Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation
NCT ID: NCT02986165
Last Updated: 2018-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2016-09-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Placebo control
100 g of flavoured water
Placebo control
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 extract
1 g pomace extract powder
Low dose pomace extract
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 extract
2.5 g pomace extract powder
High dose pomace extract
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.
Interventions
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Placebo control
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 extract
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 extract
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.
Eligibility Criteria
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Inclusion Criteria
* BMI \>19.5 and \<26.0
* Platelet aggregation response corresponding to ≥ 65%
Exclusion Criteria
* 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.
* 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
18 Years
26 Years
MALE
Yes
Sponsors
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University of Talca
OTHER
Quadram Institute Bioscience
OTHER
Centro de Estudios en Alimentos Procesados
OTHER
Responsible Party
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Principal Investigators
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Ivan Palomo, Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Talca
Locations
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University of Talca
Talca, Maule Region, Chile
Countries
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References
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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.
Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.
Davi 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.
O'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.
Fuentes 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.
Fuentes 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.
Rodriguez-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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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R15F10012
Identifier Type: -
Identifier Source: org_study_id
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