University of Talca
Talca, Maule Region, 3460000, Chile
NCT Number: NCT02986165
This study evaluates the acute and longer term effects of a tomato pomace extract on platelet aggregation in health subjects.
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Notify Me18 year–26 year
Male
Interventional
Not applicable
Talca, Maule Region, 3460000, Chile
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions
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.
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.
Time frame: Blood samples on two separate occasions (baseline and three hours post-intervention)
Time frame: Blood samples on two separate occasions (baseline and 5 days post- intervention)
Centro de Estudios en Alimentos Procesados
Other
Efficacy of a Tomato Pomace Extract for Inhibiting Platelet Aggregation
Acronym: Tomasa
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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