Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-01-04 @ 8:39 AM
Study NCT ID:
NCT02767102
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2016-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability and Bioactivity of Red Wine Melatonin in Humans
Sponsor:
University of Milan
Organization:
Study Overview
Official Title:
Serum and Salivary Melatonin Levels and Antioxidant Power of Melatonin-rich Red Wine
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Wine-MLT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: