Human Study of Hydroxytyrosol on Phase II Enzymes in Healthy Subjects

NCT02273622 | Completed

• 1 other identifier: IMD PI011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme expression (leading to xenobiotics detoxification in the liver).

Conditions

Healthy

Keywords

hydroxytyrosol; dietary supplement; gene expression regulation

Outcome Measures

Primary Outcomes (1)

• Detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme expression (leading to xenobiotics detoxification in the liver).

  The analyses of gene expression will be carried out at the ad-hoc platform in use at IMDEA-Food (see www.food.imdea.org for details). Total RNA will be extracted from mononuclear cells with TRI Reagent (Sigma-Aldrich, Inc., St. Louis, MO, USA) and purified with RNeasy MiniElute Cleanup Kit (Qiagen, Hilden, Germany). Recovered RNA will be quantified using a Nanodrop ND-1000 v3.5.2 spectrophotometer (Nanodrop TechnologyR, Cambridge, UK). RNA integrity will be assessed using 1.6% agarose gel, 1× TBE. RNA will be judged suitable for array hybridization only if samples exhibited intact bands corresponding to 18S and 28S ribosomal RNAs. During the study blood samples will be obtained from venous puncture and blood samples will be collected in tubes containing EDTA, maintained on ice and rapidly centrifuged to obtain plasma. Plasma will be immediately distributed in aliquots for the different determinations and stored at -70 °C until analysis.

  Change of Baseline and after one week hydroxytyrosol and placebo administration

Secondary Outcomes (3)

• Number of participants with change in different anthropometrics parameters

  Change of Baseline and after one week hydroxytyrosol and placebo administration

• Number of participants with change in different biochemical parameters

  Change of Baseline and after one week hydroxytyrosol and placebo administration

• Concentration of hydroxytyrosol and metabolites in urine

  Change of Baseline and after one week hydroxytyrosol and placebo administration

Study Arms (3)

hydroxytyrosol 5 mg

EXPERIMENTAL

each participant will alternately by the three arms of the study (hydroxytyrosol 5 mg and 20 mg and placebo

Dietary Supplement: hydroxytyrosol

hydroxytyrosol 20 mg

EXPERIMENTAL

each participant will alternately by the three arms of the study (hydroxytyrosol 5 mg and 20 mg and placebo

Dietary Supplement: hydroxytyrosol

placebo

PLACEBO COMPARATOR

each participant will alternately by the three arms of the study (hydroxytyrosol 5 mg and 20 mg and placebo

Dietary Supplement: placebo

Interventions

hydroxytyrosol DIETARY_SUPPLEMENT

Pilot study with 20 participants, each participant will alternately by the two arms of the study (hydroxytyrosol 5 mg and 20 mg) and control, during 6 weeks.

hydroxytyrosol 20 mg; hydroxytyrosol 5 mg

placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male gender with age range 20-40 years
• Signed patient informed consent

You may not qualify if:

• BMI \< 19 and \>26
• Subjects with a diagnosis of diabetes mellitus, dyslipidemia, hypertension and other cardiometabolic diseases.
• Subjects with dementia, mental illness or diminished cognitive function.
• Subjects with serious diseases (hepatic, renal, cardiovascular, etc.)
• Subjects who refuse to make the 24 hour urine collection and blood samples under study.
• Subjects with allergy or intolerance to olive and derivatives.
• Subjects with drug treatment of any kind.
• Current smoking.

Sponsors & Collaborators

• IMDEA Food: lead

Study Sites (1)

IMDEA-Food

Madrid, Madrid, 28049, Spain

Location

Related Publications (5)

• Visioli F, Galli C, Plasmati E, Viappiani S, Hernandez A, Colombo C, Sala A. Olive phenol hydroxytyrosol prevents passive smoking-induced oxidative stress. Circulation. 2000 Oct 31;102(18):2169-71. doi: 10.1161/01.cir.102.18.2169.

  PMID: 11056087 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, Caruso D, Plasmati E, Patelli R, Mulinacci N, Romani A, Galli G, Galli C. Hydroxytyrosol, as a component of olive mill waste water, is dose- dependently absorbed and increases the antioxidant capacity of rat plasma. Free Radic Res. 2001 Mar;34(3):301-5. doi: 10.1080/10715760100300271.

  PMID: 11264904 BACKGROUND

• Visioli F, Bellosta S, Galli C. Oleuropein, the bitter principle of olives, enhances nitric oxide production by mouse macrophages. Life Sci. 1998;62(6):541-6. doi: 10.1016/s0024-3205(97)01150-8.

  PMID: 9464466 BACKGROUND

• Crespo MC, Tome-Carneiro J, Burgos-Ramos E, Loria Kohen V, Espinosa MI, Herranz J, Visioli F. One-week administration of hydroxytyrosol to humans does not activate Phase II enzymes. Pharmacol Res. 2015 May-Jun;95-96:132-7. doi: 10.1016/j.phrs.2015.03.018. Epub 2015 Mar 30.

  PMID: 25836918 DERIVED

MeSH Terms

Interventions

3,4-dihydroxyphenylethanol

Study Officials

• Francesco Visioli, Prof

  IMDEA Food

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2014-10

Locations

ES (1)