Isoflavones and Peritoneal Dialysis

Not Applicable

Completed

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

• Registration Number: NCT04185168
• 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 serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa 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 fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-16
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35

Exclusion Criteria

infections inflammatory diseases liver diseases Clinical diagnosis 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 tablets)
control	control	2 tablets of placebo

Primary Outcome Measures

Name	Time	Method
fructoseamine	8 weeks	Serum concentrations of fructoseamine
carboxymethyl lysine	8 weeks	Serum concentrations of carboxymethyl lysine
Systolic blood pressure	8 weeks	Systolic blood pressure
pentosidine	8 weeks	Serum concentrations of pentosidine
glucose	8 weeks	Serum concentrations of glucose
Diastolic blood pressure	8 weeks	Diastolic blood pressure

Trial Locations

Locations (1)

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