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

Peritoneal Dialysis Patients Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03773029
• Other study ID #: 1397.247
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: November 2019

Study information

• Verified date: December 2018
• Source: National Nutrition and Food Technology Institute
• Contact: zahra yari
• Phone: +982122357484
• Email: zahrayari_nut[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: November 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis Patients

Intervention

Dietary Supplement:
• soy isoflavone
100 mg soy isoflavone (as 2 capsules)

Other:
• placebo
2 capsules of placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran	Iran (the Islamic Republic Of)

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lp (a)	Serum concentrations of lipoprotein-a	8 weeks
Primary	MDA	Serum concentrations of malondialdehyde	8 weeks
Primary	hs-CRP	Serum concentrations of high sensitivity c-reactive protein	8 weeks
Primary	sICAM-1	Serum concentrations of Soluble intercellular adhesion molecule-1	8 weeks
Primary	bone alkaline phosphatase	Serum concentrations of bone alkaline phosphatase	8 weeks
Primary	osteocalcin	Serum concentrations of osteocalcin	8 weeks
Primary	N-telopeptide	Serum concentrations of N-telopeptide	8 weeks
Primary	Osteoprotegerin	Serum concentrations of Osteoprotegerin	8 weeks
Primary	RANKL	Serum concentrations of Receptor activator of nuclear factor kappa-? ligand	8 weeks
Primary	triglyceride	Serum concentrations of triglyceride	8 weeks
Primary	total cholesterol	Serum concentrations of total cholesterol	8 weeks
Primary	HDL-C	Serum concentrations of High-density lipoprotein cholesterol	8 weeks
Primary	LDL-C	Serum concentrations of low-density lipoprotein cholesterol	8 weeks
Primary	sVCAM-1	Serum concentrations of Soluble vascular adhesion molecule-1	8 weeks
Primary	E-selectin	Serum concentrations of E-selectin	8 weeks
Secondary	albumin	Serum concentrations of albumin	8 weeks
Secondary	calcium	Serum concentrations of calcium	8 weeks
Secondary	phosphorous	Serum concentrations of phosphorous	8 weeks
Secondary	iPTH	Serum concentrations of Intact parathyroid hormone	8 weeks