Human Study of Hydroxytyrosol on Phase II Enzymes in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 30 March 2015
• Main ID: NCT02273622
• Date of registration: 15/10/2014
• Prospective Registration: No
• Primary sponsor: IMDEA Food
• Public title: Human Study of Hydroxytyrosol on Phase II Enzymes in Healthy Subjects
• Scientific title: Nutritional Intervention Study to Evaluate the Effect of Hydroxytyrosol on Phase II Enzymes in Healthy Subjects
• Date of first enrolment: October 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02273622
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Francesco Visioli, Prof
• Affiliation: IMDEA Food

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male gender with age range 20-40 years

- Signed patient informed consent

Exclusion Criteria:

- 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.



Age minimum: 20 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Dietary Supplement: placebo

Dietary Supplement: hydroxytyrosol

Primary Outcome(s)

Detoxifying potential of hydroxytyrosol and its effects on Phase II enzyme expression (leading to xenobiotics detoxification in the liver). [Time Frame: Change of Baseline and after one week hydroxytyrosol and placebo administration]

Secondary Outcome(s)

Number of participants with change in different anthropometrics parameters [Time Frame: Change of Baseline and after one week hydroxytyrosol and placebo administration]

Number of participants with change in different biochemical parameters [Time Frame: Change of Baseline and after one week hydroxytyrosol and placebo administration]

Concentration of hydroxytyrosol and metabolites in urine [Time Frame: Change of Baseline and after one week hydroxytyrosol and placebo administration]

Secondary ID(s)

IMD PI011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors