Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

NCT02986165 | Completed

• 1 other identifier: R15F10012
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiovascular Diseases

Keywords

Platelet Aggregation

Outcome Measures

Primary Outcomes (1)

• Change from baseline platelet aggregation at three hours

  Blood samples on two separate occasions (baseline and three hours post-intervention)

Secondary Outcomes (1)

• Change from baseline platelet aggregation at 5 days

  Blood samples on two separate occasions (baseline and 5 days post- intervention)

Study Arms (3)

Placebo control

PLACEBO COMPARATOR

100 g of flavoured water

Dietary Supplement: Placebo control

Low dose pomace extract

EXPERIMENTAL

1 g pomace extract powder

Dietary Supplement: Low dose pomace extract

High dose pomace extract

EXPERIMENTAL

2.5 g pomace extract powder

Dietary Supplement: High dose pomace extract

Interventions

Placebo control DIETARY_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

Placebo control

Low dose pomace extract DIETARY_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.

Low dose pomace extract

High dose pomace extract DIETARY_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.

High dose pomace extract

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro de Estudios en Alimentos Procesados: lead
• University of Talca: collaborator
• Quadram Institute Bioscience: collaborator

Study Sites (1)

University of Talca

Talca, Maule Region, 3460000, Chile

Location

Related Publications (7)

• 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.

  PMID: 10557006 BACKGROUND

• Ruggeri ZM. Platelets in atherothrombosis. Nat Med. 2002 Nov;8(11):1227-34. doi: 10.1038/nm1102-1227. No abstract available.

  PMID: 12411949 BACKGROUND

• 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.

  PMID: 18077812 BACKGROUND

• 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.

  PMID: 16960171 BACKGROUND

• 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.

  PMID: 24048285 BACKGROUND

• 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.

  PMID: 24159349 BACKGROUND

• 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.

  PMID: 24325459 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Ivan Palomo, Dr.

  University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: December 8, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)