NCT03773029

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peritoneal Dialysis Patients

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	soy isoflavone	100 mg soy isoflavone (as 2 capsules)
OTHER	placebo	2 capsules of placebo

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-04-01
• Completion: 2019-11-01
• First posted: 2018-12-12
• Last updated: 2019-11-19

Locations

1 site across 1 country: Iran