Peritoneal Dialysis
Conditions
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
Interventions
DIETARY_SUPPLEMENTsoy isoflavone
100 mg soy isoflavone (as 2 tablets)
OTHERcontrol
2 tablets of placebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glucose | 8 weeks | Serum concentrations of glucose |
| fructoseamine | 8 weeks | Serum concentrations of fructoseamine |
| carboxymethyl lysine | 8 weeks | Serum concentrations of carboxymethyl lysine |
| pentosidine | 8 weeks | Serum concentrations of pentosidine |
| Systolic blood pressure | 8 weeks | Systolic blood pressure |
| Diastolic blood pressure | 8 weeks | Diastolic blood pressure |
Countries
Iran
Outcome results
None listed