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Completed

NCT Number: NCT02767102

Bioavailability and Bioactivity of Red Wine Melatonin in Humans

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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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Milan

Milan, Italy, 20142

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 without melatonin

Other

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

Primary outcomes

  1. Serum and salivary melatonin after red wine intake (with or without MLT)

    Time frame: 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.

    LC-MS analyses for serum and ELISA analyses for saliva

Secondary outcomes

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

    Time frame: 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.

    FRAP analyses

Other outcomes

  1. Adverse effects

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

    Questionnaire

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Acronym: Wine-MLT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 10, 2016
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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