Pilot Study to Evaluate the Plasma Profile of Revifast
Condition: Nutrient; Excess; Product Use Issue
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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:

        -  Pre-monitoring phase, enrollment of subjects, random assignment in two arms 1 and 2 each
           consisting of 3 subjects and signature of the informative consent regarding the adhesion
           to the study protocol (1 week);

        -  1 week for taking samples and storing them for routine chemical / biochemical analyzes
           carried out at the Crabion S.R.L. accredited center based in Corciano in via Amilcare
           Ponchielli 8 (on the first day, arm 1 will start treatment with solution A; on the
           second day, this arm will wash-out and arm 2 will start treatment with solution A; on
           third day on arm 1 will start the treatment with solution B and arm 2 will wash-out; on
           the fourth day arm 2 will carry out the treatment with solution B; once the routine
           analyzes have been carried out, on the fifth day the frozen samples will be sent to the
           Department of chemistry, biology and biotechnology of the University of Perugia for
           subsequent extraroutine analyzes).

        -  2 weeks for carrying out the pharmacological and metabolomic analyzes of extraroutins
           performed at the Department of chemistry, biology and biotechnology of the University of
           Perugia;

        -  2 weeks for carrying out statistical tests and processing the data obtained.
    

Intervention name(s): Revifast; pure resveratrol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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%).; resveratrol extracted from Polygonum cuspidatum resveratrol (98%).
Other intervention name(s): trans-resveratrol
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Pharmacokinetics of resveratrol. Plasma profile of a new formulation based on resveratrol