Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation (Tomasa)

August 24, 2018 updated by: Centro de Estudios en Alimentos Procesados

Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Maule
      • Talca, Maule, Chile, 3460000
        • University of Talca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo control
100 g of flavoured water
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
Experimental: Low dose pomace extract
1 g pomace extract powder
Dietary supplement: 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.
Experimental: High dose pomace extract
2.5 g pomace extract powder
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline platelet aggregation at three hours
Time Frame: Blood samples on two separate occasions (baseline and three hours post-intervention)
Blood samples on two separate occasions (baseline and three hours post-intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline platelet aggregation at 5 days
Time Frame: Blood samples on two separate occasions (baseline and 5 days post- intervention)
Blood samples on two separate occasions (baseline and 5 days post- intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Estudios en Alimentos Procesados

Collaborators

Quadram Institute Bioscience
University of Talca

Investigators

  • Principal Investigator: Ivan Palomo, Dr., University of Talca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15F10012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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