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Study of the effect of high protein-low carbohydrate weight loss diet with fennel supplement on androgens and anthropometric indices in overweight and obese women with polycystic ovary syndrome

Protocol summary

Study aim
The aim of this study was to evaluate the effects of high-protein- low carbohydrates weight loss diet with fennel supplement on anthropometric factors, androgens in obese and overweight patients with polycystic ovary syndrome
Design
In this study,64 patients are chosen who have inclusion criteria. participant were randomly allocated to four intervention groups and given code to each of theme.
Settings and conduct
A randomized double-blind clinical trial was conducted in obese and overweight patients with a polycystic ovary syndrome who referred to Imam Ali and a diabetes clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria for the study, including polycystic ovary syndrome based on Rotterdam criteria and being overweight or obese (BMI greater than or equal to 25), 18-45 ages and willing to participate in this study; Exclusion criteria of this study are other causes of hyper androgenism and people with severe hirsutism, acne or severe hair loss, and history of hypersensitivity to fennel or any of its compounds. , Pregnancy and those who tend to be pregnant, have allergic asthma, seizures, liver and kidney disease (urea and creatinine above normal range), or cancer.
Intervention groups
The first group received high protein-low-carbohydrate weight loss diet with fennel capsule, the second group received high protein-low-carbohydrate weight loss diet with placebo, the third group received Standard weight loss diet with fennel capsule and fourth group received Standard weight loss diet with placebo
Main outcome variables
Total testosteron, SHBG,Weight,waist circumference,hip circumference

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120913010826N28
Registration date: 2018-04-07, 1397/01/18
Registration timing: registered_while_recruiting

Last update: 2018-04-07, 1397/01/18
Update count: 0
Registration date
2018-04-07, 1397/01/18
Registrant information
Name
Azadeh Nadjarzadeh
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 202 2817
Email address
azadnajarzadeh@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-10-21, 1397/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of high protein-low carbohydrate weight loss diet with fennel supplement on androgens and anthropometric indices in overweight and obese women with polycystic ovary syndrome
Public title
Effect of high protein-low carbohydrate weight loss diet with fennel supplement in women with polycystic ovary syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
polycystic ovary syndrome based on the Rotterdam criteria, at least two criteria of the three following criteria: 1) anovulation or oligo- ovulation or menstrual cycle less than 6 times in 12 months. 2) Clinical or biochemical increase in androgens, including the presence of acne, hirsutism, alopecia or serum levels of androgens . 3) Polycystic view with 12 or more follicles in each ovary with a diameter of between 3-2Myly meters or ovarian volume increased more than 11 cm overweight or obese (BMI greater than or equal to 25) aged 18-45 years willing to participate in this study
Exclusion criteria:
The other causes of hyperandrogenism، Congenital adrenal hyperplasia، Cushing, hypothyroidism, hyperprolactinemia, and Androgen-secreting tumors and those with hirsutism, acne or severe hair loss Allergy to anise or any of its components pregnant women and people who desire to pregnancy allergic asthma seizures liver and renal (urea and creatinine above the normal range) disease cancer
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were randomly assigned to four intervention groups using a randomized table: 1-high proteine- low carohydrate diet weight loss diet with fennel, 2-high proteine- low carohydrate diet weight loss diet with placebo 3-standard weight loss diet with fennel, 4-standard weight loss diet with placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prescribing supplement and placebo by a researcher without knowledge of its type, as well as taking it by the participants in the study without their knowledge. There is no possibility of blindness for the diet.In order to minimize bias in the intervention, one researcher randomly assigns random access to the patient in a randomized manner, without any knowledge of the patient's condition, and the other investigator who is associated with the patient, will place that person in the designated group.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd university of Medical Sciences
Street address
Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
ir.ssu.sph.rec.1396.88

2

Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Sciences
Street address
آدرس خیابان Campus of Sadoughi University of Medical Sciences, Shohadaye Gomnam Blv,Yazd
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
ir.ssu.sph.rec.1396.88

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Total Testosterone
Timepoint
befor and after 12 weeks treatment
Method of measurement
Using ELISA

2

Description
SHBG(Sex hormone-binding globulin)
Timepoint
befor and after 12 weeks treatment
Method of measurement
Using ELISA

3

Description
weight
Timepoint
befor and after 12 weeks treatment
Method of measurement
Scale

4

Description
waist circumference
Timepoint
befor and after 12 weeks treatment
Method of measurement
Meter

5

Description
hip circumfernce
Timepoint
befor and after 12 weeks treatment
Method of measurement
Meter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Prescribe high protein- low carbohydrate weight loss diet with 2 fennel capsule per day
Category
Treatment - Drugs

2

Description
Intervention group 2: prescribe high protein-low carbohydrate weight loss diet with 2 placebo capsule per day
Category
Placebo

3

Description
Control group 1: prescribe Standard weight loss diet (The amount of energy needed by each individual will be calculated using an ideal weight of BMI 22 to 23 kg / m2, and 500 calories will be deducted from the total energy required with 2 fennel capsule per day.
Category
Treatment - Drugs

4

Description
Control group 2: prescribe Standard weight loss diet with 2 pelacebo capsul per day
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Dr.Azadeh Nadjarzadeh
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadnajarzadeh@ssu.ac.ir

2

Recruitment center
Name of recruitment center
diabetes clinic
Full name of responsible person
Dr.Azadeh Najarzadeh
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
azadnajarzadeh@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Hoshangh Mehrparvar
Street address
یزد،میدان باهنر ،دانشگاه علوم پزشکی شهید صدوقی یزد
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3149 2239
Email
azadehnajarzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
دانشگاه علوم پزشکی یزد
Full name of responsible person
Elham Hosseini Marnani
Position
Master Student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
Email
Elham_Hosseini1993@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Azadeh Nadjarzadeh
Position
Associate Professor, nutrition specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health,shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Fax
Email
azadehnajarzadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
yazd university of medical sciences
Full name of responsible person
Elham_Hosseini1993@yahoo.com
Position
Master Student of Health Sciences in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of nutrition, school of public health, shahid sadoughi university of medical sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
Elham_Hosseini1993@yahoo.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Data report will be shared after publishing the paper.
When the data will become available and for how long
Six months after publish
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Using for Meta-analysis
From where data/document is obtainable
Center nutrition, public health, univercity of medical sciencies yazd Tel: 009835 31492239 Email: azadehnajarzadeh@gmail.com Azadenadjarzadeh
What processes are involved for a request to access data/document
It will be sent two weeks after the receipt of the email with the consent of the co-workers
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