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

November 15, 2019 updated by: zahra yari, National Nutrition and Food Technology Institute

Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
    • Iran (the Islamic Republic Of)
      • Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of, 1981619573
        • Recruiting
        • National Nutrition and Food Technology Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: isoflavone
100 mg soy isoflavone (as 2 capsules)
Dietary supplement: soy isoflavone
100 mg soy isoflavone (as 2 capsules)
PLACEBO_COMPARATOR: control
2 capsules of placebo
Other: placebo
2 capsules of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lp (a)
Time Frame: 8 weeks
Serum concentrations of lipoprotein-a
8 weeks
MDA
Time Frame: 8 weeks
Serum concentrations of malondialdehyde
8 weeks
hs-CRP
Time Frame: 8 weeks
Serum concentrations of high sensitivity c-reactive protein
8 weeks
sICAM-1
Time Frame: 8 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
8 weeks
bone alkaline phosphatase
Time Frame: 8 weeks
Serum concentrations of bone alkaline phosphatase
8 weeks
osteocalcin
Time Frame: 8 weeks
Serum concentrations of osteocalcin
8 weeks
N-telopeptide
Time Frame: 8 weeks
Serum concentrations of N-telopeptide
8 weeks
Osteoprotegerin
Time Frame: 8 weeks
Serum concentrations of Osteoprotegerin
8 weeks
RANKL
Time Frame: 8 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
8 weeks
triglyceride
Time Frame: 8 weeks
Serum concentrations of triglyceride
8 weeks
total cholesterol
Time Frame: 8 weeks
Serum concentrations of total cholesterol
8 weeks
HDL-C
Time Frame: 8 weeks
Serum concentrations of High-density lipoprotein cholesterol
8 weeks
LDL-C
Time Frame: 8 weeks
Serum concentrations of low-density lipoprotein cholesterol
8 weeks
sVCAM-1
Time Frame: 8 weeks
Serum concentrations of Soluble vascular adhesion molecule-1
8 weeks
E-selectin
Time Frame: 8 weeks
Serum concentrations of E-selectin
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
albumin
Time Frame: 8 weeks
Serum concentrations of albumin
8 weeks
calcium
Time Frame: 8 weeks
Serum concentrations of calcium
8 weeks
phosphorous
Time Frame: 8 weeks
Serum concentrations of phosphorous
8 weeks
iPTH
Time Frame: 8 weeks
Serum concentrations of Intact parathyroid hormone
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (ACTUAL)

December 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1397.247

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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