Bioavailability and Bioactivity of Red Wine Melatonin in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

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Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of red wine. Twelve healthy volunteers were recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design. Serum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be analyzed.

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Detailed Description

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Melatonin (MLT) is a bioactive compound in red wine. No information is currently available on serum and salivary concentrations of MLT after drinking a glass of red wine, containing this indoleamine. Hence, in this study, the investigators will investigate the levels of MLT, in serum and saliva, soon after the intake of the MLT-rich red wine, and, correspondingly, they will verify the antioxidant power of the same biological fluids.

This will be a randomized, crossover, double-blind, placebo-controlled study with two treatment arms. Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1) and without MLT (placebo), via a randomized, cross-over, and double-blind design.

Serum and salivary MLT will be measured by liquid chromatography coupled to mass spectrometry (LC-MS) and enzyme-linked immunosorbent (ELISA), respectively. The ferric ion reducing antioxidant power (FRAP) will be also analyzed.

For serum analyses, samples will be collected at 0, 30, 60 and 90 min. For saliva analyses, samples will be collected at 0, 45 and 120 min.

Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Red wine with Melatonin

Rosso di Marco is a wine without MLT (previous screening). This wine will be enriched with 10 ng mL-1 MLT (MLT+) and used as experimental wine.

Group Type EXPERIMENTAL

Red wine with melatonin

Intervention Type OTHER

Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1)

Red wine without Melatonin

Rosso di Marco is a wine without MLT (previous screening). This wine will be used as placebo treatment (PLC).

Group Type PLACEBO_COMPARATOR

Red wine without melatonin

Intervention Type OTHER

Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT

Interventions

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Red wine with melatonin

Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1)

Intervention Type OTHER

Red wine without melatonin

Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* to be healthy
* to have normal weight (BMI 18.5-25.0)
* to voluntarily accept to participate to the study.

Exclusion Criteria

* pregnancy and lactation for women;
* supplementation with MLT and/or any other dietary supplement (vitamins, antioxidants, botanicals, phytochemicals)
* systemic and chronic-degenerative diseases
* abnormal hematological parameters
* heavy smoking and alcohol drinking
* high-intensity physical activity
* under pharmacological treatment

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes