Bioavailability and Bioactivity of Red Wine Melatonin in Humans (Wine-MLT)

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

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Other: Red wine with melatonin; Other: Red wine without melatonin

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20142
    • University of Milan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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)
Placebo Comparator: Red wine without Melatonin; Rosso di Marco is a wine without MLT (previous screening). This wine will be used as placebo treatment (PLC).	Other: Red wine without melatonin; Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Questionnaire	Acute side effects during the trial recorded at each experimental day each experimental day, up to 1 day after

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 30, 2016
• First Submitted That Met QC Criteria: May 5, 2016
• First Posted (Estimate): May 10, 2016

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: nutrition; oxidative stress; nutraceuticals; Mediterranean diet; indoleamine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: Red Wine Melatonin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No