Bioavailability and Bioactivity of Red Wine Melatonin in Humans

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Serum and Salivary Melatonin Levels and Antioxidant Power of Melatonin-rich Red Wine

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Other: Red wine with melatonin
* Other: Red wine without melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red wine with Melatonin<br>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. | Other: Red wine with melatonin<br>* Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1)<br>|
| Placebo Comparator: Red wine without Melatonin<br>Rosso di Marco is a wine without MLT (previous screening). This wine will be used as placebo treatment (PLC). | Other: Red wine without melatonin<br>* Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and salivary melatonin after red wine intake (with or without MLT) | LC-MS analyses for serum and ELISA analyses for saliva | Time-course of the serum melatonin levels in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary melatonin levels in healthy volunteer from 0 min to 120 min after administration of red wine. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant power of saliva and serum after red wine intake (with or without MLT) | FRAP analyses | Time-course of the serum antioxidant power in healthy volunteer from 0 min to 90 min after administration of red wine. Time-course of the salivary antioxidant power in healthy volunteer from 0 min to 120 min after administration of red wine. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mediterranean diet, indoleamine, nutraceuticals, nutrition, oxidative stress