Reule Claudia A, Goyvaerts Birgit, Schoen Christiane
Nutritional CRO, BioTeSys GmbH, Schelztorstraße 54-56, 73728, Esslingen, Germany.
Dr. Loges & Co. GmbH, Schützenstraße 5, 21423, Winsen, Luhe, Germany.
BMC Complement Altern Med. 2017 Feb 2;17(1):92. doi: 10.1186/s12906-017-1603-9.
Nutrition plays an important role in prevention and management of cardiovascular diseases (CVD) in early stages. Recent research demonstrated beneficial effects of various nutritional ingredients on vascular health. The aim of the current study was to evaluate the effects of an L-arginine-based multi ingredient product (AbMIP) on vascular function.
Twenty-five male and female subjects, aged between 45 and 65 years with elevated blood pressure and hyperhomocysteinemia were included in this cross-over trial. Subjects were randomly assigned to one of the two sequence groups (AbMIP -placebo or placebo - AbMIP). AbMIP and placebo were taken for 4 weeks, each. Endothelial function under fasting conditions, blood pressure, postprandial endothelial function after consumption of a high fat meal, homocysteine, asymmetric dimethyl arginine (ADMA) and Hba1c were determined.
AbMIP significantly improved fasting endothelial function determined by EndoPAT™ when compared to placebo (p = 0.047). Similarly, homocysteine levels were significantly decreased after verum supplementation when compared to placebo (p < 0.0001). Systolic blood pressure decreased significantly under AbMIP (p = 0.002) and the reduction was more pronounced when compared to placebo. However, due to placebo-effects no significant difference could be found between groups (p = 0.586). The effects on postprandial endothelial function were stronger for AbMIP when compared with placebo but did not reach significance (p = 0.201). No significant effects of AbMIP were observed regarding HbA1c, ADMA and diastolic blood pressure.
Due to improvement on endothelial function, decrease of elevated homocysteine levels and excellent tolerability, AbMIP was demonstrated to be a beneficial option for dietary treatment of endothelial dysfunction and hyperhomocysteinemia in early stages of CVD.
The clinical trials.gov identifier is NCT02392767 , November 14, 2014.
营养在心血管疾病(CVD)早期的预防和管理中起着重要作用。最近的研究表明各种营养成分对血管健康有益。本研究的目的是评估一种基于L-精氨酸的多成分产品(AbMIP)对血管功能的影响。
本交叉试验纳入了25名年龄在45至65岁之间、血压升高且患有高同型半胱氨酸血症的男性和女性受试者。受试者被随机分配到两个序列组之一(AbMIP-安慰剂组或安慰剂-AbMIP组)。AbMIP和安慰剂各服用4周。测定空腹条件下的内皮功能、血压、高脂餐后的餐后内皮功能、同型半胱氨酸、不对称二甲基精氨酸(ADMA)和糖化血红蛋白(HbA1c)。
与安慰剂相比,AbMIP显著改善了通过EndoPAT™测定的空腹内皮功能(p = 0.047)。同样,与安慰剂相比,服用真药后同型半胱氨酸水平显著降低(p < 0.0001)。在AbMIP治疗下收缩压显著降低(p = 0.002),与安慰剂相比降低更为明显。然而,由于安慰剂效应,两组之间未发现显著差异(p = 0.586)。与安慰剂相比,AbMIP对餐后内皮功能的影响更强,但未达到显著水平(p = 0.201)。未观察到AbMIP对HbA1c、ADMA和舒张压有显著影响。
由于对内皮功能的改善、升高的同型半胱氨酸水平的降低以及良好的耐受性,AbMIP被证明是CVD早期内皮功能障碍和高同型半胱氨酸血症饮食治疗的有益选择。
临床试验.gov标识符为NCT02392767,2014年11月14日。