Biological Availability Clinical Trial
Official title:
Bioavailability of Hydroxytyrosol From Two Olive Watery Extract Supplements and Their Effects on Lipid Peroxidation
NCT number | NCT04876261 |
Other study ID # | IK03-2020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 10, 2021 |
Est. completion date | July 2, 2021 |
Verified date | July 2021 |
Source | Daacro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this cross-over study is to assess the bioavailability of hydroxytyrosol in healthy males after the intake of two olive watery extract supplements and one olive oil. Blood and urine samples will be collected before and after intake of the investigational products. Sample will be analysed regarding the level of hydroxytyrosol and preventing lipid peroxidation.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 2, 2021 |
Est. primary completion date | July 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 50 Years |
Eligibility | Inclusion Criteria: - Self-reported healthy men aged 21-50, - subject has an adequate understanding of the study and signs the informed consent to participate in the study, - willingness to follow dietary and physical activity restrictions during study participation, - body mass index range: >18.5 and <29.9 kg/m2. Exclusion Criteria: - Any known allergies to IPs (olives and their derivates), - any acute and chronic diseases (e.g. diagnosis of diabetes mellitus, hypertension, dyslipidemia or other cardiometabolic disorders, diagnosed hepatic, renal, or cardiovascular disease), - any kind of eating disorders, - not fluent in German, - any previous (last 14 days prior to screening) and any ongoing pharmacological therapy (e.g. any medication, vaccination, infusion), - any intake of nutritional supplements, - any known addiction to drugs and/or alcohol, - smoker, - Investigator or physician doubts truthfulness of self-reported health information. |
Country | Name | City | State |
---|---|---|---|
Germany | daacro GmbH & Co. KG | Trier | Rhineland-Palatinate |
Lead Sponsor | Collaborator |
---|---|
Daacro | Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl., Institut Kurz GmbH, ISTITUTO KURZ ITALIA S.R.L. |
Germany,
Caruso D, Visioli F, Patelli R, Galli C, Galli G. Urinary excretion of olive oil phenols and their metabolites in humans. Metabolism. 2001 Dec;50(12):1426-8. — View Citation
Covas MI, de la Torre R, Fitó M. Virgin olive oil: a key food for cardiovascular risk protection. Br J Nutr. 2015 Apr;113 Suppl 2:S19-28. doi: 10.1017/S0007114515000136. Review. — View Citation
Covas MI, Nyyssönen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Bäumler H, Nascetti S, Salonen JT, Fitó M, Virtanen J, Marrugat J; EUROLIVE Study Group. The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial. Ann Intern Med. 2006 Sep 5;145(5):333-41. — View Citation
D'Angelo S, Manna C, Migliardi V, Mazzoni O, Morrica P, Capasso G, Pontoni G, Galletti P, Zappia V. Pharmacokinetics and metabolism of hydroxytyrosol, a natural antioxidant from olive oil. Drug Metab Dispos. 2001 Nov;29(11):1492-8. — View Citation
de Bock M, Thorstensen EB, Derraik JG, Henderson HV, Hofman PL, Cutfield WS. Human absorption and metabolism of oleuropein and hydroxytyrosol ingested as olive (Olea europaea L.) leaf extract. Mol Nutr Food Res. 2013 Nov;57(11):2079-85. doi: 10.1002/mnfr.201200795. Epub 2013 Jun 14. — View Citation
Hohmann CD, Cramer H, Michalsen A, Kessler C, Steckhan N, Choi K, Dobos G. Effects of high phenolic olive oil on cardiovascular risk factors: A systematic review and meta-analysis. Phytomedicine. 2015 Jun 1;22(6):631-40. doi: 10.1016/j.phymed.2015.03.019. Epub 2015 Apr 20. Review. — View Citation
Karkovic Markovic A, Toric J, Barbaric M, Jakobušic Brala C. Hydroxytyrosol, Tyrosol and Derivatives and Their Potential Effects on Human Health. Molecules. 2019 May 24;24(10). pii: E2001. doi: 10.3390/molecules24102001. Review. — View Citation
Mateos R, Martínez-López S, Baeza Arévalo G, Amigo-Benavent M, Sarriá B, Bravo-Clemente L. Hydroxytyrosol in functional hydroxytyrosol-enriched biscuits is highly bioavailable and decreases oxidised low density lipoprotein levels in humans. Food Chem. 2016 Aug 15;205:248-56. doi: 10.1016/j.foodchem.2016.03.011. Epub 2016 Mar 4. — View Citation
Miró-Casas E, Covas MI, Fitó M, Farré-Albadalejo M, Marrugat J, de la Torre R. Tyrosol and hydroxytyrosol are absorbed from moderate and sustained doses of virgin olive oil in humans. Eur J Clin Nutr. 2003 Jan;57(1):186-90. — View Citation
Suárez M, Valls RM, Romero MP, Macià A, Fernández S, Giralt M, Solà R, Motilva MJ. Bioavailability of phenols from a phenol-enriched olive oil. Br J Nutr. 2011 Dec;106(11):1691-701. doi: 10.1017/S0007114511002200. Epub 2011 Jun 21. — View Citation
Visioli F, Galli C, Bornet F, Mattei A, Patelli R, Galli G, Caruso D. Olive oil phenolics are dose-dependently absorbed in humans. FEBS Lett. 2000 Feb 25;468(2-3):159-60. — View Citation
Visioli F, Galli C, Grande S, Colonnelli K, Patelli C, Galli G, Caruso D. Hydroxytyrosol excretion differs between rats and humans and depends on the vehicle of administration. J Nutr. 2003 Aug;133(8):2612-5. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability of hydroxytyrosol in urine | The primary objective is the bioavailability of hydroxytyrosol and its derivatives from both food supplements (OliPhenolia® bitter and OliPhenolia®) in urine when compared to extra virgin olive oil. | -2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h | |
Primary | Bioavailability of hydroxytyrosol in blood | The primary objective is the bioavailability of hydroxytyrosol and its derivatives from both food supplements (OliPhenolia® bitter and OliPhenolia®) in urine when compared to extra virgin olive oil. | 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h | |
Secondary | Oxidative damages to lipids in blood | The secondary outcome is the measurement of the oxidized LDL(low-density lipoprotein) in blood | 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h | |
Secondary | changes in F2alpha-isoprostanes in urine | The secondary outcome is the measurement of changes in F2alpha-isoprostanes in urine. | -2 hrs to IP intake, 0 to 30 min, 30 to 60 min, 60 to 90 min, 90 to 120 min, 120 to 240 min and +4h to +12h |
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