An interventional study of Red cherry tomato and Yellow cherry tomato in Healthy, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Northumbria University · Not applicable, Interventional, and Prevention
This clinical trial aims to test the effects of consuming two types of tomato (one ordinary cherry red tomato containing lycopene, and the other a yellow cherry tomato low in lycopene), on cardiovascular risk factors including endothelial function as the primary outcome, and blood lipids, inflammatory factors and blood pressure.
In a crossover design, participants of this study will randomly consume 300g of raw cherry (red and yellow) tomatoes per day for four weeks, with a control period consuming no tomato products. Before and after each intervention, the cardiovascular outcomes mentioned above will be measured in the clinic.
This study will have a randomised and crossover design of 2 interventions supplementing 300g/day of two different varieties of tomato; each of these interventions will last for 4 weeks, with a control period (no tomato consumption) of 4 weeks between these. The total study period will be 12 weeks. The target sample size for this study is 30 male participants. This study visit involve 4 study visits over a 12-week period plus a screening visit before the intervention.
In this study, the interventions will require participants to consume two different varieties of fresh tomatoes in random order. Participants will be given all the tomato to be consumed during the study, and will be instructed not to consume additional tomato sources. The amount of tomato to be consumed will be delivered every week. Participants will consume the tomatoes anytime as snack or with meal. In order to control for other dietary factors, participants will also be asked to record food diary throughout the first study period (4 weeks) and will be recommended to repeat their own dietary pattern for the control period and second study period to match up the food and nutrition intake throughout the whole study. They should not alter their usual diet and exercise patterns when completing the food diary or study. Before and after each 4 weeks intervention or control period, participant will attend the study visit for measurements.
Baseline measurements will be taken at the start of the first study period. All measurements will be measured at fasted state on before and after 4-week study period. Anthropometric measurements including height and weight, a total of 72ml venous blood samples (18ml each measurement) will be collected by researcher. Spot urine and saliva samples will be collected into a flask provided by participants themselves. Plasma and urine analyses will not commence until the full intervention study is complete, and all samples from each subject are analysed within one batch to reduce inter-batch variation. Trained researchers will obtain blood sample in this study.
Before the start of the trial, 4 volunteers will be recruited to consume 1 week of 300g red cherry tomato per day for 7 days in order to establish expected serum levels of lycopene after tomato supplementation. The aim of this is to develop cut-off serum levels to establish compliance with interventions. Six ml of fasting blood will be taken at baseline and after the 1 week consumption of red cherry tomato.
Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
300 grams of red cherry tomatoes per day for four weeks (each)
Dietary Supplement: Red cherry tomato
300 grams of yellow cherry tomatoes per day for four weeks (each)
Dietary Supplement: Yellow cherry tomato
No tomato products consumption
300 grams of cherry tomatoes per day for four weeks (each)
300 grams of cherry tomatoes per day for four weeks (each)
Flow mediated dilation (FMD)
To assess macrovascular endothelial function.
Time frame: at 4 weeks
Laser doppler imaging (LDI)
To assess the microvascular endothelial function.
Time frame: at 4 weeks
Pulse wave velocity (PWV) and pulse wave analysis (PWA)
To assess arterial stiffness
Time frame: at 4 weeks
Ambulatory blood pressure
24 hours blood pressure
Time frame: at 4 weeks
Blood lipids
Total, LDL, HDL cholesterol and triglycerides
Time frame: at 4 weeks
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Time frame: at 4 weeks
C-reactive protein (CRP)
C-reactive protein (CRP)
Time frame: at 4 weeks
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Northumbria University