Chronic Subclinic InflammationPhase 3NCT01492114
Anti-inflammatory and Antioxidant Effects of Resveratrol on Healthy Adults.
A Phase 3 study testing Resveratrol in people with Chronic Subclinic Inflammation and Redox Status, run by University of Turin, Italy at 1 site in Italy.
Trial summary
This research will investigate the hypothesis that resveratrol when given orally to healthy adult smokers induces a decrease in the inflammatory and oxidative mediators which characterize the low-grade systemic inflammatory state and the oxidants-antioxidants imbalance of tobacco users. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Subclinic Inflammation, Redox Status
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Mar 2012
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20-50 years
- actual smoking (≥5 cigarettes/die)
- mean alcohol consumption <30g/day
- absence of known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions -no use of any drug -oestrogen excluded-
- not being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the least 6-months
Who cannot join
- actual pregnancy -known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic chronic or acute conditions, use of any drug -oestrogen excluded-
- being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the last six months
- mean alcohol consumption ≥30g/day
- body mass index (BMI)>30 kg/m2
- subject unable to give his/her informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Cross-over Randomised Controlled Trial on the Anti-inflammatory and Antioxidant Effects of Resveratrol on Healthy Adults.
This research will investigate the hypothesis that resveratrol when given orally to healthy adult smokers induces a decrease in the inflammatory and oxidative mediators which characterize the low-grade systemic inflammatory state and the oxidants-antioxidants imbalance of tobacco users.
Read the detailed description
The effect of resveratrol in humans is still not well defined. The number of studies on resveratrol has increased extraordinarily since 1997, when its anticancer effect has been reported. However, most of these studies are in-vitro or animal studies. Preclinical observations in humans suggest that resveratrol is safe and has potential in the treatment of obesity and insulin resistance in humans.
In particular, it improves insulin sensitivity, which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway. Studies on toxicity of resveratrol in humans demonstrated that this compound is well tolerated and no adverse effect has been found with higher dosage (5g/day). Resveratrol is available to people over-the-counter in health food stores and the internet as a dietary supplement. In humans, resveratrol is efficiently absorbed after oral administration; however, rapid phase II metabolism drastically limits its plasma bio-availability. The high concentrations of resveratrol in colorectal tissues, in excess of that required for activity in vitro, supports the colon as a target organ. The efficacy of resveratrol in other tissues may be largely dependent on whether its metabolites have significant activity or are able to regenerate resveratrol either locally or systemically (e.g. some metabolites, mainly sulfate-conjugated resveratrol, show biological effects in cellular models).
There are only a few studies evaluating the anti-inflammatory properties of resveratrol in humans. An extract of Polygonum Cuspidatum containing resveratrol given for 6-weeks to 10 healthy subjects was able to significantly suppress plasma concentrations of inflammatory cytokines (C-reactive protein, interleukin-6, tumor necrosis factor-α). Similarly, a nutritional supplement containing resveratrol plays an acute antioxidant and antiinflammatory effects in the postprandial state after a high-fat, high-carbohydrate meal in 10 healthy females.
The anti-inflammatory and antioxidant effects of resveratrol may be particularly interesting for smokers. Resveratrol increases the NO bioavailability and the inhibition of cyclooxygenase and 5-lipoxygenase activity of Cox-1 and it prevents the vascular leucocyte migration into damaged organs by decreasing the expression of endothelial vascular adhesion molecules and of pro-inflammatory genes. The inflammatory responses induced by oxidized LDL (low-density lipoproteins) are partially avoided by the addition of reveratrol and the authors concluded that it could affect vascular inflammation or/and injury not only as antioxidant, but also as modulator of inflammatory redox signalling pathways.
However, there are currently no published demonstrations of therapeutic or protective effects of resveratrol in appropriately designed clinical trials.
- Conditions
- Chronic Subclinic Inflammation, Redox Status
- Being tested
- Resveratrol
- Keywords
- C-reactive protein, Resveratrol, Redox index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Subjects in the group "resvetarol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting).
resveratrolDietary supplement
Subjects in the group "Placebo first" will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting).
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol first | Experimental | Subjects in the group "resveratrol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting). Receives: Dietary Supplement: Resveratrol |
| Placebo first | Active comparator | Subjects in the group "Placebo first" will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting). Receives: Dietary Supplement: resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
To evaluate before-after changes in circulating concentrations of C-reactive protein (CRP), an inflammation marker, in smokers submitted to resveratrol supplementation when compared to smokers treated with placebo
Measured: At baseline and every 30 days for three months
Secondary outcomes (9)
TAS (total antioxidant status)
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: TAS (total antioxidant status.
Measured: At baseline and every 30-days for three months
4-hydroxynonenal
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: 4-hydroxynonenal
Measured: At baseline and after 30-days for three months
nitrotyrosine
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: nitrotyrosine.
Measured: At baseline and every 30-days for three months
endothelial nitric oxide synthase (eNOS)-polymorphism
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: endothelial nitric oxide synthase (eNOS)-polymorphism
Measured: At baseline and every 30-days for three months
superoxide dismutase (SOD2)-polymorphism
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: superoxide dismutase (SOD2)-polymorphism.
Measured: At baseline and every 30-days for three months
catalase-polymorphism
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-markers of oxidative stress: catalase-polymorphism
Measured: At baseline and every 30-days for three months
interleukin-6
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-other markers of inflammation: interleukin-6.
Measured: At baseline and every 30-days for three months
pentraxin 3
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-other markers of inflammation: pentraxin 3.
Measured: At baseline and every 30-days for three months
tumor necrosis factor-α
To evaluate before-after changes in circulating fasting concentrations of the following parameters:
-other markers of inflammation: tumor necrosis factor-α.
Measured: At baseline and every 30-days for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subclinic InflammationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Bo, University of Turin, Italy
- Investigators
- Simona Bo, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492114
- Sponsor's protocol ID
- sbo2011
- Status last verified
- Jul 2012
- First submitted
- 12 Dec 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Cross-over Randomised Controlled Trial on the Anti-inflammatory and Antioxidant Effects of Resveratrol on Healthy Adults.
- ClinicalTrials.gov ID
- NCT01492114
- Acronym / sponsor ID
- sbo2011
- Conditions
- Chronic Subclinic Inflammation, Redox Status
- Keywords
- C-reactive protein, Resveratrol, Redox index
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- 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.
This research will investigate the hypothesis that resveratrol when given orally to healthy adult smokers induces a decrease in the inflammatory and oxidative mediators which characterize the low-grade systemic inflammatory state and the oxidants-antioxidants imbalance of tobacco users.
Detailed description
The effect of resveratrol in humans is still not well defined. The number of studies on resveratrol has increased extraordinarily since 1997, when its anticancer effect has been reported. However, most of these studies are in-vitro or animal studies. Preclinical observations in humans suggest that resveratrol is safe and has potential in the treatment of obesity and insulin resistance in humans.
In particular, it improves insulin sensitivity, which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway. Studies on toxicity of resveratrol in humans demonstrated that this compound is well tolerated and no adverse effect has been found with higher dosage (5g/day). Resveratrol is available to people over-the-counter in health food stores and the internet as a dietary supplement. In humans, resveratrol is efficiently absorbed after oral administration; however, rapid phase II metabolism drastically limits its plasma bio-availability. The high concentrations of resveratrol in colorectal tissues, in excess of that required for activity in vitro, supports the colon as a target organ. The efficacy of resveratrol in other tissues may be largely dependent on whether its metabolites have significant activity or are able to regenerate resveratrol either locally or systemically (e.g. some metabolites, mainly sulfate-conjugated resveratrol, show biological effects in cellular models).
There are only a few studies evaluating the anti-inflammatory properties of resveratrol in humans. An extract of Polygonum Cuspidatum containing resveratrol given for 6-weeks to 10 healthy subjects was able to significantly suppress plasma concentrations of inflammatory cytokines (C-reactive protein, interleukin-6, tumor necrosis factor-α). Similarly, a nutritional supplement containing resveratrol plays an acute antioxidant and antiinflammatory effects in the postprandial state after a high-fat, high-carbohydrate meal in 10 healthy females.
The anti-inflammatory and antioxidant effects of resveratrol may be particularly interesting for smokers. Resveratrol increases the NO bioavailability and the inhibition of cyclooxygenase and 5-lipoxygenase activity of Cox-1 and it prevents the vascular leucocyte migration into damaged organs by decreasing the expression of endothelial vascular adhesion molecules and of pro-inflammatory genes. The inflammatory responses induced by oxidized LDL (low-density lipoproteins) are partially avoided by the addition of reveratrol and the authors concluded that it could affect vascular inflammation or/and injury not only as antioxidant, but also as modulator of inflammatory redox signalling pathways.
However, there are currently no published demonstrations of therapeutic or protective effects of resveratrol in appropriately designed clinical trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol first | Experimental | Dietary Supplement: ResveratrolSubjects in the group "resveratrol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting). |
| Placebo first | Active comparator | Dietary Supplement: resveratrolSubjects in the group "Placebo first" will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 20-50 years
- actual smoking (≥5 cigarettes/die)
- mean alcohol consumption <30g/day
- absence of known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic conditions -no use of any drug -oestrogen excluded-
- not being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the least 6-months
Key exclusion criteria (5 listed)
- actual pregnancy -known hyperglycaemia, hypertension, cardiovascular disease, impaired renal function, liver disease, or any other systemic chronic or acute conditions, use of any drug -oestrogen excluded-
- being on a particular diet and/or vitamin or other nutrient or integrator supplementation during the last six months
- mean alcohol consumption ≥30g/day
- body mass index (BMI)>30 kg/m2
- subject unable to give his/her informed consent.
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 |
|---|---|---|
| ResveratrolSubjects in the group "resvetarol first" will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting). | Dietary supplement | Resveratrol first |
| resveratrolSubjects in the group "Placebo first" will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting). | Dietary supplement | Placebo first |
Primary outcome
C-reactive protein
Time frame: At baseline and every 30 days for three months
To evaluate before-after changes in circulating concentrations of C-reactive protein (CRP), an inflammation marker, in smokers submitted to resveratrol supplementation when compared to smokers treated with placebo
9 secondary outcomes
TAS (total antioxidant status)
Time frame: At baseline and every 30-days for three months
4-hydroxynonenal
Time frame: At baseline and after 30-days for three months
nitrotyrosine
Time frame: At baseline and every 30-days for three months
endothelial nitric oxide synthase (eNOS)-polymorphism
Time frame: At baseline and every 30-days for three months
superoxide dismutase (SOD2)-polymorphism
Time frame: At baseline and every 30-days for three months
catalase-polymorphism
Time frame: At baseline and every 30-days for three months
interleukin-6
Time frame: At baseline and every 30-days for three months
pentraxin 3
Time frame: At baseline and every 30-days for three months
tumor necrosis factor-α
Time frame: At baseline and every 30-days for three months
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 10 Jul 2012.
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.
Simona Bo, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resveratrol in people with Chronic Subclinic Inflammation and Redox Status, run by University of Turin, Italy 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 5 inclusion and 5 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 10 Jul 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
C-reactive protein (time frame: At baseline and every 30 days for three months). 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 10 Jul 2012.