Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2017-10-01
2019-04-01
Brief Summary
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A) 180 mg natural Resveratrol (Polygonum cuspidatum 98%) B) 180 mg of Revifast® (resveratrol from supported on Magnesium hydroxide).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Resveratrol
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.
pure resveratrol
resveratrol extracted from Polygonum cuspidatum resveratrol (98%).
REVIFAST
180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold \& Zucc. Root supported on Magnesium hydroxide).
Revifast
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%).
Interventions
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Revifast
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%).
pure resveratrol
resveratrol extracted from Polygonum cuspidatum resveratrol (98%).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal blood and chemical tests: blood count, lipid structure, kidney and liver function, inflammatory structure (Tnfα, reactive protein C, ESR), glycemic profile (Fasting blood glucose, HbA1C, insulinemia, Homa Index).
Exclusion Criteria
* severe arterial hypertension;
* High degree hypercholesterolaemia;
* Up to two previous days' intake of red wine not exceeding 2 glasses / day for men and 1 glass / day for women;
* Up to two previous days intake of foods containing resveratrol (red grapes, blueberries, dried fruit);
* Age \<18 years;
* Poor compliance;
* Taking dietary supplements containing antioxidants;
* Untreated hypothyroidism;
* Pregnant and breastfeeding women
18 Years
60 Years
MALE
Yes
Sponsors
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Bernard Fioretti
OTHER
Responsible Party
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Bernard Fioretti
Associate Professor of General Phisiology
Locations
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Deparment of Chemistry, Biology and Biotechnology
Perugia, PG, Italy
Countries
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Other Identifiers
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RVF01
Identifier Type: -
Identifier Source: org_study_id
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