This single-blind cross over randomized control trial is a study for measuring the effectiveness of soy bread diet on sevsral hormones levels in menopausal women with balanced diet. Inclusion criteria: women aged 45-55 years old; follicular stimulating hormone level greater than 40; having any surgical ill; absence history of gynecological cancers; lake history of hormone replacement thrapy or use the supplements in the recent 3 mounth;using usuale diets and lack of history for allergic reaction to soy and lake history of oophorectomy, Exclusion criteria: catchinig surgical ills or abnormal vaginal bleeding; reaction to soy diet and unwillingness to continue working. In this study 60 menopausal women were divided randomly in two groups (A,B) of 30 and hormonal tests (estradiol, sex-hormone-binding globulin, luteinizing hormone, follicular hormone) were done for two groups and then groupA received one soy bread diet daily and group B were used their usual diet for 8 weeks. Then two groups were done same tests and then group B received one soy bread daily and group A were used usual diet for 8 weeks. In the end of 8 weeks two group were done same hormonal tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050513237N1
Registration date:2013-05-16, 1392/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-16, 1392/02/26
Registrant information
Name
Fatemeh Bozorgannia
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1783 7914
Email address
bozorganf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of soy diet on some of sex hormons in menopausal weman with balanced diet.
Public title
The effects of soy diet on sex hormones
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women aged 45-55 years old; follicular stimulating hormone level greater than 40; having any surgical ill; absence history of gynecological cancers; lake history of hormone replacement thrapy or use the supplements in the recent 3 mounth;using usuale diets and lack of history for allergic reaction to soy and lake history of oophorectomy, Exclusion criteria: catchinig surgical ills or abnormal vaginal bleeding; reaction to soy diet and unwillingness to continue working.
Age
From 45 years old to 55 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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Shiraz University of Medical Sciences
Street address
Research Deputy, Shiraz University of Medical Science
City
Shiraz
Postal code
Approval date
2012-06-28, 1391/04/08
Ethics committee reference number
ct-91-6085
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Estradiol
Timepoint
Initial of study, after 8 weeks, at the end of the syudy
Method of measurement
ELIZA
2
Description
SHBG
Timepoint
Initial of study, after 8 weeks, at the end of the syudy
Method of measurement
ELIZA
3
Description
FSH
Timepoint
Initial of study, after 8 weeks, at the end of the syudy
Method of measurement
ELIZA
4
Description
LH
Timepoint
Initial of study, after 8 weeks, at the end of the syudy.
Method of measurement
ELIZA
Secondary outcomes
empty
Intervention groups
1
Description
B group performed hormonal tests, then used their usual diets and again performed same tests then received one soy bread daily for 8 weeks and in the end performed same testes.
Category
Other
2
Description
Group A performed hormonal tests, then received one soy bread daily for 8 weeks and again performed same tests and then used their usual diet and in the end performed same testes. .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahary hospital
Full name of responsible person
Fatemeh Bozorgannia
Street address
Quran Gate, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Technology and Research Office, Research Deputy , Shiraz University of Medical Science, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadigheh Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1242 4128
Fax
Email
Forouharism@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadigheh Forouhari
Position
Master of Midwifery , Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1242 4128
Fax
Email
Forouharism@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz College Of Nursing Midwifery
Full name of responsible person
Sadighe Forouhari
Position
Master Of Midwifery, Guide Master
Other areas of specialty/work
Street address
College Of Nursing Midwifery, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1242 4128
Fax
Email
Forouharism@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)