Clinical trial NCT02986165: Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation
Official title: Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Platelet Aggregation
Lead sponsor: Centro de Estudios en Alimentos Procesados
Sponsor class: OTHER
Collaborators: name: University of Talca
name: Quadram Institute Bioscience
First posted: 2016-12-08
Enrollment: 99
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy men aged between 18 and 26 years
* BMI \>19.5 and \<26.0
* Platelet aggregation response corresponding to ≥ 65%

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change from baseline platelet aggregation at three hours
timeFrame: Blood samples on two separate occasions (baseline and three hours post-intervention)
Secondary outcomes:
measure: Change from baseline platelet aggregation at 5 days
timeFrame: Blood samples on two separate occasions (baseline and 5 days post- intervention)
Other outcomes:
Locations:
city: Talca
country: Chile
facility: University of Talca
state: Maule
Study officials:
affiliation: University of Talca
name: Ivan Palomo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.