Skip to main content
OpenTrials
Completed

NCT Number: NCT04185168

Isoflavones and Peritoneal Dialysis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peritoneal Dialysis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Nutrition and Food Technology Research Institute

Tehran, Iran (the Islamic Republic Of), 1981619573, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

soy isoflavone

Dietary Supplement

100 mg soy isoflavone (as 2 tablets)

Control

Other

2 tablets of placebo

Primary outcomes

  1. glucose

    Time frame: 8 weeks

    Serum concentrations of glucose

  2. fructoseamine

    Time frame: 8 weeks

    Serum concentrations of fructoseamine

  3. carboxymethyl lysine

    Time frame: 8 weeks

    Serum concentrations of carboxymethyl lysine

  4. pentosidine

    Time frame: 8 weeks

    Serum concentrations of pentosidine

  5. Systolic blood pressure

    Time frame: 8 weeks

    Systolic blood pressure

  6. Diastolic blood pressure

    Time frame: 8 weeks

    Diastolic blood pressure

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

Effects of Isoflavones on Hypertension, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.