil known
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Universal Trial Number (UTN)
U1111-1147-2894
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Micronutrient status in blood
289941
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Condition category
Condition code
Diet and Nutrition
290315
290315
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287818
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Prevention
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Comparator / control treatment
Active comparator- tomato containing standard lycopene
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Control group
Active
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Outcomes
Primary outcome [1]
290352
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Lycopene presence in blood following consumption of tomato
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Assessment method [1]
290352
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Timepoint [1]
290352
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0, 4, 5 and 6 hours
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Secondary outcome [1]
304349
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Lycopene presence in urine
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Assessment method [1]
304349
0
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Timepoint [1]
304349
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0 and 24 hours
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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)
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Bio-availability
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/11/2013
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Actual
13/01/2014
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Date of last participant enrolment
Anticipated
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Actual
28/02/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
12
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Recruitment outside Australia
Country [1]
5345
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New Zealand
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State/province [1]
5345
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Palmerston North
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Funding & Sponsors
Funding source category [1]
287856
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Charities/Societies/Foundations
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Name [1]
287856
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Central Tree Crops Research Trust
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Address [1]
287856
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Central Tree Crops Research Trust
P.O. Box 4088
Wanganui
New Zealand
4541
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Country [1]
287856
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New Zealand
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Primary sponsor type
Government body
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Name
The New Zealand Institute of Plant and Food Research
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Address
The New Zealand Institute of Plant and Food Research
Private Bag 11 600
Palmerston North
4442
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Country
New Zealand
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Secondary sponsor category [1]
286585
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Charities/Societies/Foundations
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Name [1]
286585
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Central Tree Crops Research Trust
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Address [1]
286585
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Central Tree Crops Research Trust
P.O. Box 4088
Wanganui
New Zealand
4541
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Country [1]
286585
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289798
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Health and Disability Ethics Committees
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Ethics committee address [1]
289798
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Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6145
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Ethics committee country [1]
289798
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New Zealand
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Date submitted for ethics approval [1]
289798
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16/09/2013
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Approval date [1]
289798
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11/12/2013
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Ethics approval number [1]
289798
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13/CEN/164 approved 11 Dec 2013
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
42494
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Dr Kerry Bentley-Hewitt
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Address
42494
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The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
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Country
42494
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New Zealand
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Phone
42494
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+64 6 3556215
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Fax
42494
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Email
42494
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[email protected]
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Contact person for public queries
Name
42495
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Mrs Sarah Eady
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Address
42495
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The New Zealand Institute for Plant and Food Research
Canterbury agriculture and Science Centre
Gerald Street
Lincoln
7608
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Country
42495
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New Zealand
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Phone
42495
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+64 6 3259671
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Fax
42495
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Email
42495
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[email protected]
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Contact person for scientific queries
Name
42496
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Dr Kerry Bentley-Hewitt
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Address
42496
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The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
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Country
42496
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New Zealand
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Phone
42496
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+64 6 3556215
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Fax
42496
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Email
42496
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[email protected]
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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.
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