Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06285682 |
| Other study ID # |
ETH2324-2826 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2024 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Anglia Ruskin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 (0.5, 1.0 or 1.5 mg∙kg-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, 3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein) following
consumption of 3 randomised doses of OliPhenolia® on separate occasions with healthy adult
volunteers.
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 >1,000mg 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® (0.5, 1.0 or 1.5mg∙kg-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 (0.5, 1.0 or 1.5mg∙kg-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
20,40, 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,
3,4-Dihydroxyphenylacetic Acid, Homovanillic Acid and Oleuropein).
Nutritional supplementation - all products will be supplied/certified independently via
Fattoria La Vialla, Italy (https://www.oliphenolia.it/uk/).
