Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

Cardiovascular Diseases Clinical Trial

— Tomasa  

Official title:

Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986165
• Other study ID #: R15F10012
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Centro de Estudios en Alimentos Procesados
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Chile	University of Talca	Talca	Maule

Sponsors (3)

Lead Sponsor	Collaborator
Centro de Estudios en Alimentos Procesados	Quadram Institute, University of Talca

Country where clinical trial is conducted

Chile, 

References & Publications (7)

Davì G, Patrono C. Platelet activation and atherothrombosis. N Engl J Med. 2007 Dec 13;357(24):2482-94. Review. — View Citation

Fuentes E, Forero-Doria O, Carrasco G, Maricán A, Santos LS, Alarcón 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. — View Citation

Fuentes E, Pereira J, Alarcón M, Valenzuela C, Pérez 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. — View Citation

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. — View 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. — View Citation

Rodríguez-Azúa R, Treuer A, Moore-Carrasco R, Cortacáns D, Gutiérrez 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. — View Citation

Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline platelet aggregation at three hours		Blood samples on two separate occasions (baseline and three hours post-intervention)
Secondary	Change from baseline platelet aggregation at 5 days		Blood samples on two separate occasions (baseline and 5 days post- intervention)