Protocol summary
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Study aim
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The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on hypertension, serum concentrations of glucose, fructoseamine and advanced glycated end products in peritoneal dialysis patients
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Design
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This study is a double-blind, randomized controlled clinical trial with two parallel groups. 44 patients will be randomly assigned into isoflavone and control group.
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Settings and conduct
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Patients under peritoneal dialysis referring to the peritoneal dialysis unit of Shafa clinic are invited to participate in this research, and the research goals and method will be explained for them.
For double blind implementation, at the beginning of the study, all boxes containing soybean isoflavone or placebo by a third party (someone other than the researchers) is coded as A and B
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Participants/Inclusion and exclusion criteria
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Inclusion criterion: 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
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Intervention groups
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Patients in the isoflavone group receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 10 weeks.
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Main outcome variables
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Serum concentrations of glucose, fructoseamine, carboxymethyl lysine, pentosidine
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091116002716N4
Registration date:
2019-12-22, 1398/10/01
Registration timing:
registered_while_recruiting
Last update:
2019-12-23, 1398/10/02
Update count:
1
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Registration date
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2019-12-22, 1398/10/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-16, 1398/08/25
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Expected recruitment end date
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2020-01-23, 1398/11/03
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of isoflavones on hypertension, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients
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Public title
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Effects of isoflavones in peritoneal dialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 75 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation is Stratified Blocked Randomization (based on diabetes mellitus). The unit of allocation is the individual people. Investigators will be blind to group allocation.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study is a double-blind (investigators and patients) trial. For double-blind implementation, at the beginning of the study, all boxes containing soybean isoflavone or placebo by a third party (someone other than the researchers) is coded as A and B.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-01, 1397/10/11
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Ethics committee reference number
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IR.SBMU.NNFTRI.REC.1397.038
Health conditions studied
1
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Description of health condition studied
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End stage of renal disease
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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Serum concentrations of glucose
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Enzymatic method
2
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Description
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Serum concentrations of fructoseamine
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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The enzyme-linked immunosorbent assay (ELISA)
3
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Description
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Serum concentrations of carboxymethyl lysine
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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The enzyme-linked immunosorbent assay (ELISA)
4
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Description
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Serum concentrations of pentosidine
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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The enzyme-linked immunosorbent assay (ELISA)
5
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Description
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Systolic blood pressure
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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mercury sphygmomanometer
6
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Description
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Diastolic blood pressure
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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mercury sphygmomanometer
Intervention groups
1
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Description
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Intervention group: Patients in the isoflavone group receive, for 8 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
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Category
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Treatment - Other
2
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Description
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Control group: Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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National Nutrition and Food Technology Research Institute
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable