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Effect of isoflavones supplementation in peritoneal dialysis patients

Effects of isoflavones on cardiovascular disease risk factors and bone metabolism markers in peritoneal dialysis patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181120041710N1
Enrollment
44
Registered
2019-01-10
Start date
2018-11-28
Completion date
Unknown
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peritoneal dialysis patients. Chronic kidney disease, stage 5

Interventions

Intervention 1: Intervention group: isoflavone supplementation: they will receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone. Intervention

Sponsors

National Nutrition and Food Technology Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index (BMI) below 35

Exclusion criteria

Exclusion criteria: Infectious diseases (especially peritonitis) and inflammatory diseases Liver diseases Past medical history of cancer Receiving glucocorticoid drugs, non-steroidal anti-inflammatory drugs Receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet

Design outcomes

Primary

MeasureTime frame
Serum concentrations of lipoprotein(a) [Lp (a)]. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Serum concentrations of malondialdehyde (MDA). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Serum concentrations of high sensitivity c-reactive protein (hs-CRP). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Serum concentrations of Soluble intercellular adhesion molecule-1 (sICAM-1). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kit.;Serum concentrations of bone alkaline phosphatase. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of Osteocalcin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of N-telopeptide. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of Osteoprotegerin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of Receptor activator of nuclear factor kappa-? ligand (RANKL). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of Intact parathyroid hormone (iPTH). Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: The enzyme-linked immunosorbent assay (ELISA).;Serum concentrations of triglycerid

Secondary

MeasureTime frame
Serum concentrations of albumin. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Enzymatic assay kit.;Serum concentrations of calcium. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Colorimetric method using autoanalyzer.;Serum concentrations of phosphorous. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Colorimetric method using autoanalyzer.;Blood nitrogen urea. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Colorimetric method.;Creatinine. Timepoint: Before the intervention and 8 weeks after the intervention. Method of measurement: Colorimetric method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Yari

Shahid Beheshti University of Medical Sciences

zahrayari_nut@yahoo.com+98 21 2207 7424

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026