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Completed

NCT Number: NCT02986165

Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

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

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Key information

Age range

18 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Talca

Talca, Maule Region, 3460000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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.

Primary outcomes

  1. Change from baseline platelet aggregation at three hours

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

Secondary outcomes

  1. Change from baseline platelet aggregation at 5 days

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

Sponsors and collaborators

Lead sponsor

Centro de Estudios en Alimentos Procesados

Other

Collaborators

  • Quadram Institute Bioscience
  • University of Talca

Registry information

Official study title

Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation

Acronym: Tomasa

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 8, 2016
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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