The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients

National Nutrition and Food Technology Institute

Status: Unknown

Conditions: Peritoneal Dialysis Patients

Treatments: Other: placebo; Dietary Supplement: soy isoflavone

Study type: Interventional

Funder types: Other

Identifiers

NCT03773029

1397.247

Details and patient eligibility

About

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

Enrollment: 47 estimated 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; 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups, including a placebo group

isoflavone

Active Comparator group

Description:

100 mg soy isoflavone (as 2 capsules)

Treatment:

Dietary Supplement: soy isoflavone

control

Placebo Comparator group

Description:

2 capsules of placebo

Treatment:

Other: placebo