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The effect of diet enriched with whole grains and grains with bran on severity of premenstrual syndrome symptoms in nurses

Protocol summary

Summary
The aim of this study was to investigate the effect of diet enriched with whole grains and grains with bran on the severity of symptoms of premenstrual syndrome in nurses as a randomized controlled clinical trial on 100 nurses with premenstrual syndrome. Inclusion criteria include ages 18 to 45, regular menstruation cycles of 21 to 35 days, bleeding times of 3 to 8 days, and exclusion criteria, including diseases and interventions that affect PMS symptoms, use Of hormones and antidepressant drugs, regular exercise, BMI of over 39, alcoholics and smokers, the death of close relatives over the past six months. According to these criteria, nurses will be assigned to two groups of intervention and control groups. Individuals in the intervention group will change their daily cereals to whole grains and grains with bran for a period of three months, and in order to provide at least four serving of whole grains daily, one loaf of 120 volumes of lavax bread will be provided free of charge, And individual in the control group will continue to have regular cereals in their diet. Finally, by comparing the mean scores obtained before and after the intervention, the effectiveness of this method will be determined by the number of servings eaten.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031132417N3
Registration date: 2017-10-17, 1396/07/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-17, 1396/07/25
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 2375
Email address
alizadeh.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Scince
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diet enriched with whole grains and grains with bran on severity of premenstrual syndrome symptoms in nurses
Public title
The effect of diet enriched with whole grains and grains with bran on severity of premenstrual syndrome symptoms in nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18 to 30 years old, having regular menstrual cycles of 21–35 days, bleeding for 3 to 8 days, having a depression score of 0 to 16 based on beck depression inventory. Exclusion criteria: Having diseases and interventions that affect PMS symptoms, using hormones, using antidepressants and contraceptives drugs, treated with acupuncture, homeopathy and other complementary therapies, following a weight loss diet, exercising regularly, BMI over the 39, drinking alcohol, smoking, death of close relatives and having stressful events in the last month, undergoing surgical operation in the last 6 months, breast feeding and pregnancy.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urmia University of Medical Science
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
5714783734
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
ir.umsu.rec.1395.256

Health conditions studied

1

Description of health condition studied
Pre Menstrual Syndrome
ICD-10 code
F99
ICD-10 code description
not otherwise specified

Primary outcomes

1

Description
Severity of behavioral symptoms
Timepoint
Before intervention and at intervals of 1,2 and 3 months after intervention
Method of measurement
Evaluation of the questionnaire

2

Description
Severity of emotional symptoms
Timepoint
Before intervention and at intervals of 1,2 and 3 months after intervention
Method of measurement
Evaluation of the questionnaire

3

Description
Severity of physical symptoms
Timepoint
Before intervention and at intervals of 1,2 and 3 months after intervention
Method of measurement
Evaluation of the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In this study, people in the intervention group after become aware of foods that are considered as whole grains,for 3 months will change their daily intake of cereals from refined grain to whole grains or grains with bran. in order to provide at least four serving of whole grains, one loaf of 120 volumes of lavax bread is given free of charge to them daily And they will be asked to not change their physical activity during this time
Category
Other

2

Description
In this study, individuals in the control group were asked to take their usual daily intake of cereals for 3 months and not to change their physical activity.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Street address
Ershad Blvd,Ayatollah Modarres Blvd, Urmia
City
Urmia

2

Recruitment center
Name of recruitment center
Motahari Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
opposite the 15th Street, Kashani Street, Urmia
City
Urmia

3

Recruitment center
Name of recruitment center
Taleghani Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
opposite Takht-e Sport Complex, Kashani Street, Urmia
City
Urmia

4

Recruitment center
Name of recruitment center
Urmia Seyyed Al-Shohada Hospital
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Opposite Samadzadeh Street, 17 Shahrivar Blvd, Urmia
City
Urmia

5

Recruitment center
Name of recruitment center
Razi Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Junction of Agriculture Jihad, Salmas Road, Urmia
City
Urmia

6

Recruitment center
Name of recruitment center
Azarbaijan Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Above Azad University, Shahid Beheshti Street, Urmia
City
Urmia

7

Recruitment center
Name of recruitment center
Imam Reza Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Imam Reza Street, Molavi Street, Urmia
City
Urmia

8

Recruitment center
Name of recruitment center
Shafa Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Imam Street, Urmia
City
Urmia

9

Recruitment center
Name of recruitment center
Dr Solatii Hospital, Urmia
Full name of responsible person
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Pr
Street address
Plaque 602, Imam Street, Urmia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Urmia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3275 2375
Fax
+98 44 3278 0801
Email
alizadeh.m@umsu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Science
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Specialty Doctorte Degree in Nutritioal Science/ Urmia University of Medical Sciences Associate Prof
Other areas of specialty/work
Street address
Nutrition Department, Faculty of Medicine, College of Medicine, Urmia University of Medical Science, 11th km of Nazloo Road, Urmia
City
Urmia
Postal code
Phone
+98 44 3275 2375
Fax
+98 44 3278 0801
Email
alizadeh.m@umsu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Science
Full name of responsible person
Mozhgan Esmaeilpour
Position
MS Student of nutrition
Other areas of specialty/work
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Postal code
Phone
+98 44 3223 4897
Fax
Email
Web page address
http://www.umsu.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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