Isoflavones and Peritoneal Dialysis

NCT04185168 | Completed

• 1 other identifier: 250
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa 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 fructoseamine, carboxymethyl lysine, pentosidine, glucose will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing

Conditions

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (6)

• glucose

  Serum concentrations of glucose

  8 weeks

• fructoseamine

  Serum concentrations of fructoseamine

  8 weeks

• carboxymethyl lysine

  Serum concentrations of carboxymethyl lysine

  8 weeks

• pentosidine

  Serum concentrations of pentosidine

  8 weeks

• Systolic blood pressure

  Systolic blood pressure

  8 weeks

• Diastolic blood pressure

  Diastolic blood pressure

  8 weeks

Study Arms (2)

isoflavone

ACTIVE COMPARATOR

100 mg soy isoflavone (as 2 tablets)

Dietary Supplement: soy isoflavone

control

PLACEBO COMPARATOR

2 tablets of placebo

Other: control

Interventions

soy isoflavone DIETARY_SUPPLEMENT

100 mg soy isoflavone (as 2 tablets)

isoflavone

control OTHER

2 tablets 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 Clinical diagnosis 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

Location

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

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 1, 2019
• First Posted: December 4, 2019
• Study Start: November 16, 2019
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

IR (1)