Critical need for clinical trials: an example of a pilot human intervention trial of a mixture of natural agents protecting lymphocytes against TNF-alpha induced activation of NF-kappaB

Pharm Res. 2010 Jun;27(6):1061-5. doi: 10.1007/s11095-010-0113-y. Epub 2010 Apr 6.


Humans typically consume "natural agents" that are believed to be chemoprotective and are known to decrease inflammation biomarker NF-kappaB in vitro; however, no intervention studies in humans have been done to date. This commentary documents the in vivo results as a powerful example for supporting the superiority of a complex mixture of natural agents. Human volunteers consumed two 500 mg capsules (BID) containing a mixture of natural agents for a period of 2 weeks, and blood samples were collected pre- and post-intervention. The purified lymphocytes were subjected to ex-vivo exposure to TNF-alpha or kept as untreated control. The mean NF-kappaB DNA binding activity was increased upon TNF-alpha treatment in pre-intervention samples; however, TNF-alpha was unable to induce NF-kappaB in post-intervention samples, suggesting that the mixture of four important natural agents could be useful to protect humans against oxidative stress.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Biological Products / pharmacology
  • Biological Products / therapeutic use*
  • Catechin / analogs & derivatives
  • Catechin / therapeutic use
  • Curcumin / therapeutic use
  • DNA / metabolism
  • Female
  • Humans
  • Isoflavones / therapeutic use
  • Lymphocytes / drug effects*
  • Male
  • Middle Aged
  • NF-kappa B / immunology*
  • NF-kappa B / metabolism
  • Neoplasms / prevention & control
  • Oxidative Stress / drug effects*
  • Tumor Necrosis Factor-alpha / immunology*
  • Young Adult


  • Biological Products
  • Isoflavones
  • NF-kappa B
  • Tumor Necrosis Factor-alpha
  • Catechin
  • DNA
  • epigallocatechin gallate
  • Curcumin