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The effect of high-fiber, low-calorie balanced diet on some factors in obese or overweight hirsute women with pco

Protocol summary

Summary
Object of This study is investigate the effect of low calorie high fiber diet on some factors in obese or overweight hirsute women and Pco . This study is based on a not blind randomized clinical trial that perform on 50 hirsute women with this inclusion criteria ( Hirsutism or Pco confirmed by a physician; lack of food or certain medications; lack of gastrointestinal disease; hepatic, metabolic, cardiovascular, renal,…; women ages 18-45; not pregnant; not lactating; non-smoking; non-hormonal drugs in the past three months; patients treated with the same way). The population of eligible women is divided into two groups, A and B, each of which consists of 25 patients using Randomized block permutation. Women are well aware that they are divided randomly In an intervention or control group. The 24-hour dietary recall questionnaire and demographic information completed by researcher. 10 cc blood sample will be taken for the measurement of total lipid, cholesterol, triglycerid, insulin, prolactin, FBS on days 3-5 of the menstrual period, Before and one month after the completion of intervention .Time of the intervention is 3 month and The intervention including the use of high-fiber and low-calorie diet or a normal diet . During the intervention, the researcher follow the people by telephone or person visit And the results of study will be analyzed . Exclusion criteria: medical problems during the study; unwillingness to cooperate; pregnancy; Gastrointestinal problems when using a high-fiber diet

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014101918187N3
Registration date: 2014-12-07, 1393/09/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Sedighe Forouhari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 987136474257
Email address
foruharis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-fiber, low-calorie balanced diet on some factors in obese or overweight hirsute women with pco
Public title
The effect of high –fiber diet on hirsutism and Pco
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hirsutism or Pco confirmed by a physician; lack of food or certain medications; lack of gastrointestinal disease, hepatic, metabolic, cardiovascular, renal, women ages 18-45; not pregnant; not lactating; non-smoking; non-hormonal drugs in the past three months; patients treated with the same way; exclusion criteria: medical problems during the study; unwillingness to cooperate; pregnancy; gasterointestinal problems when using a high-fiber diet
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by block permutation

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University Of Medical Sciences, vice chancellor for research of Shiraz Un
Street address
Zand street , Shiraz , central building of Shiraz University of Medical Sciences
City
Shiraz
Postal code
71345-1978
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
7751-9371

Health conditions studied

1

Description of health condition studied
Hirsutism
ICD-10 code
L68.0
ICD-10 code description
Hirsutism

2

Description of health condition studied
poly cystic ovarian syndrom
ICD-10 code
E28.2
ICD-10 code description
poly cystic ovarian syndrom

Primary outcomes

1

Description
Total Lipid
Timepoint
before the intervention and one month after the completion of intervention
Method of measurement
laboratory

2

Description
cholesterol
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Lab data

3

Description
Triglycerid
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Lab data

4

Description
Insulin
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Lab data

5

Description
prolactin
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Lab data

6

Description
FBS
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Lab data

Secondary outcomes

1

Description
Body mass index
Timepoint
Before the intervention and one month after the completion of intervention
Method of measurement
Kg/m2

Intervention groups

1

Description
intervention group : high-fiber, low-caloric balance diet ,for 3 month The list of high fiber diet have been give to people
Category
Lifestyle

2

Description
Control group(normal diet without any changing ,for 3 month)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid motahari clinic
Full name of responsible person
korouni Atefe, Studend of Msc in Midwifery
Street address
Namazi square, Zand street , Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Shahid Faghihi clinic
Full name of responsible person
korouni Atefe, Studend of Msc in Midwifery
Street address
adjucent to University of Medical Sciences, Zand street, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shiraz University Of Medical Science
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences ,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
Vice chancellor for research of Shiraz University Of Medical Science
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 University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shiraz University of Medical Science، Zand street
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3227 9715
Fax
+98 71 3647 4252
Email
foruharis@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Forouhari
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shiraz University of Medical Science , Zand Street
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3227 9715
Fax
+98 71 3647 4252
Email
foruharis@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara kharati
Position
authority of infertility research center
Other areas of specialty/work
Street address
Shiraz University of Medical Science ، Zand Street
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3227 9715
Fax
+98 71 3647 4252
Email
s.kharati@yahoo.com
Web page address

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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