Anti-inflammatory and Antioxidant Effects of Resveratrol on Healthy Adults.
Condition: Chronic Subclinic Inflammation; Redox Status
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): Resveratrol; resveratrol
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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).; 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).
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: C-reactive protein; Resveratrol; Redox index