Bioavailability of Hydroxytyrosol From Olive Watery Extract Supplements

NCT04876261 | Completed

• 1 other identifier: IK03-2020
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Biological Availability

Keywords

Olives

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Oxidative damages to lipids in blood

  5 min. before IP intake, 30, 60, 90, 120, 240 min and 12 h

• 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

Study Arms (3)

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

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

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

Dietary Supplement: Oliphenolia® bitter; Dietary Supplement: Oliphenolia®; Dietary Supplement: La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol

Interventions

Oliphenolia® bitter DIETARY_SUPPLEMENT

* ingredients: concentrated watery extract of olives 94%, lemon juice 6% * 35 mg hydroxytyrosol, 0,24 mg Oleuropein

Group A; Group B; Group C

Oliphenolia® DIETARY_SUPPLEMENT

* ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30% * 38 mg hydroxytyrosol, 0,28 mg Oleuropein

Group A; Group B; Group C

La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol DIETARY_SUPPLEMENT

* extra virgin olive oil * 5 mg hydroxytyrosol

Group A; Group B; Group C

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daacro: lead
• ISTITUTO KURZ ITALIA S.R.L.: collaborator
• Institut Kurz GmbH: collaborator
• Fattoria La Vialla di Gianni, Antonio e Bandino Lo Franco Soc. Agr. Sempl.: collaborator

Study Sites (1)

daacro GmbH & Co. KG

Trier, Rhineland-Palatinate, 54296, Germany

Location

Related Publications (12)

• 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.

  PMID: 11602527 BACKGROUND

• 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. doi: 10.1053/meta.2001.28073.

  PMID: 11735087 BACKGROUND

• Covas 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.

  PMID: 16954359 BACKGROUND

• Covas 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.

  PMID: 26148918 BACKGROUND

• 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.

  PMID: 23766098 BACKGROUND

• 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.

  PMID: 26055128 BACKGROUND

• Karkovic 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.

  PMID: 31137753 BACKGROUND

• Mateos 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.

  PMID: 27006237 BACKGROUND

• Miro-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.

  PMID: 12548315 BACKGROUND

• Suarez 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.

  PMID: 21736768 BACKGROUND

• 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. doi: 10.1016/s0014-5793(00)01216-3.

  PMID: 10692578 BACKGROUND

• 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. doi: 10.1093/jn/133.8.2612.

  PMID: 12888646 BACKGROUND

MeSH Terms

Interventions

3,4-dihydroxyphenylethanol

Study Officials

• Juliane Hellhammer, PhD

  Daacro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the laboratory will be blinded. Laboratory staff will be unblinded after samples are being analysed. Participants will be unblinded after study end.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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®

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: May 10, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)