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The Effect of Yoghurt Fortified with Probiotics and Vitamins D and E on Anthropometric and Biochemical Indices, Blood Pressure, Sleep Quality, and Mental Health in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Controlled Clinical Trial

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History
# Registration date Revision Id
2 2023-12-16, 1402/09/25 288926
1 2023-12-14, 1402/09/23 288424
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  • Protocol summary

    1- Intervention group: 8 weeks of intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms), vitamin E (with a dose of 50 IU or 34 mg) and probiotics (Bifidobacterium animalis BB12 and Lactobacillus Acidophilus LA-5 in a dose of at least 10^7 CFU/gr) 2- Placebo group: 8 weeks of intaking120 grams per day of plain low-fat yogurt as a placebo
    1- Intervention group: 8 weeks of intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms), vitamin E (with a dose of 50 IU or 34 mg) and probiotics (Bifidobacterium animalis BB12 and Lactobacillus Acidophilus LA-5 in a dose of at least 10^6 CFU/gr) 2- Placebo group: 8 weeks of intaking120 grams per day of plain low-fat yogurt as a placebo
    1- گروه مداخله: 8 هفته دریافت 120 گرم در روز ماست کم چرب حاوی ویتامین D (با دوز 1000 IU یا 25 میکروگرم)، ویتامین E ( با دوز 50 IU یا 34 میلی گرم) و پروبیوتیک ( بفیدوباکتریوم انیمالیس بی بی 12 و لاکتوباسیلوس اسیدوفیلوس ال آ-5 در دوز حداقل 10^7 CFU/gr) ۲- گروه دارونما: 8 هفته دریافت 120گرم در روز ماست کم چرب ساده به عنوان دارونما
    1- گروه مداخله: 8 هفته دریافت 120 گرم در روز ماست کم چرب حاوی ویتامین D (با دوز 1000 IU یا 25 میکروگرم)، ویتامین E ( با دوز 50 IU یا 34 میلی گرم) و پروبیوتیک ( بفیدوباکتریوم انیمالیس بی بی 12 و لاکتوباسیلوس اسیدوفیلوس ال آ-5 در دوز حداقل 10^6 CFU/gr) ۲- گروه دارونما: 8 هفته دریافت 120گرم در روز ماست کم چرب ساده به عنوان دارونما

  • Intervention groups

    #1
    Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two probiotic strains of lactobacillus (Lactobacillus acidophilus LA5) and bifidobacterium (Bifidobacterium animalis BB12) at least 10^7 cfu/g for 8 weeks
    Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two probiotic strains of lactobacillus (Lactobacillus acidophilus LA5) and bifidobacterium (Bifidobacterium animalis BB12) at least 10^6 cfu/g for 8 weeks
    گروه مداخله: دریافت 120 گرم در روز ماست کم چرب حاوی ویتامین D (با دوزIU 1000 یا 25 میکروگرم) و ویتامین E (با دوز IU 50 یا 34 میلی گرم) و دو سویه پروبیوتیک لاکتوباسیلی (Lactobacillus acidophilus LA5) و بفیدوباکتریا (Bifidobacterium animalis BB12) به تعداد حداقل 10^7 cfu /g باکتری برای 8 هفته
    گروه مداخله: دریافت 120 گرم در روز ماست کم چرب حاوی ویتامین D (با دوزIU 1000 یا 25 میکروگرم) و ویتامین E (با دوز IU 50 یا 34 میلی گرم) و دو سویه پروبیوتیک لاکتوباسیلی (Lactobacillus acidophilus LA5) و بفیدوباکتریا (Bifidobacterium animalis BB12) به تعداد حداقل 10^6 cfu /g باکتری برای 8 هفته

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moein Askarpour
    Full name of responsible person - Persian: معین عسکرپور
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری تخصصی
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Razi Boulevard, Faculty of Nutrition and Food Sciences, Shiraz
    Street address - Persian: بلوار رازی، دانشکده تغذیه و علوم غذایی، شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 930 364 0250
    Fax:
    Email: askarpourmoein1994@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moein Askarpour
    Full name of responsible person - Persian: معین عسکرپور
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری تخصصی
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nutrition and Food Sciences, Razi Boulevard
    Street address - Persian: بلوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 930 364 0250
    Fax:
    Email: askarpourmoein1994@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Najmeh Hejazi
    Full name of responsible person - Persian: نجمه حجازی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Razi Boulevard, Faculty of Nutrition and Food Sciences, Shiraz
    Street address - Persian: شیراز، بلوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 917 702 0859
    Fax:
    Email: najmehhejazi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Najmeh Hejazi
    Full name of responsible person - Persian: نجمه حجازی
    Position - English: Associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nutrition and Food Sciences, Razi Boulevard
    Street address - Persian: بلوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 917 702 0859
    Fax:
    Email: najmehhejazi@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moein Askarpour
    Full name of responsible person - Persian: معین عسکرپور
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری تخصصی تغذیه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Razi Boulevard, Faculty of Nutrition and Food Sciences, Shiraz
    Street address - Persian: بلوار رازی، دانشکده تغذیه و علوم غذایی، شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 930 364 0250
    Fax:
    Email: askarpourmoein1994@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Moein Askarpour
    Full name of responsible person - Persian: معین عسکرپور
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری تخصصی تغذیه
    Latest degree: master
    Area of specialty/work: 34
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nutrition and Food Sciences, Razi Boulevard
    Street address - Persian: بلوار رازی، دانشکده تغذیه و علوم غذایی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1001
    Mobile: +98 930 364 0250
    Fax:
    Email: askarpourmoein1994@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of yogurt fortified with probiotics, vitamin D and vitamin E on anthropometric indices, biochemical indices, blood pressure, sleep quality and mental health in patients with polycystic ovary syndrome.
Design
This clinical trial is randomized, double-blind, placebo-controlled and parallel in phase 3, on 90 eligible people. Ninety people are allocated between two groups by block randomization method (45 people in each group).
Settings and conduct
Patients referred to Shiraz Mother and Child Hospital after knowing about the study, if they agree and obtain written and informed consent, are randomly assigned to 2 study groups (using the block randomization method). The participants receive the yogurts corresponding to their group, which are named in line with the names of the groups with letters A and B for the blinding of the participant and the researcher, and consume them daily before meals for 8 weeks. Evaluation of anthropometric and biochemical indicators, and completion of mental health and sleep quality questionnaires are done before and after the study.
Participants/Inclusion and exclusion criteria
Exclusion criteria: Women with polycystic ovary syndrome between the ages of 18 and 45 who are not breastfeeding or pregnant. Inclusion criteria: have no history of chronic diseases and have not taken antibiotics and nutritional supplements for 3 months before entering the study.
Intervention groups
1- Intervention group: 8 weeks of intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms), vitamin E (with a dose of 50 IU or 34 mg) and probiotics (Bifidobacterium animalis BB12 and Lactobacillus Acidophilus LA-5 in a dose of at least 10^6 CFU/gr) 2- Placebo group: 8 weeks of intaking120 grams per day of plain low-fat yogurt as a placebo
Main outcome variables
HOMA-IR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231210060323N1
Registration date: 2023-12-14, 1402/09/23
Registration timing: prospective

Last update: 2023-12-19, 1402/09/28
Update count: 1
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Moein Askarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
askarpourmoein1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Yoghurt Fortified with Probiotics and Vitamins D and E on Anthropometric and Biochemical Indices, Blood Pressure, Sleep Quality, and Mental Health in Patients with Polycystic Ovary Syndrome: A Randomized, Double-Blind, Controlled Clinical Trial
Public title
Effect of Yoghurt Fortified with Probiotics and Vitamins D and E in Treatment of Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate in the study and provide written consent Being in the reproductive age range of 18-45 years Diagnosis of polycystic ovary syndrome based on the Rotterdam criteria No intake of alcohol or drugs Not pregnant or breastfeeding No menopause No participate in other research studies
Exclusion criteria:
Using drugs affecting blood pressure, blood lipids, ovarian function, insulin sensitivity (including metformin, incretin, and Thiazolidinediones) and oral contraceptives (including progesterone and estrogen) since 3 months before entering the study. Taking any nutritional supplements for 3 months before entering the study Taking drugs affecting vitamin D metabolism having diabetes, thyroid disease or any systemic disease (such as kidney, liver, digestive system, cardiovascular system) Having disorders that lead to an increase in androgens in the blood (such as Cushing's syndrome, hyperprolactinemia)
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned using random blocks (ratio 1:1) for two groups (a control group and an intervention group). In this way, the double blocks will be created by someone outside the study. Then, a block is randomly selected to determine the assigned groups for the first two participants. In order to blind the researchers of this project, the assigned group will be placed in sealed envelopes by a person other than the researcher and a person outside the study, and in this way the allocation will be concealed. During the study, as each participant enters the study, according to the order, an envelope is opened and the assigned group is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the interventions, fortified yogurts (including two types of intervention yogurt and low-fat conventional yogurt) will be provided to people in deposable containers with the same color, smell, taste and appearance, which will be named with the letters A and B. The process of filling the yogurt containers and naming them will be done by someone outside the study, and the members of the research team and the participants of the different groups will be unaware of the type of intervention and the type of yogurt they received, so that the principles for blinding will be accomplished.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in research of the faculties of health, nutrition and food sciences-Shiraz Universi
Street address
Faculty of Health, Nutrition and Food Sciences, Razi Boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.104

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
Homeostasis model assessment of insulin resistance
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Formula

Secondary outcomes

1

Description
Weight
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Scale

2

Description
Body Mass Index
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Formula

3

Description
Waist Circumference
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Stadiometer

4

Description
Hip Circumference
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Stadiometer

5

Description
Waist to Hip Ratio
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Formula

6

Description
Systolic Blood Pressure
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Electronic Sphygmomanometer

7

Description
Diastolic Blood Pressure
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Electronic Sphygmomanometer

8

Description
Fasting Blood Sugar
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

9

Description
Fasting Insulin
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA Kit

10

Description
The Quantitative Insulin Sensitivity Check Index
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Formula

11

Description
Total Cholesterol
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

12

Description
Triglyceride
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

13

Description
Low-Density Lipoprotein Cholesterol
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

14

Description
High-Density Lipoprotein Cholesterol
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

15

Description
Total Testosterone
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA Kit

16

Description
Sex Hormone Binding Globulin
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA Kit

17

Description
Dehydroepiandrosterone Sulfate
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA Kit

18

Description
Luteinizing Hormone
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

19

Description
Follicle-Stimulating Hormone
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pars Azmoon Kit

20

Description
Free Androgen Index
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Formula

21

Description
High-Sensitivity C-Reactive Protein
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
ELISA Kit

22

Description
Malondialdehyde
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Spectrophotometry

23

Description
Total Antioxidant Capacity
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Spectrophotometry

24

Description
Mental Health
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
The Depression, Anxiety and Stress Scale - 21 Items Questioner

25

Description
Quality of Sleep
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Pittsburgh Sleep Quality Index

26

Description
Body Fat Percentage
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Body Composition Analyzer

27

Description
Skeletal Muscle Mass
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the start of the intervention)
Method of measurement
Body Composition Analyzer

Intervention groups

1

Description
Intervention group: Intaking120 grams per day of low-fat yogurt containing vitamin D (with a dose of 1000 IU or 25 micrograms) and vitamin E (with a dose of 50 IU or 34 mg) and two probiotic strains of lactobacillus (Lactobacillus acidophilus LA5) and bifidobacterium (Bifidobacterium animalis BB12) at least 10^6 cfu/g for 8 weeks
Category
Treatment - Other

2

Description
Control group: Intaking120 grams per day of conventional low-fat yogurt for 8 weeks as a placebo
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Ghadir Mother and Child Hospital, Infertility Clinic
Full name of responsible person
Bahia Namavar Jahromi
Street address
Imam Reza Boulevard, the beginning of Golshan town
City
Shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9701
Email
enghelab@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
najmehhejazi@gmail.com
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
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
Shiraz University of Medical Sciences
Full name of responsible person
Moein Askarpour
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Razi Boulevard
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1001
Email
askarpourmoein1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Hejazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Razi Boulevard
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1001
Email
najmehhejazi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Moein Askarpour
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Razi Boulevard
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1001
Email
askarpourmoein1994@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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