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Isoflavones and Peritoneal Dialysis

N

National Nutrition and Food Technology Institute

Status

Completed

Conditions

Peritoneal Dialysis

Treatments

Dietary Supplement: soy isoflavone
Other: control

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

38 participants in 2 patient groups, including a placebo group

isoflavone
Active Comparator group
Description:
100 mg soy isoflavone (as 2 tablets)
Treatment:
Dietary Supplement: soy isoflavone
control
Placebo Comparator group
Description:
2 tablets of placebo
Treatment:
Other: control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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