Effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients

The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients.

This study is a double-blind, randomized controlled clinical trial with two parallel groups. 50 patients will be randomly assigned into isoflavone and control group.

Patients under peritoneal dialysis referring to the Shafa clinic and Dr. Najafi clinic will be invited to participate. After assessing the entrance criteria, 7 cc blood samples are taken. The food recall is completed. Supplements are given to patients for a month. For double-blind implementation, in the beginning, all boxes of supplements by a third party is coded as A and B

Inclusion criteria: At least 6 months have passed since the onset of Continuous Ambulatory Peritoneal Dialysis; Being in the age range of 18-75 years Exclusion criteria: Receiving isoflavones supplement

Patients in the isoflavone group will receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone. Patients in the control group will receive 2 tablets of placebo containing starch (Goldaru Company) per day.

Serum concentrations of lipoprotein-a; malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; Soluble vascular adhesion molecule-1; E-selectin; bone alkaline phosphatase; osteocalcin; N-telopeptide; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; albumin; calcium; phosphorous; blood nitrogen urea; creatinine

changes in some outcome variables

Patients on the basis of diabetes are categorized and are randomly assigned to the soy isoflavone or placebo group. To random allocation, a Stratified Blocked Randomization method is used. After specifying blocks of size 4 and allocating numbers to each block, a random number table is used to determine the treatment assignment list. Randomization is concealed in sequentially numbered, sealed, opaque envelope.

This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing soybean isoflavone or placebo by a third party (someone other than the researchers) is coded as A and B.