Pilot Study to Evaluate the Plasma Profile of Revifast

NCT04258306 | Completed

• 1 other identifier: RVF01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nutrient; Excess; Product Use Issue

Keywords

Pharmacokinetics of resveratrol. Plasma profile of a new formulation based on resveratrol

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Dietary Supplement: pure resveratrol

REVIFAST

EXPERIMENTAL

180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold \& Zucc. Root supported on Magnesium hydroxide).

Dietary Supplement: Revifast

Interventions

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%).

REVIFAST

pure resveratrol DIETARY_SUPPLEMENT

resveratrol extracted from Polygonum cuspidatum resveratrol (98%).

Also known as: trans-resveratrol

Resveratrol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects naive to taking resveratrol, willing and able to understand and sign an informed consent;
• 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).

You may not qualify if:

• Chronic pathologies (chronic renal failure, chronic hepatocellular insufficiency, autoimmune diseases, chronic inflammatory bowel diseases, diabetes mellitus, end-stage neoplasms, symptomatic chronic ischemic heart disease);
• 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

Sponsors & Collaborators

• Bernard Fioretti: lead

Study Sites (1)

Deparment of Chemistry, Biology and Biotechnology

Perugia, PG, 06131, Italy

Location

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind, the subject, but not the responsible investigator, does not know which of the two possible treatments he receives.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of General Phisiology

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: October 1, 2017
• Primary Completion: November 20, 2017
• Study Completion: April 1, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)