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Clinical Trials/NCT04185168
NCT04185168
Completed
Not Applicable

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

National Nutrition and Food Technology Institute1 site in 1 country38 target enrollmentNovember 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peritoneal Dialysis
Sponsor
National Nutrition and Food Technology Institute
Enrollment
38
Locations
1
Primary Endpoint
pentosidine
Status
Completed
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 16, 2019
End Date
January 18, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Nutrition and Food Technology Institute
Responsible Party
Principal Investigator
Principal Investigator

zahra yari

Principal Investigator

National Nutrition and Food Technology Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

pentosidine

Time Frame: 8 weeks

Serum concentrations of pentosidine

fructoseamine

Time Frame: 8 weeks

Serum concentrations of fructoseamine

carboxymethyl lysine

Time Frame: 8 weeks

Serum concentrations of carboxymethyl lysine

Systolic blood pressure

Time Frame: 8 weeks

Systolic blood pressure

glucose

Time Frame: 8 weeks

Serum concentrations of glucose

Diastolic blood pressure

Time Frame: 8 weeks

Diastolic blood pressure

Study Sites (1)

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