Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2022-06-10, 1401/03/20
2022-08-20, 1401/05/29
2022-0608-1020 00:00:00
2022-06-20, 1401/03/30
2022-12-15, 1401/09/24
2022-0612-2015 00:00:00
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:2022-08-02, 1401/05/11
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
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