title: 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.
abstract: 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.
authors.affiliation: Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan, USA.
authors.forename: Kristin
authors.initials: K
authors.lastname: Dominiak
authors.forename: Jaclyn
authors.initials: J
authors.lastname: McKinney
authors.forename: Lance K
authors.initials: LK
authors.lastname: Heilbrun
authors.forename: Fazlul H
authors.initials: FH
authors.lastname: Sarkar
mesh_terms: D000328:Adult; D001688:Biological Products / Q000494:pharmacology / Q000627:therapeutic use*; D002392:Catechin / Q000031:analogs & derivatives / Q000627:therapeutic use; D003474:Curcumin / Q000627:therapeutic use; D004247:DNA / Q000378:metabolism; D005260:Female; D006801:Humans; D007529:Isoflavones / Q000627:therapeutic use; D008214:Lymphocytes / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D016328:NF-kappa B / Q000276:immunology* / Q000378:metabolism; D009369:Neoplasms / Q000517:prevention & control; D018384:Oxidative Stress / Q000187:drug effects*; D014409:Tumor Necrosis Factor-alpha / Q000276:immunology*; D055815:Young Adult
chemical_list: D001688:Biological Products; D007529:Isoflavones; D016328:NF-kappa B; D014409:Tumor Necrosis Factor-alpha; D002392:Catechin; D004247:DNA; C045651:epigallocatechin gallate; D003474:Curcumin