Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029796
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2002-01-23
Brief Title:
Isoflavones and Acute-phase Response in Chronic Renal Failure
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Isoflavones and Acute-phase Response in Chronic Renal Failure
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 affecting positively clinically relevant parameters of disease activity in ESRD
The specific objective of this proposal is to conduct a randomized double-blinded dietary intervention trial in hemodialysis patients to determine whether
1 Dietary intake of the soy isoflavones by ESRD patients with clinical signs of ongoing acute-phase response decreases the production of the proinflammatory cytokines TNF-alpha IL-1 and IL-6 in peripheral blood thus changing the balance between these cytokines and their antagonists sTNF RI sTNF RII and IL-1ra
2 Suppression of inflammatory cytokine production by soy isoflavones is associated with improvement of clinically relevant parameters of disease activity including improvement of blood markers of acute-phase response and decreased blood levels of markers of metabolic bone disease
3 Intake of soy isoflavones suppresses NF-KB activity in peripheral blood monocytic cells of ESRD patients in a manner consistent with change of cytokine levels and of clinical parameters of disease
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 affecting positively clinically relevant parameters of disease activity in ESRD
The specific objective of this proposal is to conduct a randomized double-blinded dietary intervention trial in hemodialysis patients to determine whether
1 Dietary intake of the soy isoflavones by ESRD patients with clinical signs of ongoing acute-phase response decreases the production of the proinflammatory cytokines TNF-alpha IL-1 and IL-6 in peripheral blood thus changing the balance between these cytokines and their antagonists sTNF RI sTNF RII and IL-1ra
2 Suppression of inflammatory cytokine production by soy isoflavones is associated with improvement of clinically relevant parameters of disease activity including improvement of blood markers of acute-phase response and decreased blood levels of markers of metabolic bone disease
3 Intake of soy isoflavones suppresses NF-KB activity in peripheral blood monocytic cells of ESRD patients in a manner consistent with change of cytokine levels and of clinical parameters of disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None