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

• Published in: Pharmaceutical research Vol. 27; no. 6; pp. 1061 - 1065
• Main Authors: Dominiak, Kristin, McKinney, Jaclyn, Heilbrun, Lance K, Sarkar, Fazlul H
• Format: Journal Article
• Language: English
• Published: United States 01.06.2010
• Subjects: 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; Neoplasms - prevention & control; NF-kappa B - immunology; NF-kappa B - metabolism; Oxidative Stress - drug effects; Tumor Necrosis Factor-alpha - immunology; Young Adult
• ISSN: 1573-904X
• DOI: 10.1007/s11095-010-0113-y

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.