HealthyNCT03209817
Tomato Supplementation and Cardiovascular Health
A study testing Red cherry tomato and Yellow cherry tomato in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Red cherry tomato and Yellow cherry tomato
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male.
- Aged between 18-60.
- Healthy.
- Non smoker.
- Not taking antioxidant supplement.
- No known allergy or intolerance to tomato.
Who cannot join
- Female
- Aged below 18 or above 60 years old.
- Suffering and taking medications for hypertension (>140/90mmHg), diabetes, high blood cholesterol and heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome).
- Taking antioxidant supplements.
- Smoking.
- Allergy to tomato or tomato products.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
Newcastle upon Tyne, NE1 8ST
About this study
Official title: Effects of Tomato Supplementation on Cardiovascular Health
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Red cherry tomato, Yellow cherry tomato
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red cherry tomatoDietary supplement
300 grams of cherry tomatoes per day for four weeks (each)
Yellow cherry tomatoDietary supplement
300 grams of cherry tomatoes per day for four weeks (each)
| Study group | Role | What they receive |
|---|---|---|
| Red cherry tomato | Experimental | 300 grams of red cherry tomatoes per day for four weeks (each) Receives: Dietary Supplement: Red cherry tomato |
| Yellow cherry tomato | Experimental | 300 grams of yellow cherry tomatoes per day for four weeks (each) Receives: Dietary Supplement: Yellow cherry tomato |
| Control No tomato | No intervention | No tomato products consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation (FMD)
To assess macrovascular endothelial function.
Measured: at 4 weeks
Laser doppler imaging (LDI)
To assess the microvascular endothelial function.
Measured: at 4 weeks
Pulse wave velocity (PWV) and pulse wave analysis (PWA)
To assess arterial stiffness
Measured: at 4 weeks
Secondary outcomes (4)
Ambulatory blood pressure
24 hours blood pressure
Measured: at 4 weeks
Blood lipids
Total, LDL, HDL cholesterol and triglycerides
Measured: at 4 weeks
Interleukin-6 (IL-6)
Interleukin-6 (IL-6)
Measured: at 4 weeks
C-reactive protein (CRP)
C-reactive protein (CRP)
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start23 Jan 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Lara Gallegos, Northumbria University
- Investigators
- Jose Lara, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209817
- Sponsor's protocol ID
- HLS-JLG-03-07-17
- Status last verified
- Apr 2018
- First submitted
- 3 Jul 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng HM, Koutsidis G, Lodge JK, Ashor A, Siervo M, Lara J. Tomato and lycopene supplementation and cardiovascular risk factors: A systematic review and meta-analysis. Atherosclerosis. 2017 Feb;257:100-108. doi: 10.1016/j.atherosclerosis.2017.01.009. Epub 2017 Jan 13.
PubMed 28129549
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tomato Supplementation on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT03209817
- Acronym / sponsor ID
- HLS-JLG-03-07-17
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red cherry tomato | Experimental | Dietary Supplement: Red cherry tomato300 grams of red cherry tomatoes per day for four weeks (each) |
| Yellow cherry tomato | Experimental | Dietary Supplement: Yellow cherry tomato300 grams of yellow cherry tomatoes per day for four weeks (each) |
| Control No tomato | No intervention | –No tomato products consumption |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male.
- Aged between 18-60.
- Healthy.
- Non smoker.
- Not taking antioxidant supplement.
Key exclusion criteria (6 listed)
- Female
- Aged below 18 or above 60 years old.
- Suffering and taking medications for hypertension (>140/90mmHg), diabetes, high blood cholesterol and heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome).
- Taking antioxidant supplements.
- Smoking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red cherry tomato300 grams of cherry tomatoes per day for four weeks (each) | Dietary supplement | Red cherry tomato |
| Yellow cherry tomato300 grams of cherry tomatoes per day for four weeks (each) | Dietary supplement | Yellow cherry tomato |
Primary outcome
Flow mediated dilation (FMD)
Time frame: at 4 weeks
To assess macrovascular endothelial function.
Laser doppler imaging (LDI)
Time frame: at 4 weeks
To assess the microvascular endothelial function.
Pulse wave velocity (PWV) and pulse wave analysis (PWA)
Time frame: at 4 weeks
To assess arterial stiffness
4 secondary outcomes
Ambulatory blood pressure
Time frame: at 4 weeks
Blood lipids
Time frame: at 4 weeks
Interleukin-6 (IL-6)
Time frame: at 4 weeks
C-reactive protein (CRP)
Time frame: at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Background: PubMed 28129549Cheng HM, Koutsidis G, Lodge JK, Ashor A, Siervo M, Lara J. Tomato and lycopene supplementation and cardiovascular risk factors: A systematic review and meta-analysis. Atherosclerosis. 2017 Feb;257:100-108. doi: 10.1016/j.atherosclerosis.2017.01.009. Epub 2017 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Lara, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red cherry tomato and Yellow cherry tomato in people with Healthy, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow mediated dilation (FMD) (time frame: at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.