Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

Not Applicable

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Dietary Supplement: Placebo control; Dietary Supplement: High dose pomace extract; Dietary Supplement: Low dose pomace extract

• Registration Number: NCT02986165
• Lead Sponsor: Centro de Estudios en Alimentos Procesados

Brief Summary

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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo control	Placebo control	100 g of flavoured water
High dose pomace extract	High dose pomace extract	2.5 g pomace extract powder
Low dose pomace extract	Low dose pomace extract	1 g pomace extract powder

Primary Outcome Measures

Name	Time	Method
Change from baseline platelet aggregation at three hours	Blood samples on two separate occasions (baseline and three hours post-intervention)

Secondary Outcome Measures

Name	Time	Method
Change from baseline platelet aggregation at 5 days	Blood samples on two separate occasions (baseline and 5 days post- intervention)

Trial Locations

Locations (1)

University of Talca; 🇨🇱 Talca, Maule, Chile