Bioavailability and Bioactivity of Red Wine Melatonin in Humans

NCT02767102 | Completed

• 1 other identifier: Red Wine Melatonin
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

Mediterranean diet; indoleamine; nutraceuticals; nutrition; oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Antioxidant power of saliva and serum after red wine intake (with or without MLT)

  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 Outcomes (1)

• Adverse effects

  Acute side effects during the trial recorded at each experimental day each experimental day, up to 1 day after

Study Arms (2)

Red wine with Melatonin

EXPERIMENTAL

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

Red wine without Melatonin

PLACEBO COMPARATOR

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

Other: Red wine without melatonin

Interventions

Red wine with melatonin OTHER

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

Red wine with Melatonin

Red wine without melatonin OTHER

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

Red wine without Melatonin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

University of Milan

Milan, Italy, 20142, Italy

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 10, 2016
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 10, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)