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

Not Applicable

• Conditions: Peritoneal Dialysis Patients
• Interventions: Dietary Supplement: soy isoflavone; Other: placebo

• Registration Number: NCT03773029
• Lead Sponsor: National Nutrition and Food Technology Institute

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Study Start: 2019-01-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isoflavone	soy isoflavone	100 mg soy isoflavone (as 2 capsules)
control	placebo	2 capsules of placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
calcium	8 weeks	Serum concentrations of calcium
albumin	8 weeks	Serum concentrations of albumin
phosphorous	8 weeks	Serum concentrations of phosphorous
iPTH	8 weeks	Serum concentrations of Intact parathyroid hormone

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of