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The effect of low free sugar diet on anthropometric parameters, lipid profile and glycemic control in women with polycystic ovarian syndrome

Protocol summary

Study aim
the effects of free sugar restricted diet on anthropometric parameters, lipid profile, glycemic control in women with polycystic ovary syndrome
Design
A clinical trial with a control group on 74 women with polycystic ovary syndrome (PCOS) randomized by Stratified Blocked Randomization.
Settings and conduct
Patients with PCOS referred to the women's clinic of Valiasr Hospital, who meet the inclusion criteria . After obtaining written consent, they will enter the study, they will be randomly divided into the group receiving the diet with low free sugar and the normal diet group along with nutritional recommendations for 12 weeks. At the beginning and end of the study, the anthropometric parameters will be measured and 5 cc of blood is taken from them after 10 to 12 hours of fasting.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with polycystic ovary syndrome according to the Rotterdam criteria, aged 18 and 45 years, less than 6 months have passed since the diagnosis of the disease, and more than 10% of their daily calories are from free sugars. Exclusion criteria: pregnancy and breastfeeding, following special diets or weight loss diets in the last three months, taking hormonal drugs, corticosteroids, omega-3 and spironolactone, suffering from uterine and ovarian cancers, liver diseases, suffering from kidney failure. and heart failure, infectious or inflammatory diseases, thyroid gland disorders, diabetes, hyperprolactinemia unwillingness to cooperate
Intervention groups
Patients in the intervention group (37 people) eat a diet with less than 3% of free sugar calories and in the control group (37 people) follow their usual diet along with dietary recommendations for 12 weeks.
Main outcome variables
fasting blood glucose (FBG) Serum insulin HOMA-IR QUICK lipid profile Anthropometric parameters

General information

Reason for update
Acronym
-
IRCT registration information
IRCT registration number: IRCT20230615058489N1
Registration date: 2023-06-25, 1402/04/04
Registration timing: prospective

Last update: 2023-06-25, 1402/04/04
Update count: 0
Registration date
2023-06-25, 1402/04/04
Registrant information
Name
Hajar Gholamshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5531 2098
Email address
hajar.gholamshahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low free sugar diet on anthropometric parameters, lipid profile and glycemic control in women with polycystic ovarian syndrome
Public title
the effect of low free sugar diet in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
willingness to participate in research Age 18-45 years BMI> 25 Having polycystic ovarian syndrom based on the diagnosis of gynecologist ( According to Rotterdom criteria) Less than 6 months have passed since diagnosis People who get more than 10% of their calories from free sugars Absence of other diseases and chronic and acute disorders of women such as uterine and ovarian cancers Not suffering from liver diseases, suffering from kidney failure and heart failure, suffering from infectious or inflammatory diseases, suffering from thyroid gland disorders, diabetes, types of cancer, hyperprolactinemia Not pregnant or breastfeeding Non-adherence to special diets or weight loss diets in the last three months Not using hormonal drugs, corticosteroids, omega-3 and spironolactone
Exclusion criteria:
Unwillingness to continue cooperation Failure to follow the intervention diet for more than 2 days Starting a new diet other than the nutritional recommendations provided in the control group pregnancy Changing the medication regimen, physical activity during the intervention period
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: 74
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign patients to two groups, stratified blocked randomization method is used based on BMI (overweight or obese). The size of the blocks is 4 blocks, two allocations to the intervention group (A) and two allocations to the control group (B) are considered. 6 permutations including AABB, ABAB, BBAA, BABA, ABBA, BAAB will be created. Finally, these permutations will be used for both BMI blocks.
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
Research ethic committee Islamic Azad University_ Science and research Branch
Street address
Science and Research Branch, Daneshgah Blvd,Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2023-06-10, 1402/03/20
Ethics committee reference number
IR.IAU.SRB.REC.1402.041

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
Fasting Blood Glucose (FBG)
Timepoint
Beggining and after 12 weeks
Method of measurement
Enzymatic method

2

Description
serum insulin
Timepoint
Beggining and after 12 weeks
Method of measurement
ELISA

3

Description
HOMA-IR
Timepoint
Beggining and after 12 weeks
Method of measurement
Calculate

4

Description
QUICKI
Timepoint
Beggining and after 12 weeks
Method of measurement
calculate

5

Description
Serum triglycerides
Timepoint
Beggining and after 12 weeks
Method of measurement
Enzymatic Method

6

Description
Total serum cholesterol
Timepoint
Beggining and after 12 weeks
Method of measurement
Enzymatic Method

7

Description
Serum LDL-C
Timepoint
Beggining and after 12 weeks
Method of measurement
Enzymatic Method

8

Description
Serum HDL-C
Timepoint
Beginning and after 12 weeks
Method of measurement
Enzymatic Method

9

Description
Weight
Timepoint
Beginning and after 12 weeks
Method of measurement
Scales

10

Description
Body Mass Index
Timepoint
Beginning and after 12 weeks
Method of measurement
Calculate

11

Description
Waist to hip ratio
Timepoint
Beginning and after 12 weeks
Method of measurement
Calculate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 12 weeks, the low free sugar diet (less than 3% of calories are from free sugar) is provided along with the recommendations of a healthy diet and physical activity, and in order to follow the program, a food record is recorded every 2 weeks through A phone call is made.
Category
Treatment - Other

2

Description
Control group: food and physical activity recommendations / 12 weeks
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital Women's Clinic
Full name of responsible person
Hajar GHolamshahi
Street address
Valiasr Hospital, Valiasr Ave,Above Mirdamad Blvd Tehran
City
Tehran
Province
Tehran
Postal code
19967
Phone
+98 21 8123 5000
Email
hajar.gholamshahi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asal Ataie Jafari
Street address
Research and Science Branch,Daneshgah Blvd, Simun bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
asal_ataie2003@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Asal Ataie Jafari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Research and Science Branch, Daneshgah Blvd, Simun Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
asal_ataie2003@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hajar Gholamshahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Unit 212, Dastwara Residential Complex, No. 185, Dastwara Blvd., after Godarzi Alley, South Aliabad, Tehran
City
Tehran
Province
Tehran
Postal code
1838871936
Phone
+98 21 5531 2098
Email
hajar.gholamshahi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hajar Gholamshahi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Unit 212, Dastwara Residential Complex, No. 185, Dastwara Blvd., after Godarzi Alley, South Aliabad, Tehran
City
Tehran
Province
Tehran
Postal code
1838871936
Phone
+98 21 5531 2098
Email
hajar.gholamshahi@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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