Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peritoneal Dialysis Patients
- Sponsor
- National Nutrition and Food Technology Institute
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Lp (a)
- Last Updated
- 6 years ago
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
Investigators
zahra yari
Principal Investigator
National Nutrition and Food Technology Institute
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
Outcomes
Primary Outcomes
Lp (a)
Time Frame: 8 weeks
Serum concentrations of lipoprotein-a
triglyceride
Time Frame: 8 weeks
Serum concentrations of triglyceride
Osteoprotegerin
Time Frame: 8 weeks
Serum concentrations of Osteoprotegerin
RANKL
Time Frame: 8 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
osteocalcin
Time Frame: 8 weeks
Serum concentrations of osteocalcin
N-telopeptide
Time Frame: 8 weeks
Serum concentrations of N-telopeptide
hs-CRP
Time Frame: 8 weeks
Serum concentrations of high sensitivity c-reactive protein
MDA
Time Frame: 8 weeks
Serum concentrations of malondialdehyde
sICAM-1
Time Frame: 8 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
bone alkaline phosphatase
Time Frame: 8 weeks
Serum concentrations of bone alkaline phosphatase
total cholesterol
Time Frame: 8 weeks
Serum concentrations of total cholesterol
HDL-C
Time Frame: 8 weeks
Serum concentrations of High-density lipoprotein cholesterol
LDL-C
Time Frame: 8 weeks
Serum concentrations of low-density lipoprotein cholesterol
sVCAM-1
Time Frame: 8 weeks
Serum concentrations of Soluble vascular adhesion molecule-1
E-selectin
Time Frame: 8 weeks
Serum concentrations of E-selectin
Secondary Outcomes
- calcium(8 weeks)
- albumin(8 weeks)
- phosphorous(8 weeks)
- iPTH(8 weeks)