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General information
empty
The revisions were accordance with the original approved proposal.
The revisions were accordance with the original approved proposal.
empty
اصلاحات صورت گرفته مطابق با پروپوزال اصلی تصویب شده بود.
اصلاحات صورت گرفته مطابق با پروپوزال اصلی تصویب شده بود.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shabihkhani clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Kosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the ShabihkhaniKosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شبیه خوانی که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک کوثر که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شبیه خوانیکوثر که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of curcumin supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Design
Study design: Randomized double-blind placebo-controlled trial, All participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two groups. Randomization will be done by the use of computer software.
Settings and conduct
Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Individuals with neoplastic disorders, cardiovascular diseases, malabsorptive disorders, and current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications
Intervention groups
Intervention group: 500 mg curcumin, once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Main outcome variables
Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles and gene expression related to insulin and lipid (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The revisions were accordance with the original approved proposal.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N50
Registration date:2019-03-20, 1397/12/29
Registration timing:retrospective
Last update:2020-01-30, 1398/11/10
Update count:1
Registration date
2019-03-20, 1397/12/29
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-23, 1397/11/03
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin supplementation on metabolic profiles and gene expression related to insulin and lipid in women with polycystic ovary syndrome
Public title
The effect of curcumin supplementation in treatment of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with polycystic ovary syndrome
Individuals aged 18 to 40 years
Exclusion criteria:
Individuals with neoplastic disorders
cardiovascular diseases
malabsorptive disorders
current or previous (within the last 6 months) use of hormonal; antidiabetic and anti-obesity medications.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<30 and ≥30 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Kosar clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.ARAKMU.REC.1397.299
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
2
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
2
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
3
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
4
Description
Expressed levels of GLUT-1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
5
Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
6
Description
Expressed levels of LDL-R gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
Intervention groups
1
Description
Intervention group: 500 mg curcumin , once a day, for 12 weeks orally
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mehri Jamilian
Street address
Emam Khomeyni Avenue, Arak
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
jamilian_m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Sardasht Avenue, Vice chancellor for research, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
1771844351
Phone
+98 31 5546 3378
Email
Arjomandzadegan.M@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
1771844351
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available