Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285682
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2024-02-23
Brief Title:
Bioavailability of Hydroxytyrosol in Healthy Adult Humans
Sponsor:
Anglia Ruskin University
Organization:
Anglia Ruskin University
Study Overview
Official Title:
The Dose Response of a Commercially Available Olive Fruit Water OliPhenolia on the Bioavailability of Hydroxytyrosol and Its Metabolites Over a Four-hour Time Period in Healthy Adult Humans
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Brief summary There is current scientific interest in hydroxytyrosol due to its anti-inflammatory and antioxidant properties efficient protection of vascular tissue and ability to neutralise free radicals via hydrogen donation Recognised as the potent polyphenol within a commercially available olive-fruit water OliPhenolia data from this research will determine the dose of OliPhenolia required for the optimum absorption and metabolism of hydroxytyrosol The primary aim of this research is to identify the dose of hydroxytyrosol 05 10 or 15 mgkg-1 within OliPhenolia that demonstrates the greatest area under the plasma concentration curve for hydroxytyrosol over a four-hour period A secondary aim is to assess maximum concentration CMAX and time to maximum concentration TMAX of total hydroxytyrosol and secondary metabolites Tyrosol HT-3-glucoronide HT-3-sulphate 34-Dihydroxyphenylacetic Acid Homovanillic Acid and Oleuropein following consumption of 3 randomised doses of OliPhenolia on separate occasions with healthy adult volunteers
Detailed Description:
There is current and significant scientific interest in the use of plant-based polyphenol supplementation to support health protection against disease and recovery from exercise Recent literature dictates that daily supplementation 3d of 1000mg of polyphenols may enhance recovery from exercise and can therefore be associated with both an increased frequency of exercise and quality of movement The large proportion of research to date has focussed on certain fruit extracts blackcurrant tart Montmorency cherry or pomegranate juice however a recent study from our group utilising milled waste olive-water demonstrated that 16 days of supplementation may support recovery from exercise via the blunting of certain oxidative stress markers and enhance low-intensity exercise performance through a reduction in oxygen economy
To date there has been significant clinical research interest in the properties of waste-water produced when cold pressing olives which has been shown to contain high concentrations of natural polyphenols particularly hydroxytyrosol a potent scavenger of free radicals Fattoria La Vialla is an Italian-based organic farm producing various products including cold-pressed olive oil In doing so they also produce an olive waste-water extract which is commercially available as OliPhenolia and currently advertised as a health promoting supplement Whilst several clinical studies have been undertaken using this product to date there have been no studies investigating the dose response of OliPhenolia on the bioavailability of hydroxytyrosol and the secondary metabolites As such this study proposes to investigate the bioavailability of hydroxytyrosol across three doses of OliPhenolia 05 10 or 15mgkg-1 in a randomised manner to understand and therefore inform pertinent supplementation strategies to support health and components of exercise
Following a study briefing and provision of written informed consent participants will be required to attend the Human Physiology Laboratory at Cambridge Centre for Sport and Exercise Sciences Anglia Ruskin University on three occasions Each visit will follow an identical protocol providing an randomly assigned dose 05 10 or 15mgkg-1 of olive derived hydroxytyrosol from OliPhenolia based on body weight Participants will be required to complete a weighed food diary and adhere to a low-polyphenol diet for the three days prior to each visit as well as consume a standardised pre-visit evening meal the night before each visit Participants will arrive at each visit in a fasted 10h and hydrated state 500mL 1h prior to arrival Following a resting blood sample participants will consume one of the three doses of OliPhenolia and then remain in a comfortable supine position for the remainder of the visit Water will be provided at 90 and 180 minutes post OliPhenolia consumption
Blood samples - two 4mL wholeblood samples will be collected via cannulation at rest and then 2040 60 120 and 240 minutes following each dose Following collection blood samples will be immediately centrifuged with plasma allocated into separate cryovials pre treated with 150µL citric acid for the analysis of i the main polyphenol compound- hydroxytyrosol ii the secondary metabolites of hydroxytyrosol Tyrosol HT-3-glucoronide HT-3-sulphate 34-Dihydroxyphenylacetic Acid Homovanillic Acid and Oleuropein
Nutritional supplementation - all products will be suppliedcertified independently via Fattoria La Vialla Italy httpswwwoliphenoliaituk
To date there has been significant clinical research interest in the properties of waste-water produced when cold pressing olives which has been shown to contain high concentrations of natural polyphenols particularly hydroxytyrosol a potent scavenger of free radicals Fattoria La Vialla is an Italian-based organic farm producing various products including cold-pressed olive oil In doing so they also produce an olive waste-water extract which is commercially available as OliPhenolia and currently advertised as a health promoting supplement Whilst several clinical studies have been undertaken using this product to date there have been no studies investigating the dose response of OliPhenolia on the bioavailability of hydroxytyrosol and the secondary metabolites As such this study proposes to investigate the bioavailability of hydroxytyrosol across three doses of OliPhenolia 05 10 or 15mgkg-1 in a randomised manner to understand and therefore inform pertinent supplementation strategies to support health and components of exercise
Following a study briefing and provision of written informed consent participants will be required to attend the Human Physiology Laboratory at Cambridge Centre for Sport and Exercise Sciences Anglia Ruskin University on three occasions Each visit will follow an identical protocol providing an randomly assigned dose 05 10 or 15mgkg-1 of olive derived hydroxytyrosol from OliPhenolia based on body weight Participants will be required to complete a weighed food diary and adhere to a low-polyphenol diet for the three days prior to each visit as well as consume a standardised pre-visit evening meal the night before each visit Participants will arrive at each visit in a fasted 10h and hydrated state 500mL 1h prior to arrival Following a resting blood sample participants will consume one of the three doses of OliPhenolia and then remain in a comfortable supine position for the remainder of the visit Water will be provided at 90 and 180 minutes post OliPhenolia consumption
Blood samples - two 4mL wholeblood samples will be collected via cannulation at rest and then 2040 60 120 and 240 minutes following each dose Following collection blood samples will be immediately centrifuged with plasma allocated into separate cryovials pre treated with 150µL citric acid for the analysis of i the main polyphenol compound- hydroxytyrosol ii the secondary metabolites of hydroxytyrosol Tyrosol HT-3-glucoronide HT-3-sulphate 34-Dihydroxyphenylacetic Acid Homovanillic Acid and Oleuropein
Nutritional supplementation - all products will be suppliedcertified independently via Fattoria La Vialla Italy httpswwwoliphenoliaituk
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?:
False
Is an FDA AA801 Violation?:
None