Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876261
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2021-05-03
Brief Title:
Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements
Sponsor:
Daacro
Organization:
Daacro
Study Overview
Official Title:
Bioavailability of Hydroxytyrosol From Two Olive Watery Extract Supplements and Their Effects on Lipid Peroxidation
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Background
Hydroxytyrosol is a phenolic phytochemical naturally occurring in olives with potential antioxidant anti-inflammatory and health benefits mainly related with cardiovascular diseases for review see Covas et al 2015 OliPhenolia bitter and OliPhenolia are two food supplements resulting from the liquid by-product generated during olive oil production that are rich in olive polyphenols mainly hydroxytyrosol Hydroxytyrosol and its derivatives tyrosol and oleuropein are present in higher levels in the watery extracts from olives when compared with the oil fraction
Most studies on hydroxytyrosol bioavailability have been performed by consuming it with olive oil or as a highly purified molecule In a study by DAngelo and collaborators DAngelo et al 2001 it was shown that hydroxytyrosol can be rapidly absorbed from the blood and distributed in the human body metabolized and eliminated rapidly in urine mainly as a glucuronide It has been estimated that the absorption process depends on the composition of the food matrix through which hydroxytyrosol is administered Visioli et al 2003 when consumed together with fats eg olive oil it is absorbed in a greater extent By being a water-soluble molecule hydroxytyrosol is only slightly soluble in fats therefore naturally present in significantly higher concentrations in the olive fruit aqueous fractions than in the olive oil
Overall the human studies support the need to evaluate the bioavailability of hydroxytyrosol following its administration as a major component of the two aqueous food supplements OliPhenolia and OliPhenolia bitter
Study Procedure
After detailed information and signed informed consent all males meeting the inclusion and exclusion criteria will be included into the study During their study participation participants are not allowed to consume any products with or made from olives or olive oil as well as alcohol and supplements with hydroxytyrosol vitamins minerals and antioxidants Products high in polyphenols and antioxidants may only be consumed in moderate amounts Three days prior to and at each intervention day volunteers will be requested to avoid moderate or intense physical activity
After a run-in period participants will return in a fasted state to the site for the first intervention visit Volunteers will be asked to empty their bladder at home 2h before IP intake After arriving at the site a baseline blood and urine sample -5 min will be collected and the participants receive according to the individual allocation determining the sequence of the IP intake either one of the olive watery extract supplements OliPhenolia bitter or OliPhenolia or the olive oil first Further blood and urine samples will follow 30 min 60 min 90 min 120 min 240 min 12 h Vital signs and AEs will be checked throughout the intervention visit Participants will receive several snacks and water during their visit
After a one-week washout phase each participants will return to their second and third intervention visit The same procedures as on intervention visit 1 will take place except the IP intake will vary according to the individual allocation
At the end of the third intervention visit participants will receive a study compensation
Hydroxytyrosol is a phenolic phytochemical naturally occurring in olives with potential antioxidant anti-inflammatory and health benefits mainly related with cardiovascular diseases for review see Covas et al 2015 OliPhenolia bitter and OliPhenolia are two food supplements resulting from the liquid by-product generated during olive oil production that are rich in olive polyphenols mainly hydroxytyrosol Hydroxytyrosol and its derivatives tyrosol and oleuropein are present in higher levels in the watery extracts from olives when compared with the oil fraction
Most studies on hydroxytyrosol bioavailability have been performed by consuming it with olive oil or as a highly purified molecule In a study by DAngelo and collaborators DAngelo et al 2001 it was shown that hydroxytyrosol can be rapidly absorbed from the blood and distributed in the human body metabolized and eliminated rapidly in urine mainly as a glucuronide It has been estimated that the absorption process depends on the composition of the food matrix through which hydroxytyrosol is administered Visioli et al 2003 when consumed together with fats eg olive oil it is absorbed in a greater extent By being a water-soluble molecule hydroxytyrosol is only slightly soluble in fats therefore naturally present in significantly higher concentrations in the olive fruit aqueous fractions than in the olive oil
Overall the human studies support the need to evaluate the bioavailability of hydroxytyrosol following its administration as a major component of the two aqueous food supplements OliPhenolia and OliPhenolia bitter
Study Procedure
After detailed information and signed informed consent all males meeting the inclusion and exclusion criteria will be included into the study During their study participation participants are not allowed to consume any products with or made from olives or olive oil as well as alcohol and supplements with hydroxytyrosol vitamins minerals and antioxidants Products high in polyphenols and antioxidants may only be consumed in moderate amounts Three days prior to and at each intervention day volunteers will be requested to avoid moderate or intense physical activity
After a run-in period participants will return in a fasted state to the site for the first intervention visit Volunteers will be asked to empty their bladder at home 2h before IP intake After arriving at the site a baseline blood and urine sample -5 min will be collected and the participants receive according to the individual allocation determining the sequence of the IP intake either one of the olive watery extract supplements OliPhenolia bitter or OliPhenolia or the olive oil first Further blood and urine samples will follow 30 min 60 min 90 min 120 min 240 min 12 h Vital signs and AEs will be checked throughout the intervention visit Participants will receive several snacks and water during their visit
After a one-week washout phase each participants will return to their second and third intervention visit The same procedures as on intervention visit 1 will take place except the IP intake will vary according to the individual allocation
At the end of the third intervention visit participants will receive a study compensation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None