Clinical trial NCT02767102: Bioavailability and Bioactivity of Red Wine Melatonin in Humans
Official title: Serum and Salivary Melatonin Levels and Antioxidant Power of Melatonin-rich Red Wine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: Mediterranean diet
indoleamine
nutraceuticals
nutrition
oxidative stress
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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

Primary outcomes:
measure: Serum and salivary melatonin after red wine intake (with or without MLT)
timeFrame: 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:
measure: Antioxidant power of saliva and serum after red wine intake (with or without MLT)
timeFrame: 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:
measure: Adverse effects
timeFrame: Acute side effects during the trial recorded at each experimental day each experimental day, up to 1 day after
Locations:
city: Milano
country: Italy
facility: University of Milan
Study officials:
References: