Cardiovascular DiseasesTomasaNCT02986165
Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation
A study testing Low dose pomace extract and High dose pomace extract in people with Cardiovascular Diseases, run by Centro de Estudios en Alimentos Procesados at 1 site in Chile.
Trial summary
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Low dose pomace extract and High dose pomace extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteChile
- Study dates
- Sep 2016to Dec 2017
- 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 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy men aged between 18 and 26 years
- BMI >19.5 and <26.0
- Platelet aggregation response corresponding to ≥ 65%
Who cannot join
- Known tomato allergy
- Chronic medical conditions requiring active treatment (e.g. cardiovascular disease, diabetes, asthma)
- Gastro-intestinal disease/disorders
- Smokers
- Medically prescribed medication known to affect platelet function
- Self-prescribed medication known to affect platelet function (e.g. aspirin and non-steroidal anti-inflammatory drugs) unless participant is willing to give up.
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- Bleeding disorders (e.g. haemophilia)
- Dietary supplements judged to affect study outcome
- Parallel participation in another research project which involves dietary intervention
- Blood donation within 16 weeks prior to the study
- Depressed or elevated blood pressure measurements (<90/50 or 95/50 if symptomatic or ≥ 160/100 mmHg)
- Any person related to or living with any member of the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.
Read the detailed description
Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in CVD risk. The mechanism by which this protective effect occurs is not clearly understood but research has focused on its potential to modulate platelet function. This single-blind, randomized, parallel design human intervention trial will recruit 99 participants to consume an orange flavoured beverage containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over a 5-day period. The study aims is to investigate the effects of consuming different doses of the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato pomace extracts was tested prior starting this study by undertaking a single ascending dose study.
- Conditions
- Cardiovascular Diseases
- Being tested
- Placebo control, Low dose pomace extract, High dose pomace extract
- Keywords
- Platelet Aggregation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo controlDietary supplement
The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions
Low dose pomace extractDietary supplement
Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
High dose pomace extractDietary supplement
Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | 100 g of flavoured water Receives: Dietary Supplement: Placebo control |
| Low dose pomace extract | Experimental | 1 g pomace extract powder Receives: Dietary Supplement: Low dose pomace extract |
| High dose pomace extract | Experimental | 2.5 g pomace extract powder Receives: Dietary Supplement: High dose pomace extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline platelet aggregation at three hours
Measured: Blood samples on two separate occasions (baseline and three hours post-intervention)
Secondary outcomes (1)
Change from baseline platelet aggregation at 5 days
Measured: Blood samples on two separate occasions (baseline and 5 days post- intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Estudios en Alimentos Procesados
- Sponsor type
- University, hospital or other
- Collaborators
- University of Talca, Quadram Institute Bioscience
- Responsible party
- Sponsor
- Investigators
- Ivan Palomo, Dr., Principal investigator, University of Talca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986165
- Sponsor's protocol ID
- R15F10012
- Acronym
- Tomasa
- Status last verified
- Aug 2018
- First submitted
- 23 Nov 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Law MR, Morris JK. By how much does fruit and vegetable consumption reduce the risk of ischaemic heart disease: response to commentary. Eur J Clin Nutr. 1999 Nov;53(11):903-4. doi: 10.1038/sj.ejcn.1600944.
PubMed 10557006Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.
PubMed 12411949Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
PubMed 18077812O'Kennedy N, Crosbie L, van Lieshout M, Broom JI, Webb DJ, Duttaroy AK. Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):570-9. doi: 10.1093/ajcn/84.3.570.
PubMed 16960171Fuentes E, Forero-Doria O, Carrasco G, Marican A, Santos LS, Alarcon M, Palomo I. Effect of tomato industrial processing on phenolic profile and antiplatelet activity. Molecules. 2013 Sep 17;18(9):11526-36. doi: 10.3390/molecules180911526.
PubMed 24048285Fuentes E, Pereira J, Alarcon M, Valenzuela C, Perez P, Astudillo L, Palomo I. Protective Mechanisms of S. lycopersicum Aqueous Fraction (Nucleosides and Flavonoids) on Platelet Activation and Thrombus Formation: In Vitro, Ex Vivo and In Vivo Studies. Evid Based Complement Alternat Med. 2013;2013:609714. doi: 10.1155/2013/609714. Epub 2013 Sep 16.
PubMed 24159349Rodriguez-Azua R, Treuer A, Moore-Carrasco R, Cortacans D, Gutierrez M, Astudillo L, Fuentes E, Palomo I. Effect of tomato industrial processing (different hybrids, paste, and pomace) on inhibition of platelet function in vitro, ex vivo, and in vivo. J Med Food. 2014 Apr;17(4):505-11. doi: 10.1089/jmf.2012.0243. Epub 2013 Dec 10.
PubMed 24325459
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
- ClinicalTrials.gov ID
- NCT02986165
- Acronym / sponsor ID
- Tomasa / R15F10012
- Conditions
- Cardiovascular Diseases
- Keywords
- Platelet Aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centro de Estudios en Alimentos ProcesadosUniversity, hospital or other
- Collaborators
- University of Talca, Quadram Institute Bioscience
- Study start
- Sep 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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 study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.
Detailed description
Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in CVD risk. The mechanism by which this protective effect occurs is not clearly understood but research has focused on its potential to modulate platelet function. This single-blind, randomized, parallel design human intervention trial will recruit 99 participants to consume an orange flavoured beverage containing different doses of a tomato pomace extract (1.0 and 2.5 g) or placebo control over a 5-day period. The study aims is to investigate the effects of consuming different doses of the tomato pomace extract on platelet aggregation. Safety and tolerability of the tomato pomace extracts was tested prior starting this study by undertaking a single ascending dose study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Dietary Supplement: Placebo control100 g of flavoured water |
| Low dose pomace extract | Experimental | Dietary Supplement: Low dose pomace extract1 g pomace extract powder |
| High dose pomace extract | Experimental | Dietary Supplement: High dose pomace extract2.5 g pomace extract powder |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Apparently healthy men aged between 18 and 26 years
- BMI >19.5 and <26.0
- Platelet aggregation response corresponding to ≥ 65%
Key exclusion criteria (12 listed)
- Known tomato allergy
- Chronic medical conditions requiring active treatment (e.g. cardiovascular disease, diabetes, asthma)
- Gastro-intestinal disease/disorders
- Smokers
- Medically prescribed medication known to affect platelet function
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 |
|---|---|---|
| Placebo controlThe placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions | Dietary supplement | Placebo control |
| Low dose pomace extractImmediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract. | Dietary supplement | Low dose pomace extract |
| High dose pomace extractImmediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract. | Dietary supplement | High dose pomace extract |
Primary outcome
Change from baseline platelet aggregation at three hours
Time frame: Blood samples on two separate occasions (baseline and three hours post-intervention)
1 secondary outcome
Change from baseline platelet aggregation at 5 days
Time frame: Blood samples on two separate occasions (baseline and 5 days post- intervention)
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 28 Aug 2018.
- Background: PubMed 10557006Law MR, Morris JK. By how much does fruit and vegetable consumption reduce the risk of ischaemic heart disease: response to commentary. Eur J Clin Nutr. 1999 Nov;53(11):903-4. doi: 10.1038/sj.ejcn.1600944.
- Background: PubMed 12411949Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.
- Background: PubMed 18077812Davi G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. doi: 10.1056/NEJMra071014. No abstract available.
- Background: PubMed 16960171O'Kennedy N, Crosbie L, van Lieshout M, Broom JI, Webb DJ, Duttaroy AK. Effects of antiplatelet components of tomato extract on platelet function in vitro and ex vivo: a time-course cannulation study in healthy humans. Am J Clin Nutr. 2006 Sep;84(3):570-9. doi: 10.1093/ajcn/84.3.570.
- Background: PubMed 24048285Fuentes E, Forero-Doria O, Carrasco G, Marican A, Santos LS, Alarcon M, Palomo I. Effect of tomato industrial processing on phenolic profile and antiplatelet activity. Molecules. 2013 Sep 17;18(9):11526-36. doi: 10.3390/molecules180911526.
- Background: PubMed 24159349Fuentes E, Pereira J, Alarcon M, Valenzuela C, Perez P, Astudillo L, Palomo I. Protective Mechanisms of S. lycopersicum Aqueous Fraction (Nucleosides and Flavonoids) on Platelet Activation and Thrombus Formation: In Vitro, Ex Vivo and In Vivo Studies. Evid Based Complement Alternat Med. 2013;2013:609714. doi: 10.1155/2013/609714. Epub 2013 Sep 16.
- Background: PubMed 24325459Rodriguez-Azua R, Treuer A, Moore-Carrasco R, Cortacans D, Gutierrez M, Astudillo L, Fuentes E, Palomo I. Effect of tomato industrial processing (different hybrids, paste, and pomace) on inhibition of platelet function in vitro, ex vivo, and in vivo. J Med Food. 2014 Apr;17(4):505-11. doi: 10.1089/jmf.2012.0243. Epub 2013 Dec 10.
- 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.
Ivan Palomo, Dr. principal investigator
University of Talca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose pomace extract and High dose pomace extract in people with Cardiovascular Diseases, run by Centro de Estudios en Alimentos Procesados at 1 site in Chile.
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 3 inclusion and 12 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 28 Aug 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Change from baseline platelet aggregation at three hours (time frame: Blood samples on two separate occasions (baseline and three hours post-intervention)). 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 NCT02986165, which also lists 7 linked publications.
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 28 Aug 2018.