Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects
A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy vo...
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description | A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy volunteers. Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people. |
doi_str_mv | 10.3390/nu12051475 |
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Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people.</description><identifier>ISSN: 2072-6643</identifier><identifier>EISSN: 2072-6643</identifier><identifier>DOI: 10.3390/nu12051475</identifier><identifier>PMID: 32438719</identifier><language>eng</language><publisher>Switzerland: MDPI AG</publisher><subject>Adult ; Anthropometry ; Antioxidants ; Biomarkers ; Blood & organ donations ; Blood pressure ; Blood Pressure - drug effects ; Carbonyl compounds ; Carbonyls ; Cardiovascular disease ; Cardiovascular diseases ; Cardiovascular Diseases - prevention & control ; Cholesterol ; Citrus - chemistry ; Citrus fruits ; Citrus paradisi ; Diabetes ; Diet ; Dietary Supplements ; Disease prevention ; Double-Blind Method ; Double-blind studies ; Drug dosages ; Endothelium, Vascular - drug effects ; Exercise ; Female ; Flavanones - administration & dosage ; Flavones ; Flavones - administration & dosage ; Flavonoids ; Grapefruit ; Health care ; Health risks ; Healthy Volunteers ; Heart Disease Risk Factors ; Homeostasis ; Humans ; Inflammation Mediators - blood ; Interleukin 6 ; Lipids ; Lipids - blood ; Male ; Middle Aged ; Mortality ; Nutrition research ; Olea - chemistry ; Oranges ; Oxidative stress ; Oxidative Stress - drug effects ; Physical activity ; Plant extracts ; Polyphenols ; Polyphenols - administration & dosage ; Product development ; Quality of Life ; Randomization ; Risk ; Statistical analysis ; Vasodilation ; Vasodilation - drug effects ; Womens health</subject><ispartof>Nutrients, 2020-05, Vol.12 (5), p.1475</ispartof><rights>2020. This work is licensed under http://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2020 by the authors. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c472t-df67cf538b07252b629310b83835ab3de2dd60c7c11ec1fc4d6ab3ef292980fa3</citedby><cites>FETCH-LOGICAL-c472t-df67cf538b07252b629310b83835ab3de2dd60c7c11ec1fc4d6ab3ef292980fa3</cites><orcidid>0000-0002-2841-5502 ; 0000-0003-3968-9477 ; 0000-0001-7589-1344 ; 0000-0002-8837-1927 ; 0000-0002-1021-5385</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284884/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284884/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32438719$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sánchez Macarro, Maravillas</creatorcontrib><creatorcontrib>Martínez Rodríguez, Juan Pablo</creatorcontrib><creatorcontrib>Bernal Morell, Enrique</creatorcontrib><creatorcontrib>Pérez-Piñero, Silvia</creatorcontrib><creatorcontrib>Victoria-Montesinos, Desirée</creatorcontrib><creatorcontrib>García-Muñoz, Ana María</creatorcontrib><creatorcontrib>Cánovas García, Fernando</creatorcontrib><creatorcontrib>Castillo Sánchez, Julián</creatorcontrib><creatorcontrib>López-Román, Francisco Javier</creatorcontrib><title>Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects</title><title>Nutrients</title><addtitle>Nutrients</addtitle><description>A single-center, randomized, double-blind controlled trial was conducted to assess the efficacy of a food supplement based on a combination of grapefruit, bitter orange, and olive extracts administered for eight weeks (n = 51) versus placebo (n = 45) on reduction of cardiovascular risk in healthy volunteers. Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. All these findings, taken together, support a beneficial effect of supplementation with a mixture of grapefruit, bitter orange fruits, and olive leaf extracts on underlying mechanisms that may interact each other to decrease the cardiovascular risk in healthy people.</description><subject>Adult</subject><subject>Anthropometry</subject><subject>Antioxidants</subject><subject>Biomarkers</subject><subject>Blood & organ donations</subject><subject>Blood pressure</subject><subject>Blood Pressure - drug effects</subject><subject>Carbonyl compounds</subject><subject>Carbonyls</subject><subject>Cardiovascular disease</subject><subject>Cardiovascular diseases</subject><subject>Cardiovascular Diseases - prevention & control</subject><subject>Cholesterol</subject><subject>Citrus - chemistry</subject><subject>Citrus fruits</subject><subject>Citrus paradisi</subject><subject>Diabetes</subject><subject>Diet</subject><subject>Dietary Supplements</subject><subject>Disease prevention</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Drug dosages</subject><subject>Endothelium, Vascular - 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Study variables included flow-mediated vasodilation (FMD), blood pressure (BP), lipid profile, thrombotic status, oxidative stress biomarkers, inflammation-related biomarkers, anthropometric variables, quality of life, and physical activity. The per-protocol data set was analyzed. In the active product group, there were statistically significant within-group differences at eight weeks as compared with baseline in FMD, systolic and diastolic BP, total cholesterol, LDL-C, LDL-oxidase, oxidized/reduced glutathione ratio, protein carbonyl, and IL-6. Significant between-group differences in these variables were also found. Significant changes in anthropometric variables and quality of life were not observed in the study groups. Changes in the level of physical activity were not recorded. Treatment with the active product was well tolerated. 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subjects | Adult Anthropometry Antioxidants Biomarkers Blood & organ donations Blood pressure Blood Pressure - drug effects Carbonyl compounds Carbonyls Cardiovascular disease Cardiovascular diseases Cardiovascular Diseases - prevention & control Cholesterol Citrus - chemistry Citrus fruits Citrus paradisi Diabetes Diet Dietary Supplements Disease prevention Double-Blind Method Double-blind studies Drug dosages Endothelium, Vascular - drug effects Exercise Female Flavanones - administration & dosage Flavones Flavones - administration & dosage Flavonoids Grapefruit Health care Health risks Healthy Volunteers Heart Disease Risk Factors Homeostasis Humans Inflammation Mediators - blood Interleukin 6 Lipids Lipids - blood Male Middle Aged Mortality Nutrition research Olea - chemistry Oranges Oxidative stress Oxidative Stress - drug effects Physical activity Plant extracts Polyphenols Polyphenols - administration & dosage Product development Quality of Life Randomization Risk Statistical analysis Vasodilation Vasodilation - drug effects Womens health |
title | Effect of a Combination of Citrus Flavones and Flavanones and Olive Polyphenols for the Reduction of Cardiovascular Disease Risk: An Exploratory Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects |
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