The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing

Official Title
-----------------
Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients

Conditions
-----------------
Peritoneal Dialysis Patients

Intervention / Treatment
-----------------
* Dietary Supplement: soy isoflavone
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35 Exclusion Criteria: infections inflammatory diseases; liver diseases; past medical history of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: isoflavone<br>100 mg soy isoflavone (as 2 capsules) | Dietary Supplement: soy isoflavone<br>* 100 mg soy isoflavone (as 2 capsules)<br>|
| Placebo Comparator: control<br>2 capsules of placebo | Other: placebo<br>* 2 capsules of placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lp (a) | Serum concentrations of lipoprotein-a | 8 weeks | 
| MDA | Serum concentrations of malondialdehyde | 8 weeks | 
| hs-CRP | Serum concentrations of high sensitivity c-reactive protein | 8 weeks | 
| sICAM-1 | Serum concentrations of Soluble intercellular adhesion molecule-1 | 8 weeks | 
| bone alkaline phosphatase | Serum concentrations of bone alkaline phosphatase | 8 weeks | 
| osteocalcin | Serum concentrations of osteocalcin | 8 weeks | 
| N-telopeptide | Serum concentrations of N-telopeptide | 8 weeks | 
| Osteoprotegerin | Serum concentrations of Osteoprotegerin | 8 weeks | 
| RANKL | Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand | 8 weeks | 
| triglyceride | Serum concentrations of triglyceride | 8 weeks | 
| total cholesterol | Serum concentrations of total cholesterol | 8 weeks | 
| HDL-C | Serum concentrations of High-density lipoprotein cholesterol | 8 weeks | 
| LDL-C | Serum concentrations of low-density lipoprotein cholesterol | 8 weeks | 
| sVCAM-1 | Serum concentrations of Soluble vascular adhesion molecule-1 | 8 weeks | 
| E-selectin | Serum concentrations of E-selectin | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albumin | Serum concentrations of albumin | 8 weeks | 
| calcium | Serum concentrations of calcium | 8 weeks | 
| phosphorous | Serum concentrations of phosphorous | 8 weeks | 
| iPTH | Serum concentrations of Intact parathyroid hormone | 8 weeks |