Pharmaceutical Research

, Volume 27, Issue 6, pp 1061–1065 | Cite as

Critical Need for Clinical Trials: An Example of a Pilot Human Intervention Trial of a Mixture of Natural Agents Protecting Lymphocytes Against TNF-α Induced Activation of NF-κB

  • Kristin Dominiak
  • Jaclyn McKinney
  • Lance K. Heilbrun
  • Fazlul H. Sarkar


Humans typically consume “natural agents” that are believed to be chemoprotective and are known to decrease inflammation biomarker NF-κB 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-α or kept as untreated control. The mean NF-κB DNA binding activity was increased upon TNF-α treatment in pre-intervention samples; however, TNF-α was unable to induce NF-κB in post-intervention samples, suggesting that the mixture of four important natural agents could be useful to protect humans against oxidative stress.


curcumin epigallocatechin-3-gallate (EGCG) isoflavone NF-κB TNF-α resveratrol 



There is no potential conflict of interest.


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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Kristin Dominiak
    • 2
  • Jaclyn McKinney
    • 2
  • Lance K. Heilbrun
    • 1
  • Fazlul H. Sarkar
    • 2
    • 3
  1. 1.Department of Internal MedicineWayne State University School of MedicineDetroitUSA
  2. 2.Karmanos Cancer InstituteWayne State University School of MedicineDetroitUSA
  3. 3.Department of Pathology, Barbara Ann Karmanos Cancer InstituteWayne State University School of MedicineDetroitUSA

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