None listed
Conditions
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.
Interventions
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 o
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).
Sponsors
Heritage Food Crops Research Trust
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
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
Outcome results
None listed