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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| isoflavone | Active Comparator | 100 mg soy isoflavone (as 2 tablets) |
|
| control | Placebo Comparator | 2 tablets of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavone | Dietary Supplement | 100 mg soy isoflavone (as 2 tablets) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| glucose | Serum concentrations of glucose | 8 weeks |
| fructoseamine | Serum concentrations of fructoseamine | 8 weeks |
| carboxymethyl lysine | Serum concentrations of carboxymethyl lysine | 8 weeks |
| pentosidine | Serum concentrations of pentosidine | 8 weeks |
| Systolic blood pressure | Systolic blood pressure | 8 weeks |
| Diastolic blood pressure | Diastolic blood pressure | 8 weeks |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Tehran | Iran (the Islamic Republic Of) | 1981619573 | Iran |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| control |
| Other |
2 tablets of placebo |
|
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |