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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
100 mg soy isoflavone (as 2 capsules)
2 capsules of placebo
National Nutrition and Food Technology Research Institute
Tehran, Iran (the Islamic Republic Of), Iran
RECRUITINGLp (a)
Serum concentrations of lipoprotein-a
Time frame: 8 weeks
MDA
Serum concentrations of malondialdehyde
Time frame: 8 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Time frame: 8 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Time frame: 8 weeks
bone alkaline phosphatase
Serum concentrations of bone alkaline phosphatase
Time frame: 8 weeks
osteocalcin
Serum concentrations of osteocalcin
Time frame: 8 weeks
N-telopeptide
Serum concentrations of N-telopeptide
Time frame: 8 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Time frame: 8 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Time frame: 8 weeks
triglyceride
Serum concentrations of triglyceride
Time frame: 8 weeks
total cholesterol
Serum concentrations of total cholesterol
Time frame: 8 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Time frame: 8 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Time frame: 8 weeks
sVCAM-1
Serum concentrations of Soluble vascular adhesion molecule-1
Time frame: 8 weeks
E-selectin
Serum concentrations of E-selectin
Time frame: 8 weeks
albumin
Serum concentrations of albumin
Time frame: 8 weeks
calcium
Serum concentrations of calcium
Time frame: 8 weeks
phosphorous
Serum concentrations of phosphorous
Time frame: 8 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Time frame: 8 weeks
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