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Protocol summary
Patients in the isoflavone group receive, for 10 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.
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.
Patients in the isoflavone group receive, for 108 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.
بيماران گروه ایزوفلاون، به مدت 10 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند. بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 10 هفته دريافت خواهند كرد.
بيماران گروه ایزوفلاون، به مدت 8 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند. بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 10 هفته دريافت خواهند كرد.
بيماران گروه ایزوفلاون، به مدت 108 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند. بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 10 هفته دريافت خواهند كرد.
Primary outcomes
#1
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
#2
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
#3
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
#4
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
#5
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
#6
Before the intervention and 10 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention and 108 weeks after the intervention
قبل از شروع مداخله و 10 هفته پس از آن
قبل از شروع مداخله و 8 هفته پس از آن
قبل از شروع مداخله و 108 هفته پس از آن
Intervention groups
#1
Intervention group: Patients in the isoflavone group receive, for 10 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
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.
Intervention group: Patients in the isoflavone group receive, for 108 weeks, two tablets of Soyagol (Goldaru Company) per day, each containing 50 mg of soy isoflavone.
گروه مداخله: بيماران گروه ایزوفلاون، به مدت 10 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند.
گروه مداخله: بيماران گروه ایزوفلاون، به مدت 8 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند.
گروه مداخله: بيماران گروه ایزوفلاون، به مدت 108 هفته، روزانه دو عدد قرص سوياگل (شرکت گل دارو) که هر کدام حاوي 50 ميلي گرم مکمل ایزوفلاون سویا مي باشد را دريافت مي كنند.
#2
Control group: Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 10 weeks.
Control group: Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 8 weeks.
Control group: Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 108 weeks.
گروه کنترل: بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 10 هفته دريافت خواهند كرد.
گروه کنترل: بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 8 هفته دريافت خواهند كرد.
گروه کنترل: بيماران گروه دارونما نيز روزانه 2 قرص دارونما (شرکت گل دارو) حاوي نشاسته را به مدت 108 هفته دريافت خواهند كرد.
Protocol summary
Study aim
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
Design
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.
Settings and conduct
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
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Serum concentrations of glucose, fructoseamine, carboxymethyl lysine, pentosidine
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Hadi Tabibi
Name of organization / entity
Department of Human Nutrition, Faculty of Nutrition Sciences and Food Technology,Shahid Beheshti Uni
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 7424
Email address
nsft@hbi.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-01-23, 1398/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of isoflavones on hypertension, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients
Public title
Effects of isoflavones in peritoneal dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods,
City
Tehran
Province
Tehran
Postal code
1381619573
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1397.038
Health conditions studied
1
Description of health condition studied
End stage of renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum concentrations of glucose
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Enzymatic method
2
Description
Serum concentrations of fructoseamine
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
3
Description
Serum concentrations of carboxymethyl lysine
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
4
Description
Serum concentrations of pentosidine
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The enzyme-linked immunosorbent assay (ELISA)
5
Description
Systolic blood pressure
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
mercury sphygmomanometer
6
Description
Diastolic blood pressure
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will also receive 2 tablets of placebo containing starch (Goldaru Company) per day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Clinic
Full name of responsible person
Shahnaz Atabak
Street address
No 42, Hosseini Ave., Valiasr Square
City
Tehran
Province
Tehran
Postal code
6182965723
Phone
+98 21 8889 6051
Email
Info@irankf.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Nutrition and Food Technology Research Institute
Full name of responsible person
Dr. Esmat Naseri
Street address
No. 46, West Arghavan St., Farahzadi Blv., Shahrak Qods,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Email
nutrition@sbmu.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Nutrition and Food Technology Research Institute
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Technology, Shahid Beheshti medical university
Full name of responsible person
Dr. Hadi Tabibi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
hadtabibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nutrition and Food Technology, Shahid Beheshti medical university
Full name of responsible person
Dr. Hadi Tabibi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
hadtabibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nutrition and Food Technology, Shahid Beheshti medical university
Full name of responsible person
Dr. Hadi Tabibi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
46, West Arghavan St., Farahzadi Blv., Shahrak Qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Email
hadtabibi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available