Protocol summary
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Study aim
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Determining 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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Design
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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.
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Settings and conduct
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The study will be conducted at Kashan University of Medical Sciences.
The physical activity, severity of PMS, health-related quality of life questionnaires are completed and anthropometric indices are evaluated before and after the study. 2groups 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
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Inclusion criteria: Women in the age range of 18 to 50 years, 25≤BMI˂40,menstrual bleeding lasting between 3 and 8 days, and normal menstrual cycles of 21–35 days, having PMS based on PSST.
Exclusion criteria: Pregnancy, breastfeeding, chronic diseases and gastrointestinal disorders, smoking, alcohol abuse, weight loss of 1 to 2 kg in the past month, following a specific diet or taking a specific medication in the last 2 months, taking dietary supplements to lose weight, psychiatric disorders and clinically diagnosed diseases, having surgery in the last 6 months, extreme stress during the trial, taking B6 supplements in the past 3 months, not completing the questionnaire for 3 successive days and 5 non-successive days
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Intervention groups
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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.
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Main outcome variables
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The severity of PMS ; health-related Quality of Life; Body mass index; Free fat mass; Body fat mass; waist circumference; The waist-to-hip ratio
General information
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Reason for update
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Correction of some parts of the protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220522054958N1
Registration date:
2022-05-28, 1401/03/07
Registration timing:
prospective
Last update:
2024-06-14, 1403/03/25
Update count:
4
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Registration date
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2022-05-28, 1401/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-20, 1401/05/29
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Expected recruitment end date
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2022-12-15, 1401/09/24
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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the effect of Modified Intermittent Fasting on PMS and Quality of Life in women
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
Menstrual bleeding lasting between 3 and 8 days, and normal menstrual cycles of 21–35 days
Having PMS based on PSST (premenstrual symptoms screening tool)
To comply with the study methods
Exclusion criteria:
Pregnancy
Breastfeeding
A history of any chronic diseases such as hypertension, heart disease, diabetes, gastrointestinal disorders such as gastritis, gastric and duodenal ulcers
The habit of smoking
Alcohol abuse
Weight loss of more than1 to 2 kg in the past month
Adherence to a special diet, and medication use in the last 2 months
Taking dietary supplements to lose weight
Mental or psychiatric disorders such as depression
Clinically diagnosed diseases such as infectious, cancer, kidney, CVD, liver, neurological, endocrine, and gynecological diseases
Having surgery in the last 6 months
Enduring extreme stress during the trial
Taking antidepressants and contraceptives
Taking B6 supplements in the past 3 months
Not completing the questionnaire for 3 successive days and 5 non-successive days
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals 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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-04-17, 1401/01/28
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1401.003
Health conditions studied
1
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Description of health condition studied
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premenstrual syndrome
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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the severity of PMS
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Timepoint
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Beginning and end of the study
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Method of measurement
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Calendar of Premenstrual syndrome Experiences (COPE)
2
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Description
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health-related Quality of Life
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Timepoint
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Beginning and end of the study
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Method of measurement
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SF-12 questionnaire
3
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Description
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Body mass index
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Timepoint
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Beginning and end of the study
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Method of measurement
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Weight: scale, height: stadiometer
4
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Description
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Free fat mass
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Timepoint
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Beginning and end of the study
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Method of measurement
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Inbody device
5
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Description
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Body fat mass
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Timepoint
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Beginning and end of the study
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Method of measurement
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Inbody device
6
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Description
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waist circumference
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Timepoint
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Beginning and end of the study
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Method of measurement
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non-stretchable measuring tape
7
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Description
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The waist-to-hip ratio
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Timepoint
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Beginning and end of the study
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Method of measurement
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By dividing the waist circumference by the hip circumference
Secondary outcomes
1
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Description
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skeletal muscle mass
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Inbody device
2
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Description
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percent body fat
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Inbody device
3
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Description
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the hip circumference
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Timepoint
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At the beginning and end of the study
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Method of measurement
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non-stretchable measuring tape
4
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Description
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visceral fat area
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Timepoint
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At the beginning and end of the study
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Method of measurement
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Inbody device
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Six months after publishing results, everything will be accessible.
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To whom data/document is available
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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
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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