Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000422325p
Ethics application status
Submitted, not yet approved
Date submitted
14/03/2017
Date registered
24/03/2017
Date last updated
24/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Lycopene bioavailability in red and golden tomatoes.
Scientific title
Bioavailability of tetra-cis-lycopene compounds found in some heritage golden tomatoes measured in healthy volunteers – a cross over study
Secondary ID [1] 291434 0
HT-2017-1001
Universal Trial Number (UTN)
U1111-1193-7772
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Micro-nutrient status in blood 302458 0
Condition category
Condition code
Diet and Nutrition 302020 302020 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preliminary trial- All participants (n=2) will receive one serve of freshly sliced golden tomatoes containing 30 mg of tetra-cis lycopene as breakfast on 2 pieces of toast with 15 ml of olive oil . Participants will be asked to consume the tomato meal within 15 minutes.

Main study (cross over study) -In treatment period 1 (TP1) all participants (n=20) will receive one serve of freshly diced golden tomatoes containing 30 mg of tetra-cis lycopene as breakfast (on 2 pieces of toast with 15 ml of olive oil) . After two weeks of wash out period In treatment period 2 (TP2) all participants will receive one serve of freshly sliced red tomatoes containing 30 mg of standard trans-lycopene as breakfast on 2 pieces of toast with 15 ml of olive oil.. In both treatment periods participants will be asked to consume the tomato meal within 15 minutes.
Intervention adherence will be assessed by the trial coordinating researcher/s at each visit by weighing uneaten study treatment. All doses taken by the subject and all dose changes during the study must be recorded on the CRF (case report form).
Intervention code [1] 297471 0
Prevention
Comparator / control treatment
Active comparator treatment will be red tomatoes containing the same amount of trans lycopene i.e. 30 mg This is only for the main study.
Control group
Active

Outcomes
Primary outcome [1] 301449 0
Preliminary study- To determine the appearance of tetra-cis-lycopene in plasma during the 48 hours since consuming golden tomatoes.
Timepoint [1] 301449 0
Preliminery study- 0, 4, 8, 12, 16, 24, 26, 28, 30, 32, 34 and 48 hours after the tomato meal.
Primary outcome [2] 301478 0
Main study- To determine the appearance of tetra-cis-lycopene and standard trans lycopene in the plasma during the 48 hours since consuming golden and red tomatoes.
Timepoint [2] 301478 0
Main Study- 0, 4, 8, 24, 28, 34 and 48 hours after the tomato meal.
Secondary outcome [1] 332702 0
Main study- To explore the effect of tetra-cis-lycopene and standard trans-lycopene in human plasma on the anti-proliferative responses in prostate cancer cell lines in cell culture assays. Therefore the outcome is assessed by measuring the growth or reduction in cultured cancer cells treated with plasma.
Timepoint [1] 332702 0
Main study- 0, 4, 8, 24, 28, 34, 48 hours after the tomato meal

Eligibility
Key inclusion criteria
Please note the inclusion criteria are identical for preliminary and main studies.
Pre-screened for blood lipid profiles (fasting cholesterol less than 5.2 mmol/L and fasting plasma-triglycerol (TAG) rich lipoprotein less than 2.3 mmol/L and
1. Adults aged 18 to 65 years of age inclusive.
2. Subjects must be non-smoking (no use of tobacco products in the previous 3 months).
3. Subjects must have a body mass index (BMI) within the range of 18.5 to 25 kg/m2 inclusive at screening.
4. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
5. Subjects must be willing to discontinue foods containing tomato, sweet potato/kumara, carrots, pumpkin, 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.
6. Subjects must be free of chronic disease (cardiovascular disease, cancer, renal failure, previous gastrointestinal surgery (not including appendectomy or cholecystectomy)), gastrointestinal conditions such as peptic/duodenal ulcers, Crohns disease and IBS, or neurological conditions (e.g. multiple sclerosis, spinal cord injury, stroke).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Please note the exclusion criteria are identical for preliminary and main studies.
1. Smokers
2. Frequent alcohol consumption (more than 21 units/week for males and more than 14 units for females)
3. Pregnant or breast feeding women, or women actively trying to conceive
4. Regular prescribed medication affecting lipid metabolism
5. Regular use of carotenoid containing supplements
6. BMI under 18.5 or over 25
7. Long term illness requiring active treatment (cancer, gastrointestinal disease, cardiovascular disease, diabetes)
8. Regular use of antacids, proton pump inhibitors, laxatives other medication that may affect digestion (more than once a week)
9. 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.
10. Have donated blood within 4 weeks of first proposed sample
11. Has taken antibiotics within 4 weeks of study start date.
12. 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not appicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
A preliminary study of single group design (n=2) is also included as part of this study.
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
In our previous study (ACTRN12613000965707), we tested the bioavailability of Lycopene from tomatoes (n=13) and found relatively consistent patterns using 4 time points ( 0, 4, 7 and 24) within 24 hours (McGhie et al., 2014).
For this preliminary study we hope to get more information on the time course of lycopene bioavailability in plasma by sampling at 12 time points over 48 hours ( 0, 4, 8, 12, 16, 24, 26, 28, 30, 32, 34 and 48 hours). Given the consistency of the previous results, and the extra discomfort from the extra blood samples, we have chosen to study only two people to confirm the 48 hour time course.
The study is designed to detect a significant difference in lycopene concentration (ng/mL) in the plasma of healthy adults. A power calculation has been completed using the data from the previous study on lycopene bioavailability carried out at Plant & Food Research (McGhie et al. 2014).
To reliably detect (i.e. power of 80% with a p=0.05 two-tailed test) the biggest difference we have seen (30 ng/mL, at 24 hr) in a cross over design would require 5 subjects; to reliably detect a smaller difference (say half that, 15 ng/mL, which we might need to show differences over time) would require 18 subjects. To allow for participants not completing the study, we will recruit 20 participants.
Reference:
McGhie, T., K. Bentley-Hewitt, T. D. Herath, H. Smith, S. Martell, and S. Middlemiss-Kraak. 2014. "The bioavailability of tetra-cis-lycopene in humans and tetra-cis lycopene concentrations in selections of heritage tomatoes." In Confidential report,Plant & Food Research, Palmerston North.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
14/04/2017
Actual
Date of last data collection
Anticipated
16/06/2017
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 8738 0
New Zealand
State/province [1] 8738 0
Manawatu

Funding & Sponsors
Funding source category [1] 295901 0
Charities/Societies/Foundations
Name [1] 295901 0
Heritage Food Crops Research Trust
Country [1] 295901 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Heritage Food Crops Research Trust
Address
PO Box 4088
Wanganui
New Zealand
4541
Country
New Zealand
Secondary sponsor category [1] 294779 0
None
Name [1] 294779 0
Address [1] 294779 0
Country [1] 294779 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 297182 0
Health and Disability Ethics committee
Ethics committee address [1] 297182 0
Ethics committee country [1] 297182 0
New Zealand
Date submitted for ethics approval [1] 297182 0
13/03/2017
Approval date [1] 297182 0
Ethics approval number [1] 297182 0

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

Contacts
Principal investigator
Name 73254 0
Dr Christine Butts
Address 73254 0
The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 73254 0
New Zealand
Phone 73254 0
+6463556147
Fax 73254 0
+6463517050
Email 73254 0
[email protected]
Contact person for public queries
Name 73255 0
Christine Butts
Address 73255 0
The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 73255 0
New Zealand
Phone 73255 0
+6463556147
Fax 73255 0
+6463517050
Email 73255 0
[email protected]
Contact person for scientific queries
Name 73256 0
Christine Butts
Address 73256 0
The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442
Country 73256 0
New Zealand
Phone 73256 0
+6463556147
Fax 73256 0
Email 73256 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

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