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

NCT03773029 | Unknown

• 1 other identifier: 1397.247
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Peritoneal Dialysis Patients

Outcome Measures

Primary Outcomes (15)

• 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-Β ligand

  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

Secondary Outcomes (4)

• albumin

  8 weeks

• calcium

  8 weeks

• phosphorous

  8 weeks

• iPTH

  8 weeks

Study Arms (2)

isoflavone

ACTIVE COMPARATOR

100 mg soy isoflavone (as 2 capsules)

Dietary Supplement: soy isoflavone

control

PLACEBO COMPARATOR

2 capsules of placebo

Other: placebo

Interventions

soy isoflavone DIETARY_SUPPLEMENT

100 mg soy isoflavone (as 2 capsules)

isoflavone

placebo OTHER

2 capsules of placebo

control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran (the Islamic Republic Of), 1981619573, Iran

RECRUITING

Related Publications (2)

• 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.

  PMID: 32513581 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.

  PMID: 32488754 DERIVED

MeSH Terms

Interventions

Soybean Proteins

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Central Study Contacts

zahra yari

CONTACT

+982122357484; zahrayari_nut@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 12, 2018
• Study Start: January 1, 2019
• Primary Completion: April 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 19, 2019

Record last verified: 2018-12

Locations

IR (1)