Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

Centro de Estudios en Alimentos Procesados99 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Diseases

Interventions

Placebo controlDIETARY_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 extractDIETARY_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 extractDIETARY_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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Talca

Talca, Maule Region, Chile

Outcomes

Primary Outcomes

Change from baseline platelet aggregation at three hours

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

Secondary Outcomes

Change from baseline platelet aggregation at 5 days

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

Data from ClinicalTrials.gov

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