Placebo Negative Control Research Articles

Antiplatelet protocol: Effects of ingesting a tomato pomace extract on human platelet aggregation

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.