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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

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History
# Registration date Revision Id
5 2024-06-12, 1403/03/23 305005
4 2022-10-25, 1401/08/03 243858
3 2022-07-30, 1401/05/08 235455
2 2022-07-06, 1401/04/15 232794
1 2022-05-28, 1401/03/07 227839
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  • Protocol summary

    تعداد 56 نفر خانم چاق و یا دارای اضافه وزن به صورت کاملا تصادفي و به وسیله جدول اعداد تصادفی با یکسان سازی از لحاظ سن و نمایه توده بدنی در يكي از دو گروه کنترل و مداخله قرار داده می شوند.
    تعداد60 نفر خانم چاق و یا دارای اضافه وزن به صورت کاملا تصادفي و به وسیله جدول اعداد تصادفی با یکسان سازی از لحاظ سن و نمایه توده بدنی در يكي از دو گروه کنترل و مداخله قرار داده می شوند.
    معیارهای ورود به مطالعه: خانمها در محدوده سنی18 تا 50 سال، نمایه توده بدنی آنها بیشتر یا مساوی 25 و کمتر از 40 ، دارای سندروم پیش از قاعدگی، فقدان بیماری روانی و افسردگی اساسی ، منظم بودن سیکل قاعدگی 21 تا 35 روز ، عدم مصرف داروهای ضد بارداری و ضد افسردگی، عدم مصرف مکمل B6 در 3 ماه اخیر. معیارهای خروج از مطالعه: بارداری، شیردهی، ابتلا به بیماری های مزمن مثل فشار خون، بیماری های قلبی، دیابت و بیماریهای گوارشی،عادت به کشیدن سیگار، اعتیاد به مصرف الکل ، کاهش وزن 1 تا 2 کیلوگرم در یک ماه گذشته ،پیروی از رژیم خاص و یا مصرف داروی خاص، مصرف مکمل رژیمی، عدم تمایل فرد برای ادامه همکاری، عدم تبعیت از رژیم ارائه شده به فرد، ابتلا به بیماري هاي زنان، سابقه جراحی شکم و لگن، ابتلا به تنش و بحرانهای روحی و روانی شدید در طول مطالعه
    معیارهای ورود به مطالعه: خانمها در محدوده سنی18 تا 50 سال، نمایه توده بدنی آنها بیشتر یا مساوی 25 و کمتر از 40 ، دارای سندروم پیش از قاعدگی، فقدان بیماری روانی و افسردگی اساسی ، منظم بودن سیکل قاعدگی 21 تا 35 روز ، عدم مصرف داروهای ضد بارداری و ضد افسردگی، عدم مصرف مکمل B6 در 3 ماه اخیر. معیارهای خروج : بارداری، شیردهی، ابتلا به بیماری های مزمن مثل فشار خون، بیماری های قلبی، دیابت و بیماریهای گوارشی،عادت به کشیدن سیگار، اعتیاد به مصرف الکل ، کاهش وزن 1 تا 2 کیلوگرم در یک ماه گذشته ،پیروی از رژیم خاص و یا مصرف داروی خاص، مصرف مکمل رژیمی، عدم تمایل فرد برای ادامه همکاری، عدم تبعیت از رژیم ارائه شده به فرد، ابتلا به بیماري هاي زنان، سابقه جراحی شکم و لگن، ابتلا به تنش و بحرانهای روحی و روانی شدید در طول مطالعه
    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. Daily dietary carbohydrates, fat and protein accounted for 55, 30 and 15% of ingested energy, respectively.
    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.
    گروه مداخله: فستینگ متناوب اصلاح شده شامل یک روز محدودیت کالری 75 درصدی و سپس دریافت 100 درصد انرژی مورد نیاز در روز بعد میباشد. در گروه کنترل، افراد روزانه 63 درصد انرژی مورد نیاز خود را مصرف می کردند. کربوهیدرات، چربی و پروتئین رژیم غذایی روزانه به ترتیب 55، 30 و 15 درصد از انرژی دریافتی را تشکیل می دهند.
    گروه مداخله: فستینگ متناوب اصلاح شده شامل یک روز محدودیت کالری 75 درصدی و سپس دریافت 100 درصد انرژی مورد نیاز در روز بعد میباشد. در گروه کنترل، افراد روزانه 63 درصد انرژی مورد نیاز خود را مصرف می کردند.
    The severity of PMS ; Quality of Life
    The severity of PMS ; Quality of Life; Body mass index; Free fat mass; Body fat mass; waist circumference; The waist-to-hip ratio
    شدت علائم قبل از قاعدگي; کیفیت زندگی
    شدت علائم قبل از قاعدگي; کیفیت زندگی; نمایه توده بدنی; توده بدون چربی; توده چربی بدن; دور کمر; نسبت دور کمر به دور باسن

  • General information

    56
    60
    empty
    Changing primary outcomes: increasing the number of primary outcomes Changing the number of patients: increasing the number of patients
    empty
    تغییر پیامدهای اولیه: افزایش تعداد پیامدهای اولیه تغییر تعداد بیماران: افزایش تعداد بیماران

  • Primary outcomes

    #1
    empty
    Body mass index
    empty
    نمایه توده بدنی
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Weight: scale, height: stadiometer
    empty
    وزن:ترازو، قد: قدسنج
    #2
    empty
    Free fat mass
    empty
    توده بدون چربی
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Inbody device
    empty
    دستگاه Inbody
    #3
    empty
    Body fat mass
    empty
    توده چربی بدن
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Inbody device
    empty
    دستگاه Inbody
    #4
    empty
    waist circumference
    empty
    دور کمر
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    non-stretchable measuring tape
    empty
    متر نواری غیر قابل ارتجاع
    #5
    empty
    The waist-to-hip ratio
    empty
    نسبت دور کمر به دور باسن
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    By dividing the waist circumference by the hip circumference
    empty
    با تقسیم دور کمر به دور باسن

  • Secondary outcomes

    #1
    BMI
    skeletal muscle mass
    نمایه توده بدنی
    توده ماهیچه ای اسکلتی
    Beginning and end of the study
    At the beginning and end of the study
    ابتدا و انتهای مطالعه
    در شروع و پایان مطالعه
    Weight (scales); Height(Stadiometer)
    Inbody device
    وزن(ترازو); قد (قدسنج)
    دستگاه Inbody
    #2
    Waist circumference
    percent body fat
    دور کمر
    درصد چربی بدن
    Beginning and end of the study
    At the beginning and end of the study
    ابتدا و انتهای مطالعه
    در شروع و پایان مطالعه
    a non-stretchable measuring tape
    Inbody device
    متر نواری غیر قابل ارتجاع
    دستگاه Inbody
    #3
    Fat free mass
    the hip circumference
    توده بدون چربی بدن
    دور باسن
    Beginning and end of the study
    At the beginning and end of the study
    ابتدا و انتهای مطالعه
    در شروع و پایان مطالعه
    Inbody
    non-stretchable measuring tape
    دستگاه Inbody
    متر نواری غیر قابل ارتجاع
    #4
    Body fat mass
    visceral fat area
    توده چربی بدن
    محدوده چربی احشایی
    Beginning and end of the study
    At the beginning and end of the study
    ابتدا و انتهای مطالعه
    در شروع و پایان مطالعه
    Inbody
    Inbody device

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. .
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: 2022-07-08, 1401/04/17
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
2022-06-10, 1401/03/20
Expected recruitment end date
2022-06-20, 1401/03/30
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

empty

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)
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
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