Abstract
Consumption of tomato and tomato-based products is associated with risk reduction of cardiovascular disease (CVD). Protective effect of tomato is not clearly understood, but there is an interest in its ability to affect platelet aggregation (coagulation). Therefore, the aim of the present study is to describe the protocol of a single blind, parallel design (3-groups), placebo controlled trial, which will assess acute and “acute upon 5-day repeated dose” effects of ingesting a tomato pomace extract on platelet aggregation. Participants will be randomized to receive a flavoured water either with 1 g tomato pomace extract, 2.5 g tomato pomace extract or placebo negative control. A total of 99 people are required to complete (n = 33/group). Each group will ingest either a treatment or placebo once daily, for 5-days and blood samples will be taken to analyze platelet aggregation. For 14-days preceding the baseline assessment day and for the 5-day period of intervention, participants will have to exclude some foods/beverages from their diet, which are known to affect platelet function. The present study is expected to generate significant information about the effect of tomato pomace extract consumption on platelet function of volunteers.
Highlights
Subject Area: More specific subject area: Protocol name: Reagents/tools: *Experimental design: Trial registration: Ethics: Pharmacology, Toxicology and Pharmaceutical Science Nutrition
Clinicaltrials.gov (Ref: NCT02986165) The trial will be conducted in the research facility at the University of Talca and Centro de Estudios en Alimentos Procesados (CEAP), all procedures will be approved by the University of Talca Research Ethics Committee
Evidence from human intervention trials and mechanistic studies suggests that tomato and tomato based products are associated with a reduction in cardiovascular disease (CVD) risk [1,2,3,4]
Summary
Subject Area: More specific subject area: Protocol name: Reagents/tools: *Experimental design: Trial registration: Ethics: Pharmacology, Toxicology and Pharmaceutical Science Nutrition. In a single-blind, randomized, parallel design human intervention trial (3groups), we aim to recruit 99 participants (33/group) to ingest an orange flavoured beverage containing different doses of a tomato pomace extract (1 and 2.5 g,) or placebo control over a 5-day period. The acute and “acute upon 5-day repeated dose” effects of the treatments on platelet aggregation will be evaluated at the start and end of the intervention period. Before implementing this large scale human intervention trial we will conduct a preliminary ‘ascending dose human tolerance study’ in a small group of participants across a~3 week period. Ingestion of a tomato pomace extract for 5 days will significantly reduce platelet aggregation in humans compared with a placebo control and in a dose dependent manner
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