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

Centro de Estudios en Alimentos Procesados

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Placebo control; Dietary Supplement: High dose pomace extract; Dietary Supplement: Low dose pomace extract

Study type: Interventional

Funder types: Other

Identifiers

NCT02986165

R15F10012

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: Male

Ages: 18 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups, including a placebo group

Placebo control

Placebo Comparator group

Description:

100 g of flavoured water

Treatment:

Dietary Supplement: Placebo control

Low dose pomace extract

Experimental group

Description:

1 g pomace extract powder

Treatment:

Dietary Supplement: Low dose pomace extract

High dose pomace extract

Experimental group

Description:

2.5 g pomace extract powder

Treatment:

Dietary Supplement: High dose pomace extract