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Sharing plan
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
undecided
yes
undecidedyes
There is no further information
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There is no further information
اطلاعات بیشتری وجود ندارد
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اطلاعات بیشتری وجود ندارد
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The title of the data will be ‘’the effect of Modified intermittent Fasting Diet on the severity of Premenstrual Syndrome and Quality of Life ’’. All data can be shared after making participants anonymous.
The title of the data will be ‘’the effect of Modified intermittent Fasting Diet on the severity of Premenstrual Syndrome and Quality of Life ’’. All data can be shared after making participants anonymous.
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عنوان داده ها اثررژیم فستینگ متناوب اصلاح شده بر شدت علایم سندروم پیش از قاعدگی و کیفیت زندگی خواهد بود. کل داده ها پس از غیرقابل شناسایی کردن افراد قابل اشتراک گذاری است.
عنوان داده ها اثررژیم فستینگ متناوب اصلاح شده بر شدت علایم سندروم پیش از قاعدگی و کیفیت زندگی خواهد بود. کل داده ها پس از غیرقابل شناسایی کردن افراد قابل اشتراک گذاری است.
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Six months after publishing results, everything will be accessible.
Six months after publishing results, everything will be accessible.
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شروع دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
شروع دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
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The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
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داده های این پژوهش صرفاً در اختیار محققین حوزه سلامت و شاغل در مؤسسات دانشگاهی و علمی قرار خواهد گرفت.
داده های این پژوهش صرفاً در اختیار محققین حوزه سلامت و شاغل در مؤسسات دانشگاهی و علمی قرار خواهد گرفت.
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With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination.
With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination.
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از داده های این پژوهش با رعایت ملاحظات اخلاقی می توان در سایر اهداف پژوهشی استفاده کرد. انجام هرگونه تجزیه و تحلیل آماری بلامانع است. انجام تمام این فرایندها مستلزم مکاتبه و هماهنگی است.
از داده های این پژوهش با رعایت ملاحظات اخلاقی می توان در سایر اهداف پژوهشی استفاده کرد. انجام هرگونه تجزیه و تحلیل آماری بلامانع است. انجام تمام این فرایندها مستلزم مکاتبه و هماهنگی است.
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All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
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تمام متقاضیان می توانندبا آقای دکتر جعفرنژاد از طریق پست الکترونیکیdrsadegh2008@gmail.com تماس حاصل نمایند.
تمام متقاضیان می توانندبا آقای دکتر جعفرنژاد از طریق پست الکترونیکیdrsadegh2008@gmail.com تماس حاصل نمایند.
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Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant.
Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant.
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پس از مکاتبه یا تماس، به فاصله 10 روز کاری به درخواست شما پاسخ داده خواهد شد و داده ها به یک ایمیل معتبر که از سوی متقاضی معرفی می شود، ارسال می گردد.
پس از مکاتبه یا تماس، به فاصله 10 روز کاری به درخواست شما پاسخ داده خواهد شد و داده ها به یک ایمیل معتبر که از سوی متقاضی معرفی می شود، ارسال می گردد.
Protocol summary
Study aim
Determining the effect of Modified Intermittent Fasting Diet and Daily Calorie Restriction Diet on the severity of PMS and Quality of Life in women
Design
56 obese or overweight women are randomly assigned to one of the two control and intervention groups using a table of random numbers with the matching age and body mass index.
Settings and conduct
The study will be conducted at Kashan University of Medical Sciences.
Characteristics information, physical activity, Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, Insomnia Severity Index and anthropometric indices are filled in before and at the end of the trial. 2groups (n=28) of participants will receive a fasting or usual diet for 8 weeks. The intervention is a diet, there is no blinding.
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Participants/Inclusion and exclusion criteria
Inclusion criteria: Women in the age range of 18 to 50 years, Their BMI is more than or equal to 25 and less than 40
Exclusion criteria: Pregnancy, Breastfeeding, a history of any chronic diseases such as high blood pressure, heart disease, diabetes, gastrointestinal disorders such as gastritis, gastric and duodenal ulcers, The habit of smoking, alcohol abuse, Weight loss of 1 to 2 kg in the past month, following a specific diet or taking a specific medication, Taking dietary supplements, The unwillingness of the person to continue, Non-compliance with the regime offered to him, has gynecological diseases, History of abdominal and pelvic surgery, Suffering from severe stress and mental disorders during the study
Intervention groups
Intervention group: comprises one day of 75% caloric restriction and then ate 100% of his energy the next day. In the control group, subjects consumed 63% of their energy needs each day.
Main outcome variables
The severity of PMS ; Quality of Life; Body mass index; Free fat mass; Body fat mass; waist circumference; The waist-to-hip ratio
General information
Reason for update
Changing primary outcomes: increasing the number of primary outcomes
Changing the number of patients: increasing the number of patients
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054958N1
Registration date:2022-05-28, 1401/03/07
Registration timing:prospective
Last update:2022-10-26, 1401/08/04
Update count:4
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Saeedeh Hosseini hooshiar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9024
Email address
shoseinih3322@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-20, 1401/05/29
Expected recruitment end date
2022-12-15, 1401/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Modified Intermittent Fasting Diet and Daily Calorie Restriction Diet on the severity of PMS and Quality of Life in women
Public title
the effect of Modified Intermittent Fasting on PMS and Quality of Life in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age range of 18 to 50 years
Their body mass index is more than or equal to 25 and less than 40
has premenstrual syndrome
Lack of major mental disorder and depression
Regular menstrual cycle 21 to 35 days
Do not take contraceptives and antidepressants
Do not take a B6 supplement in the last 3 months
Exclusion criteria:
Pregnancy
Breastfeeding
a history of any chronic diseases such as high blood pressure, heart disease, diabetes, gastrointestinal disorders such as gastritis, gastric and duodenal ulcers
The habit of smoking
alcohol abuse
Weight loss of 1 to 2 kg in the past month
Following a specific diet or taking a specific medication
Taking dietary supplements
The unwillingness of the person to continue
Non-compliance with the regime offered to him
has gynecological diseases
History of abdominal and pelvic surgery
Suffering from severe stress and mental disorders during the study
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of individuals is done by convenient sampling. Participants are assigned by simple randomization and using the random numbers table to one of the two groups control and intervention. From the beginning, the odd number is assigned to the intervention group and the even number is assigned to the control group. Then for each participant, depending on whether we reach an even or odd number, we assign the patient to the intervention or control group. Randomization is individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine & Faculty Dentistry - Kashan University of Medical Sciences (Research Ethics Co
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.003
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the severity of PMS
Timepoint
Beginning and end of the study
Method of measurement
Calendar of Premenstrual syndrome Experiences (COPE)
2
Description
Quality of Life
Timepoint
Beginning and end of the study
Method of measurement
SF-12 questionnaire
3
Description
Body mass index
Timepoint
Beginning and end of the study
Method of measurement
Weight: scale, height: stadiometer
4
Description
Free fat mass
Timepoint
Beginning and end of the study
Method of measurement
Inbody device
5
Description
Body fat mass
Timepoint
Beginning and end of the study
Method of measurement
Inbody device
6
Description
waist circumference
Timepoint
Beginning and end of the study
Method of measurement
non-stretchable measuring tape
7
Description
The waist-to-hip ratio
Timepoint
Beginning and end of the study
Method of measurement
By dividing the waist circumference by the hip circumference
Secondary outcomes
1
Description
skeletal muscle mass
Timepoint
At the beginning and end of the study
Method of measurement
Inbody device
2
Description
percent body fat
Timepoint
At the beginning and end of the study
Method of measurement
Inbody device
3
Description
the hip circumference
Timepoint
At the beginning and end of the study
Method of measurement
non-stretchable measuring tape
4
Description
visceral fat area
Timepoint
At the beginning and end of the study
Method of measurement
Inbody device
Intervention groups
1
Description
Intervention group: Modified intermittent fasting comprises one day of 75% caloric restriction and then eating a diet that provides 100% of their energy needs on the next day and following this diet for 8 weeks. Participants' adherence to the diet is monitored every two weeks by taking food records from individuals.
Category
Prevention
2
Description
Control group: Subjects consume 63% of their energy requirement each day and follow this diet for 8 weeks. Participants' adherence to the diet is monitored every two weeks by taking food records from individuals.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini Hooshiar
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Kashan University of Medical Science
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Saeedeh Hosseini Hooshiar
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Science
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini Hooshiar
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan University of Medical Science
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini hooshiar
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan university of medical science
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The title of the data will be ‘’the effect of Modified intermittent Fasting Diet on the severity of Premenstrual Syndrome and Quality of Life ’’. All data can be shared after making participants anonymous.
When the data will become available and for how long
Six months after publishing results, everything will be accessible.
To whom data/document is available
The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
Under which criteria data/document could be used
With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination.
From where data/document is obtainable
All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
What processes are involved for a request to access data/document
Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant.