Isoflavones and Acute-phase Response in Chronic Renal Failure

• Status: Completed
• Trial end date: 2003-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion criteria:

• Initiation of chronic hemodialysis therapy more than 6 months prior to enrollment in the study.

• Routine dialysis with highly biocompatible dialysis membranes, including polysulfone, polycarbonate, polyamide, or polymethylmethacrylate membranes.

• Historical compliance with three times weekly routine hemodialysis therapy.

• Ability and willingness to adhere to the intake of soy protein isolate drinks during dialysis therapy.

Exclusion criteria:

• Use of calcitriol within the last six weeks

• Acute illness known to cause acute-phase response, including clinically detectable infections, trauma, surgery, burns, and tissue infarction, within the last 6 weeks.

• Chronic conditions known to cause acute-phase response, including immunologically-mediated and crystal-induced illnesses, cancer, and psychiatric illnesses.

• Hematocrit below 30%

• Aluminum intoxication

• Smoking

• Gastrointestinal disturbances that can interfere with isoflavone absorption, including acute gastrointestinal illness and/or intestinal microflora depletion following use of antibiotics within the last three months, chronic malabsorption syndrome, chronic liver disease.

• Other significant medical illnesses including decompensated heart failure, unstable coronary artery disease, advanced chronic obstructive pulmonary disease, decompensated thyroid disease, alcoholism, substance abuse.