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在一项针对男性受试者的随机双盲试点研究中,评估不同摄入量的Fruitflow对血小板聚集和凝血酶生成能力影响的等效性。

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.

作者信息

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

机构信息

Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.

DSM Nutritional Products Ltd, 4002, Basel, Switzerland.

出版信息

BMC Nutr. 2021 Dec 6;7(1):80. doi: 10.1186/s40795-021-00485-5.

DOI:10.1186/s40795-021-00485-5
PMID:34865648
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8647412/
Abstract

BACKGROUND

The 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®.

METHODS

Platelet 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.

RESULTS

Results 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).

CONCLUSIONS

The 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 REGISTRATION

ISRCTN53447583 , 24/02/2021.

摘要

背景

水溶性番茄提取物Fruitflow®是一种膳食抗血小板剂,可用于在一级预防中降低血小板聚集性。我们开展了一项初步研究,以调查与疗效相关的摄入量范围,并对Fruitflow®反应的变异性进行初步评估。

方法

在一项针对30至65岁男性受试者(N = 12)的随机、双盲交叉研究中,在基线以及摄入0、30、75、150或300毫克Fruitflow® 24小时后,监测血小板对二磷酸腺苷(ADP)激动剂的反应以及凝血酶生成能力。对结果进行评估,以确定其与标准150毫克剂量是否等效。

结果

结果显示,75毫克、150毫克和300毫克补充剂后观察到的与基线聚集和凝血酶生成的变化是等效的。聚集分别较基线降低了-12.9±17.7%、-12.0±13.9%和-17.7±15.7%,而凝血酶生成能力分别下降了-8.6±4.1%、-9.2±3.1%和-11.3±2.3%。0毫克和30毫克补充剂观察到的效果与150毫克不等效,且与基线无差异(聚集分别变化了3.0±5.0%和-0.7±10.2%,而凝血酶生成分别变化了0.8±3.0%和0.8±3.1%)。

结论

数据表明,Fruitflow®的有效范围在75毫克至300毫克之间,具体取决于个体。根据个体血小板反应个性化确定Fruitflow®的每日摄入量可能是恰当的。

试验注册

ISRCTN53447583,2021年2月24日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2100/8647412/b510d1144f4c/40795_2021_485_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2100/8647412/a3cf5d286f30/40795_2021_485_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2100/8647412/b510d1144f4c/40795_2021_485_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2100/8647412/a3cf5d286f30/40795_2021_485_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2100/8647412/b510d1144f4c/40795_2021_485_Fig2_HTML.jpg

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