Clinical trial NCT03773029: The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
Official title: Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritoneal Dialysis Patients
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Lp (a)
timeFrame: 8 weeks
measure: MDA
timeFrame: 8 weeks
measure: hs-CRP
timeFrame: 8 weeks
measure: sICAM-1
timeFrame: 8 weeks
measure: bone alkaline phosphatase
timeFrame: 8 weeks
measure: osteocalcin
timeFrame: 8 weeks
measure: N-telopeptide
timeFrame: 8 weeks
measure: Osteoprotegerin
timeFrame: 8 weeks
measure: RANKL
timeFrame: 8 weeks
measure: triglyceride
timeFrame: 8 weeks
measure: total cholesterol
timeFrame: 8 weeks
measure: HDL-C
timeFrame: 8 weeks
measure: LDL-C
timeFrame: 8 weeks
measure: sVCAM-1
timeFrame: 8 weeks
measure: E-selectin
timeFrame: 8 weeks
Secondary outcomes:
measure: albumin
timeFrame: 8 weeks
measure: calcium
timeFrame: 8 weeks
measure: phosphorous
timeFrame: 8 weeks
measure: iPTH
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Iran (the Islamic Republic Of)
Study officials:
References:
citation: 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.
citation: 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.