Biological AvailabilityNCT04876261
Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements
A study testing Oliphenolia® bitter, Oliphenolia® and La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol in people with Biological Availability, run by Daacro at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Biological Availability
- What is being tested?
- Oliphenolia® bitter, Oliphenolia® and La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2021to 2 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- any known addiction to drugs and/or alcohol,
- smoker,
- Investigator or physician doubts truthfulness of self-reported health information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Hydroxytyrosol From Two Olive Watery Extract Supplements and Their Effects on Lipid Peroxidation
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.
Read the 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 D'Angelo and collaborators [D'Angelo 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 (e.g. 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.
- Conditions
- Biological Availability
- Being tested
- Oliphenolia® bitter, Oliphenolia®, La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol
- Keywords
- Olives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliphenolia® bitterDietary supplement
- ingredients: concentrated watery extract of olives 94%, lemon juice 6%
- 35 mg hydroxytyrosol, 0,24 mg Oleuropein
Oliphenolia®Dietary supplement
- ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30%
- 38 mg hydroxytyrosol, 0,28 mg Oleuropein
La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosolDietary supplement
- extra virgin olive oil
- 5 mg hydroxytyrosol
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A will receive Oliphenolia® bitter on intervention visit 1 followed by Oliphenolia® on intervention visit 2 and followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on the third and final intervention visit Receives: Dietary Supplement: Oliphenolia® bitter; Dietary Supplement: Oliphenolia®; Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol |
| Group B | Active comparator | Group B will receive Oliphenolia® on intervention visit 1 followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 2 and followed by Oliphenolia® bitter on the third and final intervention visit Receives: Dietary Supplement: Oliphenolia® bitter; Dietary Supplement: Oliphenolia®; Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol |
| Group C | Active comparator | Group C will receive La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 1 followed by Oliphenolia® bitter on intervention visit 2 and followed by Oliphenolia® on the third and final intervention visit Receives: Dietary Supplement: Oliphenolia® bitter; Dietary Supplement: Oliphenolia®; Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -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
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.
Measured: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
Secondary outcomes (2)
Oxidative damages to lipids in blood
The secondary outcome is the measurement of the oxidized LDL(low-density lipoprotein) in blood
Measured: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
changes in F2alpha-isoprostanes in urine
The secondary outcome is the measurement of changes in F2alpha-isoprostanes in urine.
Measured: -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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start10 May 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Biological AvailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three-armed study with a cross-over design. Participants will be randomly assigned to either group A, B or C. The group allocation will define the sequence of product intake: * Group A: first OliPhenolia® bitter, second OliPhenolia®, third La Vialla Extra Virgin Olive Oil * Group B: first OliPhenolia®, second La Vialla Extra Virgin Olive Oil, third OliPhenolia® bitter * Group C: first La Vialla Extra Virgin Olive Oil, second OliPhenolia® bitter, third OliPhenolia®
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daacro
- Sponsor type
- Research network
- Collaborators
- ISTITUTO KURZ ITALIA S.R.L., Institut Kurz GmbH, Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.
- Responsible party
- Sponsor
- Investigators
- Juliane Hellhammer, PhD, Principal investigator, Daacro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876261
- Sponsor's protocol ID
- IK03-2020
- Status last verified
- Jul 2021
- First submitted
- 3 May 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11602527Caruso 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. doi: 10.1053/meta.2001.28073.
PubMed 11735087Covas MI, Nyyssonen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Baumler H, Nascetti S, Salonen JT, Fito 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. doi: 10.7326/0003-4819-145-5-200609050-00006.
PubMed 16954359Covas MI, de la Torre R, Fito 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.
PubMed 26148918de 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.
PubMed 23766098Hohmann 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.
PubMed 26055128Karkovic Markovic A, Toric J, Barbaric M, Jakobusic Brala C. Hydroxytyrosol, Tyrosol and Derivatives and Their Potential Effects on Human Health. Molecules. 2019 May 24;24(10):2001. doi: 10.3390/molecules24102001.
PubMed 31137753Mateos R, Martinez-Lopez S, Baeza Arevalo G, Amigo-Benavent M, Sarria 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.
PubMed 27006237Miro-Casas E, Covas MI, Fito M, Farre-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. doi: 10.1038/sj.ejcn.1601532.
PubMed 12548315Suarez M, Valls RM, Romero MP, Macia A, Fernandez S, Giralt M, Sola 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.
PubMed 21736768Visioli 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. doi: 10.1016/s0014-5793(00)01216-3.
PubMed 10692578Visioli 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. doi: 10.1093/jn/133.8.2612.
PubMed 12888646
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Hydroxytyrosol From Two Olive Watery Extract Supplements and Their Effects on Lipid Peroxidation
- ClinicalTrials.gov ID
- NCT04876261
- Acronym / sponsor ID
- IK03-2020
- Conditions
- Biological Availability
- Keywords
- Olives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- DaacroResearch network
- Collaborators
- ISTITUTO KURZ ITALIA S.R.L., Institut Kurz GmbH, Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.
- Study start
- 10 May 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 D'Angelo and collaborators [D'Angelo 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 (e.g. 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-armed study with a cross-over design. Participants will be randomly assigned to either group A, B or C. The group allocation will define the sequence of product intake: * Group A: first OliPhenolia® bitter, second OliPhenolia®, third La Vialla Extra Virgin Olive Oil * Group B: first OliPhenolia®, second La Vialla Extra Virgin Olive Oil, third OliPhenolia® bitter * Group C: first La Vialla Extra Virgin Olive Oil, second OliPhenolia® bitter, third OliPhenolia®
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: Oliphenolia® bitter, Dietary Supplement: Oliphenolia®, Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosolGroup A will receive Oliphenolia® bitter on intervention visit 1 followed by Oliphenolia® on intervention visit 2 and followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on the third and final intervention visit |
| Group B | Active comparator | Dietary Supplement: Oliphenolia® bitter, Dietary Supplement: Oliphenolia®, Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosolGroup B will receive Oliphenolia® on intervention visit 1 followed by La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 2 and followed by Oliphenolia® bitter on the third and final intervention visit |
| Group C | Active comparator | Dietary Supplement: Oliphenolia® bitter, Dietary Supplement: Oliphenolia®, Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosolGroup C will receive La Vialla Extra Virgin Olive Oil with 5 mg hydroxytyrosol on intervention visit 1 followed by Oliphenolia® bitter on intervention visit 2 and followed by Oliphenolia® on the third and final intervention visit |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oliphenolia® bitter* ingredients: concentrated watery extract of olives 94%, lemon juice 6% * 35 mg hydroxytyrosol, 0,24 mg Oleuropein | Dietary supplement | Group A, Group B, Group C |
| Oliphenolia®* ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30% * 38 mg hydroxytyrosol, 0,28 mg Oleuropein | Dietary supplement | Group A, Group B, Group C |
| La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol* extra virgin olive oil * 5 mg hydroxytyrosol | Dietary supplement | Group A, Group B, Group C |
Primary outcome
Bioavailability of hydroxytyrosol in urine
Time frame: -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
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.
Bioavailability of hydroxytyrosol in blood
Time frame: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
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 secondary outcomes
Oxidative damages to lipids in blood
Time frame: 5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h
changes in F2alpha-isoprostanes in urine
Time frame: -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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Background: PubMed 11602527D'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.
- Background: PubMed 11735087Caruso 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. doi: 10.1053/meta.2001.28073.
- Background: PubMed 16954359Covas MI, Nyyssonen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Baumler H, Nascetti S, Salonen JT, Fito 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. doi: 10.7326/0003-4819-145-5-200609050-00006.
- Background: PubMed 26148918Covas MI, de la Torre R, Fito 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.
- Background: PubMed 23766098de 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.
- Background: PubMed 26055128Hohmann 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.
- Background: PubMed 31137753Karkovic Markovic A, Toric J, Barbaric M, Jakobusic Brala C. Hydroxytyrosol, Tyrosol and Derivatives and Their Potential Effects on Human Health. Molecules. 2019 May 24;24(10):2001. doi: 10.3390/molecules24102001.
- Background: PubMed 27006237Mateos R, Martinez-Lopez S, Baeza Arevalo G, Amigo-Benavent M, Sarria 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.
- Background: PubMed 12548315Miro-Casas E, Covas MI, Fito M, Farre-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. doi: 10.1038/sj.ejcn.1601532.
- Background: PubMed 21736768Suarez M, Valls RM, Romero MP, Macia A, Fernandez S, Giralt M, Sola 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.
- Background: PubMed 10692578Visioli 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. doi: 10.1016/s0014-5793(00)01216-3.
- Background: PubMed 12888646Visioli 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. doi: 10.1093/jn/133.8.2612.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliane Hellhammer, PhD principal investigator
Daacro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oliphenolia® bitter, Oliphenolia® and La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol in people with Biological Availability, run by Daacro at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of hydroxytyrosol in urine (time frame: -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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876261, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.