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

U

University of Milan

Status

Completed

Conditions

Bioavailability

Treatments

Other: Red wine with melatonin
Other: Red wine without melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT02767102
Red Wine Melatonin

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups, including a placebo group

Red wine with Melatonin
Experimental group
Description:
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.
Treatment:
Other: Red wine with melatonin
Red wine without Melatonin
Placebo Comparator group
Description:
Rosso di Marco is a wine without MLT (previous screening). This wine will be used as placebo treatment (PLC).
Treatment:
Other: Red wine without melatonin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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