Nutrient; ExcessNCT04258306
Pilot Study to Evaluate the Plasma Profile of Revifast
A study testing Revifast and pure resveratrol in people with Nutrient; Excess and Product Use Issue, run by Bernard Fioretti at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrient; Excess, Product Use Issue
- What is being tested?
- Revifast and pure resveratrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- Poor compliance;
- Taking dietary supplements containing antioxidants;
- Untreated hypothyroidism;
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
Italy1 site
Deparment of Chemistry, Biology and Biotechnology
Perugia, PG, 06131
About this study
Official title: Randomized, Single-blind, Cross-over Pilot Study to Evaluate the Plasma Profile of Resveratrol Following an Oral Administration of Either Revifast® (Resveratrol From Polygonum Cuspidatum Extract Siebold & Zucc - Root Supported on Magnesium Hydration With a Weight Titer of Min. 30% Resveratrol) and Unsupported Pure Resveratrol
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:
- 180 mg natural Resveratrol (Polygonum cuspidatum 98%) B) 180 mg of Revifast® (resveratrol from supported on Magnesium hydroxide).
Read the 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.
- 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
- Nutrient; Excess, Product Use Issue
- Being tested
- Revifast, pure resveratrol
- Keywords
- Pharmacokinetics of resveratrol. Plasma profile of a new formulation based on resveratrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevifastDietary 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%).
pure resveratrolDietary supplement
Also called trans-resveratrol
resveratrol extracted from Polygonum cuspidatum resveratrol (98%).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: pure resveratrol |
| REVIFAST | Experimental | 180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold \& Zucc. Root supported on Magnesium hydroxide). Receives: Dietary Supplement: Revifast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Oct 2017
- Primary completion20 Nov 2017
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient; ExcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernard Fioretti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernard Fioretti, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258306
- Sponsor's protocol ID
- RVF01
- Status last verified
- Apr 2020
- First submitted
- 31 Jan 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blind, Cross-over Pilot Study to Evaluate the Plasma Profile of Resveratrol Following an Oral Administration of Either Revifast® (Resveratrol From Polygonum Cuspidatum Extract Siebold & Zucc - Root Supported on Magnesium Hydration With a Weight Titer of Min. 30% Resveratrol) and Unsupported Pure Resveratrol
- ClinicalTrials.gov ID
- NCT04258306
- Acronym / sponsor ID
- RVF01
- Conditions
- Nutrient; Excess, Product Use Issue
- Keywords
- Pharmacokinetics of resveratrol. Plasma profile of a new formulation based on resveratrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bernard FiorettiUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Dietary Supplement: pure resveratrol180 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 | Dietary Supplement: Revifast180 mg of Revifast® (mixture of resveratrol from Polygonum cuspidatum extract Siebold \& Zucc. Root supported on Magnesium hydroxide). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RevifastRevifast® 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%). | Dietary supplement | REVIFAST |
| pure resveratrolAlso: trans-resveratrolresveratrol extracted from Polygonum cuspidatum resveratrol (98%). | Dietary supplement | Resveratrol |
Primary outcome
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.
Time frame: 2 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revifast and pure resveratrol in people with Nutrient; Excess and Product Use Issue, run by Bernard Fioretti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.