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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]

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

Condition category

Condition code

Diet and Nutrition

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]

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]

Preliminary study- To determine the appearance of tetra-cis-lycopene in plasma during the 48 hours since consuming golden tomatoes.

Timepoint [1]

Preliminery study- 0, 4, 8, 12, 16, 24, 26, 28, 30, 32, 34 and 48 hours after the tomato meal.

Primary outcome [2]

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]

Main Study- 0, 4, 8, 24, 28, 34 and 48 hours after the tomato meal.

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Manawatu

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heritage Food Crops Research Trust

Address [1]

PO Box 4088
Wanganui
New Zealand
4541

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Health and Disability Ethics committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon 
WELLINGTON 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

13/03/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Lycopene is a carotenoid, present in tomatoes and other coloured fruit (water melon, guava, papaya) and vegetables (sweet potato, carrot, pumpkin), that has been linked to beneficial effects on human health, such as prevention and reduction of cancer and heart disease (Friedman 2013).  Dietary sources of lycopene are mostly the trans isomer, while the form of lycopene found in human blood, plasma and tissues is the more bioavailable cis isomer of lycopene. 
Red tomatoes are a common dietary source of trans isomer lycopene. When they are cooked, some of the naturally-present trans isomers are converted to cis isomers which are more readily absorbed, resulting in increased lycopene absorption (Unlu et al. 2007). 
More recently, some tangerine (also known as golden) tomato varieties have been found to be naturally rich in tetra-cis-lycopene (McGhie et al. 2014). This study examined the absorption of lycopene from raw tomatoes in thirteen healthy human volunteers over 24 hours and found that more tetra-cis-lycopene from tangerine tomatoes was absorbed than all-trans-lycopene from red tomatoes, indicating a greater bioavailability of tetra-cis-lycopene. In addition, because the tangerine tomatoes’ lycopene can be accessed in the raw fruit, loss of other nutrients during processing is avoided.
A preliminary study will be undertaken to determine if tetra-cis-lycopene persists in the blood of volunteers beyond the 24 hours established in the first study. These participants will consume the tetra-cis-lycopene-rich tangerine tomatoes and blood samples taken up to 48 hours after this tomato meal. In the main study, the level of lycopene in the plasma of volunteers who have consumed tetra-cis-lycopene-rich tangerine tomatoes will be compared with the level following consumption of standard red tomatoes, in a cross over intervention clinical study. 
1. Friedman, M. 2013. 'Anticarcinogenic, Cardioprotective, and Other Health Benefits of Tomato Compounds Lycopene, alpha-Tomatine, and Tomatidine in Pure Form and in Fresh and Processed Tomatoes', Journal of Agricultural and Food Chemistry, 61: 9534-50.
2. 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." Confidential report. Palmerston North: Plant & Food Research.
3. Unlu, N. Z., T. Bohn, D. M. Francis, H. N. Nagaraja, S. K. Clinton, and S. J. Schwartz. 2007. 'Lycopene from heat-induced cis-isomer-rich tomato sauce is more bioavailable than from all-trans-rich tomato sauce in human subjects', British Journal of Nutrition, 98: 140-46.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Christine Butts

Address

The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442

Country

New Zealand

Phone

+6463556147

Fax

+6463517050

Chrissie.Butts@plantandfood.co.nz

Contact person for public queries

Name

Christine Butts

Address

The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442

Country

New Zealand

Phone

+6463556147

Fax

+6463517050

Chrissie.Butts@plantandfood.co.nz

Contact person for scientific queries

Name

Christine Butts

Address

The New Zealand Institute for Plant and Food Research
Private Bag 11 600
Palmerston North
4442

Country

New Zealand

Phone

+6463556147

Fax

Chrissie.Butts@plantandfood.co.nz

No information has been provided regarding IPD availability

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No Supporting Document Provided

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