- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01790672
Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
Hydroxytyrosol as an Endogenous and Natural Antioxidant: Modulation by Alcohol Intake. Substudy 2. To Establish the Contribution of Wine Components on Hydroxytyrosol Body Concentrations and Biological Effects
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08003
- Parc de Salut Mar
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Understanding and accepting the study procedures and signing the informed consent.
- Male and female volunteers aged 18 to 55 years. No fixed sex ratio has been established.
- 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.
- The body mass index (BMI=weigh/height2) will range from 19 to 25 kg/m2, and the weight from 50 to 100 kg. 25-27 could be accepted.
- Women with regular menstrual cycle of 26-32 days.
- Subjects socially drinking and who had ingested wine at least once.
Exclusion Criteria:
- Not meeting the inclusion criteria.
- History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
- Blood donation in the previous 8 weeks or participation in other clinical trials with drugs in the previous 12 weeks.
- Having suffered any organic disease or major surgery in the three months prior to the study start.
- Subjects with intolerance or serious adverse reactions to ethanol.
- Regular use of any drug in the month prior to the study sessions, except for vitamins or diet supplements, that, in the opinion of the principal investigator or co-investigators designated by him, do not involve a risk for the subject and do not interfere with the study objectives. In this case they should be discontinued from one week before the experimental sessions to the end of them. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- Taking more than 20 g of alcohol a day in women and more than 30 g in men.
- Taking more than 5 coffees, teas, cola drinks or other stimulating drinks or with xanthines daily in the 3 months prior to the study start.
- Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- Smokers or ex-smokers of less than one year.
- Subjects with positive serology to Hepatitis B, C or HIV.
- Pregnant or nursing women or positive pregnancy test in urine. Women not undertaking to follow reliable contraceptive measures during the study (such as abstinence, hormonal contraceptives, intrauterine devices, double-barrier methods or vasectomised partner).
- Women with amenorrhea or premenstrual syndrome of moderate or severe intensity.
- Nonsteroidal anti-inflammatory drugs, antioxidants or vitamins consumption in the last 2 weeks.
- Total cholesterol >6.00 mmol/l (240 mg/dl) or triglycerides >2.26 mmol/l (200 mg/dl).
- Vegetarians or subjects following aberrant diets.
- Physical exercise of >2h/day or >3000 kcal /week.
To be eligible, the subjects must agree to follow a poor polyphenols diet in the 72 hours prior to the start of each session and until 24 hours after.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Water
Lemon-flavored water.
293 ml in pilot A, 147 ml in pilot B, 235 ml in pilot C, 147 ml in the definitive study.
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Lemon-flavored water
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Comparador activo: Alcoholized wine
Wine 13º in pilot A (293 ml), B (147 ml) and the definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and 15 g of ethanol in the definitive study. Wine 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. |
Wine 13º or wine 8º
|
Comparador de placebos: De-alcoholized wine
Wine 0º.
Pilot A: 293ml; pilot B: 147 ml; pilot C: 235 ml; definitive study: 147 ml.
Corresponding to 0 g of ethanol.
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Wine 0º
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Comparador activo: Ethanol
Ethanol 13º in pilot A (293 ml), B (147 ml) and definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and in the definitive study. Ethanol 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. Ethanol was administered as a single dose of Vodka Absolut (40º) diluted in lemon-flavored water. |
Vodka Absolut
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Concentraciones de fluidos biológicos de hidroxitirosol
Periodo de tiempo: 0-24h después de la administración
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Concentraciones de hidroxitirosol en plasma y orina
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0-24h después de la administración
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Embriaguez subjetiva
Periodo de tiempo: 0-6h después de la administración
|
Efectos subjetivos del etanol medidos con una escala analógica visual
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0-6h después de la administración
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Concentración de etanol
Periodo de tiempo: 0-6h después de la administración
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Concentraciones de etanol en sangre
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0-6h después de la administración
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Concentraciones de metabolitos de etanol
Periodo de tiempo: 0-24h después de la administración
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Recuperación de metabolitos de etanol en orina
|
0-24h después de la administración
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Concentraciones de metabolitos de dopamina
Periodo de tiempo: 0-24h después de la administración
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Recuperación de metabolitos de dopamina en orina
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0-24h después de la administración
|
Vital signs
Periodo de tiempo: 0-24h after administration
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Blood pressure, oral temperature and heart rate
|
0-24h after administration
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Oxidation biomarkers of proteins and lipids
Periodo de tiempo: 0-24h after administration
|
0-24h after administration
|
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Psychomotor performance (DSST)
Periodo de tiempo: 0-6h after administration
|
Psychomotor performance assessed by means of Digit symbol substitution test (DSST)
|
0-6h after administration
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Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence
Periodo de tiempo: Baseline
|
Baseline
|
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Platelets monoamine oxidase-B activity
Periodo de tiempo: Baseline
|
Baseline
|
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Breath ethanol
Periodo de tiempo: 30 min after administration
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Breath ethanol concentration
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30 min after administration
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Magí Farré, MD, PhD, Parc de Salut Mar
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Hydroxytyrosol/FIS/2
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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