RT Journal Article T1 Safety and Efficacy of a Beverage Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Lipid Status in Healthy Subjects: An Intervention Study (the Lupine-1 Trial). A1 Cruz-Chamorro, Ivan A1 Alvarez-Sanchez, Nuria A1 Alvarez-Rios, Ana Isabel A1 Santos-Sanchez, Guillermo A1 Pedroche, Justo A1 Millan, Francisco A1 Carrera Sanchez, Cecilio A1 Fernandez-Pachon, Maria Soledad A1 Millan-Linares, Maria Carmen A1 Martinez-Lopez, Alicia A1 Lardone, Patricia Judith A1 Bejarano, Ignacio A1 Guerrero, Juan Miguel A1 Carrillo-Vico, Antonio K1 cholesterol K1 hydrolysate K1 inflammation K1 lupine K1 oxidative stress AB We have previously demonstrated the anti-inflammatory and antioxidant properties of in vitro administered Lupinus angustifolius protein hydrolysates (LPHs) on human peripheral blood mononuclear cells (PBMCs). This study aims to evaluate the safety and efficacy of a beverage containing LPHs (LPHb) on the immune, oxidative and metabolic status of healthy subjects. In this open-label intervention, 33 participants daily ingest a LPHb containing 1 g LPHs for 28 days. Biochemical parameters are assayed in fasting peripheral blood and urine samples before, during (14 days) and after LPHb ingestion. Participants' health status and the immune and antioxidant responses of PBMCs are also evaluated throughout the trial. The LPHb ingestion is safe and effective in both increasing the anti-/pro-inflammatory response of PBMCs and improving the cellular anti-oxidant capacity. LPHb also reduces the low-density lipoprotein-cholesterol (LDL-C)/high-density lipoprotein-cholesterol (HDL-C) atherogenic index. LPHb effect is particularly beneficial on decreasing not only the LDL-C/HDL-C index but also serum total cholesterol levels in the male cohort that shows the highest baseline levels of well-known cardiovascular risk factors. This is the first study to show the pleiotropic actions of a lupine bioactive peptides-based functional food on key steps of atherosclerosis including inflammation, oxidative stress, and cholesterol metabolism. PB Wiley-VCH Verlag GmbH & Co. KGaA YR 2021 FD 2021-07-21 LK http://hdl.handle.net/10668/17809 UL http://hdl.handle.net/10668/17809 LA en NO Cruz-Chamorro I, Álvarez-Sánchez N, Álvarez-Ríos AI, Santos-Sánchez G, Pedroche J, Millán F, et al. Safety and Efficacy of a Beverage Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Lipid Status in Healthy Subjects: An Intervention Study (the Lupine-1 Trial). Mol Nutr Food Res. 2021 Jul;65(14):e2100139. NO This work was supported by the Spanish Government, Ministerio de Economía y Competitividad [AGL2012-40247-C02-01 and AGL2012-40247-C02-02], the Andalusian Government Ministry of Health [PC-0111-2016-0111] and the PAIDI Program from the Andalusian Government [CTS160]. IC-C and GS-S were supported by FPU grants from the Spanish Ministerio de Educación, Cultura y Deporte, [FPU13/01210 and FPU16/02339, respectively]. NA-S was supported by fellowships from the National Net RETICEF for Aging Studies [Red Temática de Investigación Cooperativa en Envejecimiento y Fragilidad; RD06/0013/0001 and RD12/0043/0012; from the Instituto de Salud Carlos III, Spanish Ministerio de Ciencia e Innovación]. AML was supported by a PIF grant from the V Program of Inner Initiative for Research and Transfer of University of Seville [V PPIT-US]. I-B was granted by the VI Program of Inner Initiative for Research and Transfer of University of Seville [VI PPIT-US]. The authors thank John Leslie Brown for editing the manuscript. DS RISalud RD Apr 8, 2025