Effects on Cardiovascular Risk Factors of the Endogenous Hydroxytyrosol Generation After the Combined Intake of Wine and Tyrosol in Humans

NCT02783989 | Completed

• 1 other identifier: IMIMFTCLFT/DOPET/3
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will assess whether the beneficial effects of a market moderate-alcohol drinking in the form of white wine in humans could be derived from the endogenous formation of hydroxytyrosol (also known DOPET), a potent dietary anti-inflammatory and antioxidant molecule.

Conditions

Cardiovascular Disease

Keywords

Endothelial function; Inflammation; Genes related to vascular risk

Outcome Measures

Primary Outcomes (3)

• Metabolic: changes in hydroxytyrosol generation

  Hydroxytyrosol generation from tyrosol ingestion in urine (24 hours urine collection)

  change from baseline at 4 weeks

• Vascular effects: changes in endothelial function

  It will be measured in the morning by monitoring endothelium-mediated changes in the digital pulse waveform, known as the Peripheral Arterial Tone (PAT) signal.

  change from baseline at 4 weeks

• Metabolic effects (n=12)

  Additionally, 12 participants will be asked to collect a 24-hour urine specimen at two intervals (0-8 h and 8-24 h) the first day of each intervention, following the treatment ingestion (n=12).

  up to 24 hours

Secondary Outcomes (10)

• changes in glucose profile

  change from baseline at 4 weeks

• changes in lipid profile

  change from baseline at 4 weeks

• changes in lipid profile

  change from baseline at 4 weeks

• changes in lipid profile

  change from baseline at 4 weeks

• changes in lipid profile

  change from baseline at 4 weeks

Other Outcomes (1)

• Liver function test

  through study completion, an average of 6 months

Study Arms (3)

White wine

ACTIVE COMPARATOR

Two glasses of a market white wine (2x135 mL, 13º), each (135 mL) equivalent to 14 g of ethanol (in case of women only one glass, 135 mL), being the daily dose of 28 g (14 g in women). It is estimated that wine will contain about 8-9 mg/l of tyrosol. Therefore the dose of tyrosol ingested in two glasses would be 2-2.5 mg (1-1.25 mg in women).

Other: white wine

White wine plus tyrosol capsules

EXPERIMENTAL

Two glasses of white wine (2x135 mL, 13º), each (135 mL) equivalent to 14 g of ethanol (in case of women only one glass, 135 mL), being the daily dose of 28 g (14g in women), in combination with capsules of 25 mg of TYR (each one to be ingested with a glass of wine), two capsules along the day for men (at lunch and at dinner) and one for woman (at lunch).

Other: white wine; Dietary Supplement: tyrosol

Water

NO INTERVENTION

Drinking water along with meals

Interventions

white wine OTHER

A dietary beverage: a market white wine, 13º alcohol

White wine; White wine plus tyrosol capsules

tyrosol DIETARY_SUPPLEMENT

tyrosol in capsules

White wine plus tyrosol capsules

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding and accepting the study procedures and signing the informed consent.
• Male and female volunteers aged 50 to 80 years.
• Participants with at least three major cardiovascular risk factors, including:
• current smoking (\>1 cig/day during the last month)
• hypertension ≥140/90 mmHg or antihypertensive medication
• low-density lipoprotein (LDL)-cholesterol \>130 mg/dl or lipid-lowering therapy
• low high-density lipoprotein (HDL)-cholesterol ≤40 mg/dl in men or ≤50 mg/dl in women
• overweight/obesity (body mass index≥25 kg/m2)
• a family history of premature coronary heart disease (CHD).
• Clinical diagnosis of type 2 diabetes.
• Clinical history and physical examination demonstrating no organic or psychiatric disorders.
• The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
• Subjects socially drinking and who had ingested wine at least once.
• Acceptance of following a controlled diet with a moderate content of antioxidants along the study, in which time it will be not permitted the consumption of wine/champagne (except in the framework of treatment conditions in the clinical trial) or other alcoholic drinks (beer, spirits…), but it will be allowed a maximum of:
• (i) Vegetables (including pulses): one serving (small dish)/day; (ii) Fruits (or juices): 2 pieces/day; (iii) Commercial olive oil: maximum 25 mL/day; (iv) Drinks containing xanthines (coffee, tea, cola, energy drinks…): maximum 3 cups/day; (v) Chocolate: maximum one piece (small, 15 gr)/day; (vi) Nuts: maximum 30 g (a small handful)/week; and (vii) Fish: maximum 3 times per week (150g/serving).

You may not qualify if:

• Participants with BMI \>40kg/m2
• Participants who intake antioxidant supplements.
• Participants with multiple allergies or intestinal diseases.
• Participants who follow special diets (vegetarian and vegan diets included).
• Participants with any condition limiting their mobility, making study visits impossible or worsening the adherence to the treatments.
• Participants with history of hypersensitivity or intolerance to ethanol.
• Ethanol users of \>80 g/d (v) and illicit drug users.
• Illiteracy.
• Participants with an acute infection or inflammatory process in the last three months (may be included if the episode developed prior to 3 months).
• Participants with history of previous cardiovascular disease (coronary heart disease or stroke)
• Participants taking medication with sedative effects or interacting with ethanol.
• Participation in other clinical trials with drugs in the previous 12 weeks

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

IMIM (Hospital del Mar Medical Research Institute)

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Inflammation

Interventions

4-hydroxyphenylethanol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rafael De la Torre Fornell, Pharm, PhD

  IMIM-Hospital del Mar Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharm D

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 26, 2016
• Study Start: January 20, 2016
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

ES (1)