Isoflavones and Peritoneal Dialysis

Peritoneal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185168
• Other study ID #: 250
• Status: Completed
• Phase: N/A
• Start date: November 16, 2019
• Est. completion date: January 18, 2020

Study information

• Verified date: February 2020
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• 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 Clinical diagnosis 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

Intervention

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

Other:
• control
2 tablets 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	glucose	Serum concentrations of glucose	8 weeks
Primary	fructoseamine	Serum concentrations of fructoseamine	8 weeks
Primary	carboxymethyl lysine	Serum concentrations of carboxymethyl lysine	8 weeks
Primary	pentosidine	Serum concentrations of pentosidine	8 weeks
Primary	Systolic blood pressure	Systolic blood pressure	8 weeks
Primary	Diastolic blood pressure	Diastolic blood pressure	8 weeks