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The purpose of this study is to evaluate in 6 subjects aged between 18 and 60 years the peak blood (plasma profile) of two formulations, indistinguishable from each other, containing:
A) 180 mg natural Resveratrol (Polygonum cuspidatum 98%) B) 180 mg of Revifast® (resveratrol from supported on Magnesium hydroxide).
The study will be randomized, controlled, single blind, cross-over, using the two granular compounds in capsules A and B, indistinguishable from each other, dissolved in aqueous solution and administered orally. either A:180 mg natural Resveratrol (Polygonum cuspidatum 98%) deriving from galenic preparation from the IRRE pharmacy - Istituto Riuniti based in Cannara in via Vittorio Emanuele II 23.
B) 180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold & Zucc. Root supported on Magnesium hydroxide).
Cross-over refers to a type of clinical study in which each individual receives each of the treatments consecutively.
PHASE I: The subjects will be given, on the first day, in the morning on an empty stomach, a solution of content A or B obtained by dissolving the contents of the capsule in water which will then be taken orally. Samples of 2 ml of venous blood in a tube containing EDTA will be taken from a vein in the arm using a cannula at 0 min (fasting before administration), 15 min, 30 min, 60 min, 90 min, 120 min, 180 min .
WASH-OUT: 1 day. PHASE II: On the third day, the person who had taken the solution A will take the solution B, and vice versa, with the same methods and times described above.
The study will have a total duration of 6 weeks divided as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Active Comparator | 180 mg natural Resveratrol (Polygonum cuspidatum 98%) deriving from galenic preparation from the IRRE pharmacy - Istituto Riuniti based in Cannara in via Vittorio Emanuele II 23. |
|
| REVIFAST | Experimental | 180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold & Zucc. Root supported on Magnesium hydroxide). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revifast | Dietary Supplement | Revifast® is based on natural resveratrol supported on Magnesium hydroxide. Revifast® particles confer an improved dissolution rate in tests that mimic the gastric environment compared to Polygonum cuspidatum resveratrol (98%). |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the plasma concentration (micromolar concentration) of free resveratrol after administration of a tablet containing 150mg of resveratrol in either the Resv@MDH form or pure resveratrol dissolved in water. | Analysis of the peak plasmatic profile of resveratrol in venous blood samples at specific time intervals and after administration of a tablet dissolved in water of two different formulations based on resveratrol. Timing of blood samples: (fasting before administration), 15 min, 30 min, 60 min, 90 min, 120 min, 180 min after oral administration. Samples of blood will be analyzed for pharmacological and metabolomic analysis of resveratrol and evaluate the concentration of resveratrol (micro molar) using a mass spectrometer. | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Chemistry, Biology and Biotechnology | Perugia | PG | 06131 | Italy |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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The subjects will be given, on the first day, in the morning on an empty stomach, a solution of content A or B obtained by dissolving the contents of the capsule in water which will then be taken orally. Samples of 2 ml of venous blood in a tube containing EDTA will be taken from a vein in the arm using a cannula at 0 min (fasting before administration), 15 min, 30 min, 60 min, 90 min, 120 min, 180 min. WASH-OUT on the second day. On the third day, the person who had taken the solution A will take the solution B, and vice versa, with the same methods and times described above.
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Single blind, the subject, but not the responsible investigator, does not know which of the two possible treatments he receives.
| pure resveratrol | Dietary Supplement | resveratrol extracted from Polygonum cuspidatum resveratrol (98%). |
|
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |