Effects of an L-arginine-based multi ingredient product on endothelial function in subjects with mild to moderate hypertension and hyperhomocysteinemia - a randomized, double-blind, placebo-controlled, cross-over trial.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
The clinical trials.gov identifier is NCT02392767 , November 14, 2014.
Nutritional CRO, BioTeSys GmbH, Schelztorstraße 54-56, 73728, Esslingen, Germany. c.reule@biotesys.de.
Claudia A
CA
Reule
Dr. Loges & Co. GmbH, Schützenstraße 5, 21423, Winsen, Luhe, Germany.
Birgit
B
Goyvaerts
Nutritional CRO, BioTeSys GmbH, Schelztorstraße 54-56, 73728, Esslingen, Germany.
Christiane
C
Schoen
D000368:Aged; D001120:Arginine / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D018592:Cross-Over Studies; D004338:Drug Combinations; D004730:Endothelium, Vascular / Q000187:drug effects; D005260:Female; D006801:Humans; D020138:Hyperhomocysteinemia / Q000188:drug therapy*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged
D004338:Drug Combinations; D001120:Arginine
Endothelial function; Folic acid; Hyperhomocysteinemia; Hypertension; L-arginine; Pycnogenol®