Evaluation of the equivalence of different intakes of Fruitflow in affecting platelet aggregation and thrombin generation capacity in a randomized, double-blinded pilot study in male subjects

Ranjit K Das,Ruedi Duss,Dipankar Biswas,Niamh O’Kennedy,Asim K Duttaroy,Tanushree Datta

doi:10.1186/s40795-021-00485-5

Ranjit K Das, Ruedi Duss + Show 4 more

Open Access

https://doi.org/10.1186/s40795-021-00485-5

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Abstract

BackgroundThe water-soluble tomato extract, Fruitflow® is a dietary antiplatelet which can be used to lower platelet aggregability in primary preventative settings. We carried out a pilot study to investigate the range of intakes linked to efficacy and to make an initial assessment of variability in response to Fruitflow®.MethodsPlatelet response to adenosine diphosphate (ADP) agonist and thrombin generation capacity were monitored at baseline and 24 h after consuming 0, 30, 75, 150 or 300 mg of Fruitflow® in a randomized, double-blinded crossover study in male subjects 30–65 years of age (N = 12). Results were evaluated for equivalence to the standard 150 mg dose.ResultsResults showed that the changes from baseline aggregation and thrombin generation observed after the 75 mg, 150 mg, and 300 mg supplements were equivalent. Aggregation was reduced from baseline by − 12.9 ± 17.7%, − 12.0 ± 13.9% and − 17.7 ± 15.7% respectively, while thrombin generation capacity fell by − 8.6 ± 4.1%, − 9.2 ± 3.1% and − 11.3 ± 2.3% respectively. Effects observed for 0 mg and 30 mg supplements were non-equivalent to 150 mg and not different from baseline (aggregation changed by 3.0 ± 5.0% and − 0.7 ± 10.2% respectively, while thrombin generation changed by 0.8 ± 3.0% and 0.8 ± 3.1% respectively).ConclusionsThe data suggest that the efficacious range for Fruitflow® lies between 75 mg and 300 mg, depending on the individual. It may be pertinent to personalize the daily intake of Fruitflow® depending on individual platelet response.Trial registrationISRCTN53447583, 24/02/2021.

Highlights

Platelets play a key role in blood homeostasis; their responsiveness to a diverse range of external stimuli allows them to respond to vascular stress and helps to preserve the integrity of the vascular system
The two treatments, which are non-equivalent to FF150 (Con and FF30), are more similar to each other when considering Thrombin generation capacity (TGC) compared to when considering aggregation response, suggesting that there may be a specific reason behind the rise in platelet aggregation observed after intervention with FF30. Our aims in this pilot study were to examine whether consuming amounts of Fruitflow® less than 150 mg could result in desirable levels of platelet suppression ex vivo, and to assess the platelet response variability to all doses tested
No two individuals’ platelets are precisely the same, something that can be clearly observed in the heterogeneity of their responses to agonist and to antiplatelet agents [30,31,32,33,34], Studies using antiplatelet drugs have shown that marked differences in platelet responses may be linked to such factors, with genomic and nutrigenomic reasons postulated [35, 36]

Summary

Introduction

Platelets play a key role in blood homeostasis; their responsiveness to a diverse range of external stimuli allows them to respond to vascular stress and helps to preserve the integrity of the vascular system. This sensitivity can result in a hyperaggregable. Platelet influence on the development and progression of cardiovascular disease (CVD) is well established, especially in atherosclerosis and acute thrombotic events. Nutritional / botanical approaches to lowering platelet hyperactivity are attractive, as quite a range of plant-derived antiplatelets exist, the amount of data available for most remains relatively low as yet [8,9,10]. We carried out a pilot study to investigate the range of intakes linked to efficacy and to make an initial assessment of variability in response to Fruitflow®

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Conclusion