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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03773029
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : November 19, 2019
Information provided by (Responsible Party):
zahra yari, National Nutrition and Food Technology Institute

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

Condition or disease Intervention/treatment Phase
Peritoneal Dialysis Patients Dietary Supplement: soy isoflavone Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : April 1, 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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

Primary Outcome Measures :
  1. Lp (a) [ Time Frame: 8 weeks ]
    Serum concentrations of lipoprotein-a

  2. MDA [ Time Frame: 8 weeks ]
    Serum concentrations of malondialdehyde

  3. hs-CRP [ Time Frame: 8 weeks ]
    Serum concentrations of high sensitivity c-reactive protein

  4. sICAM-1 [ Time Frame: 8 weeks ]
    Serum concentrations of Soluble intercellular adhesion molecule-1

  5. bone alkaline phosphatase [ Time Frame: 8 weeks ]
    Serum concentrations of bone alkaline phosphatase

  6. osteocalcin [ Time Frame: 8 weeks ]
    Serum concentrations of osteocalcin

  7. N-telopeptide [ Time Frame: 8 weeks ]
    Serum concentrations of N-telopeptide

  8. Osteoprotegerin [ Time Frame: 8 weeks ]
    Serum concentrations of Osteoprotegerin

  9. RANKL [ Time Frame: 8 weeks ]
    Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand

  10. triglyceride [ Time Frame: 8 weeks ]
    Serum concentrations of triglyceride

  11. total cholesterol [ Time Frame: 8 weeks ]
    Serum concentrations of total cholesterol

  12. HDL-C [ Time Frame: 8 weeks ]
    Serum concentrations of High-density lipoprotein cholesterol

  13. LDL-C [ Time Frame: 8 weeks ]
    Serum concentrations of low-density lipoprotein cholesterol

  14. sVCAM-1 [ Time Frame: 8 weeks ]
    Serum concentrations of Soluble vascular adhesion molecule-1

  15. E-selectin [ Time Frame: 8 weeks ]
    Serum concentrations of E-selectin

Secondary Outcome Measures :
  1. albumin [ Time Frame: 8 weeks ]
    Serum concentrations of albumin

  2. calcium [ Time Frame: 8 weeks ]
    Serum concentrations of calcium

  3. phosphorous [ Time Frame: 8 weeks ]
    Serum concentrations of phosphorous

  4. iPTH [ Time Frame: 8 weeks ]
    Serum concentrations of Intact parathyroid hormone

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03773029

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Contact: zahra yari +982122357484

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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute Recruiting
Tehran, Iran (the Islamic Republic Of), Iran, Islamic Republic of, 1981619573
Contact: Zahra Yari    +982122357484   
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: zahra yari, Principal Investigator, National Nutrition and Food Technology Institute Identifier: NCT03773029    
Other Study ID Numbers: 1397.247
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No