Cargando…

Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers

Bioactive supplements display relevant therapeutic properties when properly applied according to validated molecular effects. Our previous research efforts established the basis to develop a dietary supplement based on a Rosmarinus officinalis supercritical extract. This was enriched in phenolic dit...

Descripción completa

Detalles Bibliográficos
Autores principales: Gómez de Cedrón, Marta, Laparra, José Moises, Loria-Kohen, Viviana, Molina, Susana, Moreno-Rubio, Juan, Montoya, Juan Jose, Torres, Carlos, Casado, Enrique, Reglero, Guillermo, Ramírez de Molina, Ana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6769991/
https://www.ncbi.nlm.nih.gov/pubmed/31450563
http://dx.doi.org/10.3390/nu11092001
_version_ 1783455366742278144
author Gómez de Cedrón, Marta
Laparra, José Moises
Loria-Kohen, Viviana
Molina, Susana
Moreno-Rubio, Juan
Montoya, Juan Jose
Torres, Carlos
Casado, Enrique
Reglero, Guillermo
Ramírez de Molina, Ana
author_facet Gómez de Cedrón, Marta
Laparra, José Moises
Loria-Kohen, Viviana
Molina, Susana
Moreno-Rubio, Juan
Montoya, Juan Jose
Torres, Carlos
Casado, Enrique
Reglero, Guillermo
Ramírez de Molina, Ana
author_sort Gómez de Cedrón, Marta
collection PubMed
description Bioactive supplements display relevant therapeutic properties when properly applied according to validated molecular effects. Our previous research efforts established the basis to develop a dietary supplement based on a Rosmarinus officinalis supercritical extract. This was enriched in phenolic diterpenes (RE) with proven properties against signaling pathways involved in colon tumorigenesis, and shark liver oil rich in alkylglycerols (AKG) as a bioactive lipid vehicle to improve RE bioavailability and synergize with the potential therapeutic action of the extract. Herein, we have investigated the tolerability and safety of the supplement and the biological and molecular effects from an immuno-nutritional perspective. Sixty healthy volunteers participated in a six week, double-blind, randomized parallel pilot study with two study arms: RE-AKG capsules (CR) and control capsules (CC). Mean age (±SD) of volunteers was 28.32 (±11.39) and 27.5 (±9.04) for the control and the study groups, respectively. Safety of the CR product consumption was confirmed by analyzing liver profile, vital constants, and oxidation markers (LDLox in blood and isoprostanes and thromboxanes in urine). The following were monitored: (1) the phenotyping of plasmatic leukocytes and the ex vivo response of lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs); (2) expression of genes associated with immune-modulation, inflammation, oxidative stress, lipid metabolism, and tumorigenesis; and (3) the correlation of selected genetic variants (SNPs) with the differential responses among individuals. The lack of adverse effects on liver profile and oxidation markers, together with adequate tolerability and safe immunological adaptations, provide high-quality information for the potential use of CR as co-adjuvant of therapeutic strategies against colorectal cancer.
format Online
Article
Text
id pubmed-6769991
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-67699912019-10-30 Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers Gómez de Cedrón, Marta Laparra, José Moises Loria-Kohen, Viviana Molina, Susana Moreno-Rubio, Juan Montoya, Juan Jose Torres, Carlos Casado, Enrique Reglero, Guillermo Ramírez de Molina, Ana Nutrients Article Bioactive supplements display relevant therapeutic properties when properly applied according to validated molecular effects. Our previous research efforts established the basis to develop a dietary supplement based on a Rosmarinus officinalis supercritical extract. This was enriched in phenolic diterpenes (RE) with proven properties against signaling pathways involved in colon tumorigenesis, and shark liver oil rich in alkylglycerols (AKG) as a bioactive lipid vehicle to improve RE bioavailability and synergize with the potential therapeutic action of the extract. Herein, we have investigated the tolerability and safety of the supplement and the biological and molecular effects from an immuno-nutritional perspective. Sixty healthy volunteers participated in a six week, double-blind, randomized parallel pilot study with two study arms: RE-AKG capsules (CR) and control capsules (CC). Mean age (±SD) of volunteers was 28.32 (±11.39) and 27.5 (±9.04) for the control and the study groups, respectively. Safety of the CR product consumption was confirmed by analyzing liver profile, vital constants, and oxidation markers (LDLox in blood and isoprostanes and thromboxanes in urine). The following were monitored: (1) the phenotyping of plasmatic leukocytes and the ex vivo response of lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells (PBMCs); (2) expression of genes associated with immune-modulation, inflammation, oxidative stress, lipid metabolism, and tumorigenesis; and (3) the correlation of selected genetic variants (SNPs) with the differential responses among individuals. The lack of adverse effects on liver profile and oxidation markers, together with adequate tolerability and safe immunological adaptations, provide high-quality information for the potential use of CR as co-adjuvant of therapeutic strategies against colorectal cancer. MDPI 2019-08-24 /pmc/articles/PMC6769991/ /pubmed/31450563 http://dx.doi.org/10.3390/nu11092001 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Gómez de Cedrón, Marta
Laparra, José Moises
Loria-Kohen, Viviana
Molina, Susana
Moreno-Rubio, Juan
Montoya, Juan Jose
Torres, Carlos
Casado, Enrique
Reglero, Guillermo
Ramírez de Molina, Ana
Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title_full Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title_fullStr Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title_full_unstemmed Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title_short Tolerability and Safety of a Nutritional Supplement with Potential as Adjuvant in Colorectal Cancer Therapy: A Randomized Trial in Healthy Volunteers
title_sort tolerability and safety of a nutritional supplement with potential as adjuvant in colorectal cancer therapy: a randomized trial in healthy volunteers
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6769991/
https://www.ncbi.nlm.nih.gov/pubmed/31450563
http://dx.doi.org/10.3390/nu11092001
work_keys_str_mv AT gomezdecedronmarta tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT laparrajosemoises tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT loriakohenviviana tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT molinasusana tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT morenorubiojuan tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT montoyajuanjose tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT torrescarlos tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT casadoenrique tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT regleroguillermo tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers
AT ramirezdemolinaana tolerabilityandsafetyofanutritionalsupplementwithpotentialasadjuvantincolorectalcancertherapyarandomizedtrialinhealthyvolunteers