Investigation of the Effects of DASH and Standard Diets With and Without Curcumin Supplementation on Gene Expression of Interleukin-1 Alpha , 5 Alpha – Reductase, Serum Concentration of Testosterone and Glycemic Indices in Infertile Women With Polycystic Ovary Syndrome Candidate for In Vitro Fertilization (IVF)
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General information
2020-10-18, 1399/07/27
2022-04-03, 1401/01/14
20202022-1004-1803 00:00:00
2021-12-31, 1400/10/10
2022-07-23, 1401/05/01
20212022-1207-3123 00:00:00
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The start date of the study was changed and a second sponsor was added for the study
The start date of the study was changed and a second sponsor was added for the study
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تاریخ شروع مطالعه تغییر کرد و اسپانسر دوم برای مطالعه اضافه شد
تاریخ شروع مطالعه تغییر کرد و اسپانسر دوم برای مطالعه اضافه شد
Sponsors / Funding sources
#1
100
50
10050
#2
contact.organization_id:
Name of organization / entity - English: Iran National Science Foundation
Name of organization / entity - Persian: صندوق حمایت از پژوهشگران و فناوران ایران
Full name of responsible person - English: Dr. Eaman Eftekhary
Full name of responsible person - Persian: دکتر ایمان افتخاری
Street address - English: No. 33, Fifth Ave., North Karegar Ave., Tehran.
Street address - Persian: تهران - کارگر شمالی-خیابان پنجم- پلاک 33
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439634665
Phone: +98 21 8216 1000
Fax: +98 21 8800 3981
Email: info@insf.org
Web page address:
contact.organization_id: Name of organization / entity - English: Iran National Science Foundation Name of organization / entity - Persian: صندوق حمایت از پژوهشگران و فناوران ایران Full name of responsible person - English: Dr. Eaman Eftekhary Full name of responsible person - Persian: دکتر ایمان افتخاری Street address - English: No. 33, Fifth Ave., North Karegar Ave., Tehran. Street address - Persian: تهران - کارگر شمالی-خیابان پنجم- پلاک 33 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439634665 Phone: +98 21 8216 1000 Fax: +98 21 8800 3981 Email: info@insf.org Web page address:
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99019137
99019137
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Yes
1
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50
50
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Public
public
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Domestic
domestic
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Other
other
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Iran National Science Foundation
Iran National Science Foundation
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صندوق حمایت از پژوهشگران و فناوران ایران
صندوق حمایت از پژوهشگران و فناوران ایران
Protocol summary
Study aim
Investigate the effects of DASH diet and Curcumin on expression of Interleukin 1 Alpha , 5 Alpha reductase and androgenic and glycemic profile, in women with polycystic ovary syndrome (PCOS)
Design
A randomized, double-blind, placebo-controlled trial, with a 2*2 factorial design; 96 patients will be randomly assigned to four groups using a Stratified Permuted Block Randomization, in equal block sizes of 4; by Package ‘blockrand’ in R software, 4.0.2 version.
Settings and conduct
Study will be conducted at Yazd Reproductive Sciences Institute; dietary assessing, blood sampling, analysis of body composition and anthropometric indices will be performed; mRNA expression levels, androgenic and glycemic profile will be evaluated by using Real-Time PCR and ELISA methods, respectively. After 12 weeks, all of the above steps will be repeated. Curcumin and placebo will be provided in similar bottles with different letters (A, B; labeled by someone not related to the study); participants and researchers will not be aware of bottles content.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infertile women with PCOS, aged 18–40 years, candidate for In Vitro Fertilization; Major exclusion criteria: having metabolic abnormalities, hypertension, cancer and mental illness; taking anti-diabetic, androgenic and contraceptives drugs.
Intervention groups
All participants will receive Curcumin or placebo (500 mg twice daily) plus individual diet (DASH or standard); 1) Curcumin plus DASH diet; 2) Curcumin plus standard diet; 3) Placebo plus DASH diet; 4) Placebo plus standard diet.
Main outcome variables
Expression values of interleukin-1 alpha and 5 alpha – reductase genes; Serum levels of testosterone and 5α-dihydrotestosterone; FBS, insulin and homeostasis model assessment of insulin resistance.
General information
Reason for update
The start date of the study was changed and a second sponsor was added for the study
Acronym
IRCT registration information
IRCT registration number:IRCT20200915048731N1
Registration date:2020-09-29, 1399/07/08
Registration timing:prospective
Last update:2021-12-30, 1400/10/09
Update count:3
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Tayebeh Zohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3149 2237
Email address
zohrabitayebeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effects of DASH and Standard Diets With and Without Curcumin Supplementation on Gene Expression of Interleukin-1 Alpha , 5 Alpha – Reductase, Serum Concentration of Testosterone and Glycemic Indices in Infertile Women With Polycystic Ovary Syndrome Candidate for In Vitro Fertilization (IVF)
Public title
Effect of diet therapy with and without Curcumin in treatment of Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women with PCOS diagnosed according to Rotterdam criteria.
Aged 18–40 years
Candidate for IVF without previous history of IVF
Exclusion criteria:
Participants with metabolic abnormalities including thyroid dysfunction, diabetes or impaired glucose tolerance, and cardiovascular disease
Patients with Hyperprolactinemia, Congenital adrenal hyperplasia, Cushing's syndrome
Patients with Kidney disease, hypertension, liver disease, cancer and known mental illness
Smoking by the patient or her spouse
Alcohol drinking
Taking contraceptives or any other drugs that may affect reproductive physiology (during the three months before the study)
Taking anti-diabetic, anti-obesity, estrogenic and androgenic drugs
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to four groups according to the method of Stratified Permuted Block Randomization based on BMI (BMI<25 and BMI ≥25), in equal block sizes of 4; Therefore, participants will have an equal chance for being in each group. A random allocation list will be created by Package ‘blockrand’ in R software, 4.0.2 version.
The intervention groups will be randomly allocated into 4 groups:
Group 1: 500 mg Curcumin twice daily and DASH diet,
Group 2: 500 mg Curcumin twice daily and standard diet,
Group 3: 500 mg Placebo twice daily and DASH diet,
Group 4: 500 mg Placebo twice daily and standard diet.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebos capsules will be provided in the same appearance (in terms of color and shape) and packed in similar bottles. The bottles will be labeled with different marks (A and B), by someone not related to the study. Each bottle contains 64 capsules (for one-month usage). Participants and researchers will not be aware of bottles content. As well as intervention groups will be assigned to receive two different diets (DASH or standard diet). Diets for each participant will be provided during a face to face nutrition consultation by a nutritionist who is not involved in the study; in our opinion, this study is double-blind, because all the researchers and final analysts will remain conceal from the allocation and will not be able to distinguish between groups. Participants will only aware of the type of diet but will not know the content of placebo or curcumin supplement.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Science
Street address
Safaeiye Ave., Alam Square., Shahid Sadoughi University of Medical Science., Yazd.
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
ir.ssu.sph.rec.1399.145
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
Interleukin 1 Alpha gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real time Polymerase Chain Reaction (PCR)
2
Description
5 Alpha reductase gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real time Polymerase Chain Reaction (PCR)
Secondary outcomes
1
Description
Testosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa method
2
Description
5α-dihydrotestosterone
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa method
3
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa method
4
Description
Homeostasis model assessment of insulin resistance (HOMA-IR)
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA-IR formula
5
Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic method
6
Description
Anthropometric indices
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Anthropometric indices will be measure, including weight using calibrated Seca scale with an accuracy of 0.1 kg and a minimum of clothes ; height, waist and hip circumference using a tape measure with an accuracy of 0.5 cm; as well as Body Mass Index and waist-hip ratio will be calculated.
7
Description
Body composition
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Measurement of body composition, including fat mass, and fat free mass using Bioelectric Impedance Analyzer ( BIA)
8
Description
Energy and nutrient intake
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Using 3 Days food record (2 days per week and one day off) and analyzing with Nutritionist 4 software
Intervention groups
1
Description
"Intervention group 1:" Curcumin capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. The Dietary Approaches to Stop Hypertension (DASH) diet is a diet that emphasizes vegetables, fruits and low-fat dairy products; and moderate amounts of whole grains, poultry, fish, and nuts; while it contains only small amounts of red meat, sweets, and sugar-containing beverages. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively
Category
Treatment - Drugs
2
Description
"Intervention group 2:" Curcumin capsules and standard diet; in this intervention group, 24 patients will receive 500 milligrams of Curcumin capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually.The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.
Category
Treatment - Drugs
3
Description
"Intervention group 3:" Placebos capsules and DASH diet; in this intervention group, 24 patients will receive 500 milligrams of placebo capsule twice daily and DASH diet for 12 weeks, each person's diet will designed individually. Placebos capsules will be provided in the similar appearance with curcumin capsules (in terms of color and shape) and packed in same bottles. The DASH diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively
Category
Treatment - Other
4
Description
"Control group:" Placebos capsules and standard diet; in this group, 24 patients will receive 500 milligrams of placebo capsule twice daily and standard diet for 12 weeks, each person's diet will designed individually. The standard diet will be designed to contain 52 % carbohydrates, 18 % protein, and 30 % total fat; if a person is overweight or obese, the patient's calculated energy will be reduced by 300 and 500 kcal, respectively.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Tayebeh zohrabi
Street address
Yazd reproductive sciences institute, BouAl i Ave., Safaeih, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
zohrabitayebeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Research Deputy of Health Faculty
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
zohrabitayebeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Dr. Eaman Eftekhary
Street address
No. 33, Fifth Ave., North Karegar Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1439634665
Phone
+98 21 8216 1000
Fax
+98 21 8800 3981
Email
info@insf.org
Grant name
Grant code / Reference number
99019137
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tayebeh Zohrabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
zohrabitayebeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hassan Mozaffari Khosravi
Position
Professor (Full)
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
mozaffari.kh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Tayebeh Zohrabi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Safaeiye Ave., Alam Square., Public Health faculty., Shahid Sadoughi University of Medical Science., Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
zohrabitayebeh@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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I have not yet decided on this.
When the data will become available and for how long
I have not yet decided on this.
To whom data/document is available
I have not yet decided on this.
Under which criteria data/document could be used
I have not yet decided on this.
From where data/document is obtainable
I have not yet decided on this.
What processes are involved for a request to access data/document