Effect of Ingesting a Tomato Pomace Extract on Platelet Aggregation

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

Detailed Description
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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.

Official Title
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Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Placebo control
* Dietary Supplement: Low dose pomace extract
* Dietary Supplement: High dose pomace extract


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo control<br>100 g of flavoured water | Dietary Supplement: Placebo control<br>* The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions<br>|
| Experimental: Low dose pomace extract<br>1 g pomace extract powder | Dietary Supplement: Low dose pomace extract<br>* 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.<br>|
| Experimental: High dose pomace extract<br>2.5 g pomace extract powder | Dietary Supplement: High dose pomace extract<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Aggregation