Clinical Trial: Isoflavones and Acute-phase Response in Chronic Renal Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Isoflavones and Acute-phase Response in Chronic Renal Failure

Brief Summary: This is a randomized, double-blinded dietary intervention in hemodialysis patients to determine the clinical and metabolic effects of soy isoflavones on disease activity, including improvement of blood markers of acute-phase response, and decreased blood levels of markers of metabolic bone disease.

Detailed Summary:

Up to 40 percent of end stage renal disease (ESRD) patients suffer from a chronic inflammatory process which is not currently amenable to specific treatment and is associated with high morbidity and mortality. High circulating levels and production of pro-inflammatory cytokines are an essential part of this ongoing acute-phase response and they are believed to exacerbate many of the clinical manifestations of ESRD, including renal osteodystrophy. Like in all other inflammatory processes that have undergone more extensive investigation, the nuclear factor, Nuclear Factor Kappa-B (NFKB) promises to be a critical cellular intermediate of this acute-phase response and to be both mediator and target of inflammatory cytokine effects. In the current search for agents that may be able to negate the ongoing acute-phase response of ESRD, the soy isoflavones genistein and daidzein have emerged as potentially useful. These isoflavones are present in many soyfoods, are available as over-the-counter nutritional supplements and have received growing attention due to their biological properties and potential as therapeutic agents. Inhibitory effects of the isoflavones on tyrosine kinase and NFKB activity, on inflammatory cytokine production and on oxidative stress have been demonstrated by this group and by many other investigators and they may be highly relevant to the renal failure population. Additionally, we have found recently that intake of soy food by ESRD patients results in very high blood levels of isoflavones and it is well tolerated.

It is our working hypothesis that in chronic renal failure a variety of endogenous and exogenous factors trigger acute-phase response with activation of NFKB and production of pro-inflammatory cytokines, and that intervention with soy isoflavones inhibits NFKB activation and cytokines production, thus blocking the ongoing acute-phase response and
Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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Information By: National Center for Complementary and Integrative Health (NCCIH)

Dates:
Date Received: January 23, 2002
Date Started:
Date Completion:
Last Updated: March 21, 2013
Last Verified: March 2013