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The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's 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 Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous 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 capsules) |
|
| control | Placebo Comparator | 2 capsules of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavone | Dietary Supplement | 100 mg soy isoflavone (as 2 capsules) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lp (a) | Serum concentrations of lipoprotein-a | 8 weeks |
| MDA | Serum concentrations of malondialdehyde | 8 weeks |
| hs-CRP | Serum concentrations of high sensitivity c-reactive protein | 8 weeks |
| sICAM-1 | Serum concentrations of Soluble intercellular adhesion molecule-1 | 8 weeks |
| bone alkaline phosphatase | Serum concentrations of bone alkaline phosphatase | 8 weeks |
| osteocalcin | Serum concentrations of osteocalcin | 8 weeks |
| N-telopeptide | Serum concentrations of N-telopeptide | 8 weeks |
| Osteoprotegerin | Serum concentrations of Osteoprotegerin | 8 weeks |
| RANKL | Serum concentrations of Receptor activator of nuclear factor kappa-Î’ ligand |
| Measure | Description | Time Frame |
|---|---|---|
| albumin | Serum concentrations of albumin | 8 weeks |
| calcium | Serum concentrations of calcium | 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; past medical history 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zahra yari | Contact | +982122357484 | zahrayari_nut@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Recruiting | Tehran | Iran (the Islamic Republic Of) | 1981619573 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32513581 | Derived | Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients. Nutr Metab Cardiovasc Dis. 2020 Jul 24;30(8):1382-1388. doi: 10.1016/j.numecd.2020.04.023. Epub 2020 May 5. | |
| 32488754 | Derived | Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of isoflavones on bone turnover markers in peritoneal dialysis patients: a randomized controlled trial. Int Urol Nephrol. 2020 Jul;52(7):1367-1376. doi: 10.1007/s11255-020-02523-w. Epub 2020 Jun 1. |
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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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| placebo |
| Other |
2 capsules of placebo |
|
| 8 weeks |
| triglyceride | Serum concentrations of triglyceride | 8 weeks |
| total cholesterol | Serum concentrations of total cholesterol | 8 weeks |
| HDL-C | Serum concentrations of High-density lipoprotein cholesterol | 8 weeks |
| LDL-C | Serum concentrations of low-density lipoprotein cholesterol | 8 weeks |
| sVCAM-1 | Serum concentrations of Soluble vascular adhesion molecule-1 | 8 weeks |
| E-selectin | Serum concentrations of E-selectin | 8 weeks |
| phosphorous | Serum concentrations of phosphorous | 8 weeks |
| iPTH | Serum concentrations of Intact parathyroid hormone | 8 weeks |
| 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 |