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The effects of fortified-bread with pomegranate peel powder on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, mood and inflammation level in patients with type 2 diabetes

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History
# Registration date Revision Id
2 2022-11-08, 1401/08/17 245258
1 2020-09-21, 1399/06/31 151753
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  • Primary outcomes

    #1
    ٍEffect of fortified-bread with pomegranate peel powder on cholesterol level
    ٍEffect of fortified-bread with pomegranate peel powder on FBS level
    بررسی تاثیر نان غنی شده با پوست انار بر سطح کلسترول
    بررسی تاثیر نان غنی شده با پوست انار بر سطح قند ناشتا
    #2
    empty
    ٍEffect of fortified-bread with pomegranate peel powder on HbA1c level
    empty
    بررسی تاثیر نان غنی شده با پوست انار بر سطح هموگلوبین گلیکوزیله
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by chromatography
    empty
    اندازه گیری توسط کروماتوگرافی
    #3
    empty
    ٍEffect of fortified-bread with pomegranate peel powder on insulin level
    empty
    بررسی تاثیر نان غنی شده با پوست انار بر سطح انسولین
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by laboratory kit
    empty
    اندازه گیری توسط کیت آزمایشگاهی
    #4
    empty
    ٍEffect of fortified-bread with pomegranate peel powder on lipid profile level
    empty
    بررسی تاثیر نان غنی شده با پوست انار بر سطح چربی های خون
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by laboratory kit
    empty
    اندازه گیری توسط کیت آزمایشگاهی
    #5
    empty
    ٍEffect of fortified-bread with pomegranate peel powder on Malon dealdehyde level
    empty
    بررسی تاثیر نان غنی شده با پوست انار بر سطح مالون دی آلدئید
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by laboratory kit
    empty
    اندازه گیری توسط کیت آزمایشگاهی
    #6
    empty
    ٍEffect of fortified-bread with pomegranate peel powder on total antioxidant capacity level
    empty
    بررسی تاثیر نان غنی شده با پوست انار بر سطح ظرفیت تام آنتی اکسیدانی
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by laboratory kit
    empty
    اندازه گیری توسط کیت آزمایشگاهی
    #7
    empty
    C-reactive protein measurement with high sensitivity
    empty
    اندازه گیری پروتئین واکنشگر سی با حساسیت بالا
    empty
    Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
    empty
    در ابتدای مداخله و 12 هفته بعد از مصرف نان غنی شده با پوست انار
    empty
    Measurement by laboratory kit
    empty
    اندازه گیری توسط کیت آزمایشگاهی

  • Secondary outcomes

    #1
    Fasting blood glucose
    Depression, anxiety and stress scales
    قندخون ناشتا
    افسردگی، اضطراب و استرس
    Using a laboratory kit
    Questionnaire
    با استفاده از کیت آزمایشگاهی
    پرسشنامه
    #2
    Glycosylated hemoglobin
    weight
    هموگلوبین گلیکوزیله
    اندازه گیری وزن
    High performance chromatography
    scales
    با استفاده از کروماتوگرافی
    ترازو
    #3
    Fasting insulin
    waist
    انسولین ناشتا
    اندازه دور کمر
    Enzyme-linked immunosorbent assay (ELISA)
    Measuring meter
    کیت الایزا
    متر
    #4
    Triglyceride
    blood pressure
    تری گلیسرید
    فشارخون
    laboratory kit
    Blood pressure measuring device
    کیت آزمایشگاهی
    فشارسنج
    #5
    High density lipoprotein
    empty
    لیپوپروتیین با دانسیته بالا
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    laboratory kit
    empty
    کیت آزمایشگاهی
    empty
    #6
    Low density lipoprotein
    empty
    لیپوپروتیین با دانسیته پایین
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    Use the Friedwald formula
    empty
    استفاده از فرمول فریدوالد
    empty
    #7
    High-sensitivity C-reactive protein
    empty
    پروتیین واکنشگر C با حساسیت بالا
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    Enzyme-linked immunosorbent assay (ELISA)
    empty
    کیت الایزا
    empty
    #8
    Malondialdehyde
    empty
    مالون دی آلدهید
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    Enzyme-linked immunosorbent assay (ELISA)
    empty
    کیت الایزا
    empty
    #9
    Total antioxidant capacity
    empty
    ظرفیت آنتی اکسیدانی تام
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    Enzyme-linked immunosorbent assay (ELISA)
    empty
    کیت الایزا
    empty
    #10
    Depression, anxiety and stress scales
    empty
    پرسشنامه افسردگی، اضطراب و استرس
    empty
    Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
    empty
    در ابتدا و بعد از 12 هفته مصرف نان غنی شده با پوست انار
    empty
    Questionnaire
    empty
    پرسشنامه
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: Isfahan Endocrine Metabolic Research Center
    Name of recruitment center - Persian: مرکز تحقیقات غدد و متابولیسم اصفهان
    Full name of responsible person - English: Reza Amani
    Full name of responsible person - Persian: رضا امانی
    Street address - English: Khoram street, Isfahan Endocrine Metabolic Research center
    Street address - Persian: خیابان خرم ، مرکز تحقیقات غدد و متابولیسم
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 1187698191
    Phone: +98 31 3335 9933
    Fax: +98 31 3337 3733
    Email: emrc@mui.ac.ir
    Web page address: https://emrc.mui.ac.ir/
    Name of recruitment center - English: Esfahan Endocrine Metabolic Research Center and Health centers
    Name of recruitment center - Persian: مرکز تحقیقات غدد و متابولیسم اصفهان و مراکز بهداشت
    Full name of responsible person - English: Reza Amani
    Full name of responsible person - Persian: رضا امانی
    Street address - English: Khoram Street, Isfahan Endocrine Metabolic Research Center and Ibn Sina Street
    Street address - Persian: خیابان خرم ، مرکز تحقیقات غدد و متابولیسم- خ ابن سینا
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 1187698191
    Phone: +98 31 3335 9933
    Fax: +98 31 3337 3733
    Email: emrc@mui.ac.ir
    Web page address: https://emrc.mui.ac.ir/

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Reza Amani
    Full name of responsible person - Persian: رضا امانی
    Street address - English: Food security research center, Isfahan University of Medical Sciences, Hezar Jarib Street
    Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان، مرکز تحقیقات امنیت غذایی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3668 0048
    Fax:
    Email: r_amani@nutr.mui.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Reza Amani
    Full name of responsible person - Persian: رضا امانی
    Street address - English: Food Security Research Center, Isfahan University of Medical Sciences, Hezar Jarib Street
    Street address - Persian: خیابان هزار جریب، دانشگاه علوم پزشکی اصفهان، مرکز تحقیقات امنیت غذایی
    City - English: Isfahan
    City - Persian: اصفهان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8174673461
    Phone: +98 31 3668 0048
    Fax:
    Email: r_amani@nutr.mui.ac.ir
    Web page address:

Protocol summary

Study aim
The aim of the present study is to evaluate the effects of fortified-bread with pomegranate peel powder consumption on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, and mood in patients with type 2 diabetes
Design
This is a randomized, double-blind placebo-controlled, clinical trial. Ninety participants will randomly be allocated to either fortified-bread with pomegranate peel powder (n = 45) or placebo (n = 45).
Settings and conduct
Type 2 diabetic participants aged 40–60 years will be recruited from Isfahan Endocrine & Metabolism Research Center (IEMRC), Isfahan, Iran. Subjects will be randomly divided into control and intervention groups by simple randomization. Random assignment will be done using a table of random numbers. Participants will consume fortified-bread with 3.5 percent pomegranate peel powder and regular-bread in the intervention and the placebo group, respectively. Participants will replace 100 grams of fortified- or whole-bread with their daily bread.
Participants/Inclusion and exclusion criteria
The cases will be enrolled in the study if they meet the following inclusion criteria 1) Willing to participate in the study; 2) Diagnosis of diabetes in the last 5 years; 3) Body mass index (BMI) <30; 4) Glycosylated hemoglobin less than 8. The exclusion criteria are as following 1) Individuals with a history of cancer, cardiovascular disease, renal, hepatic, and thyroid disorders; 2) Using insulin or oral insulin-stimulating agents.
Intervention groups
Individuals will randomly be divided into two groups to receive either 100g wheat-bread with 3.5 percent PPP or placebo, daily for 12 weeks.
Main outcome variables
Fasting glucose; glycosylated hemoglobin; fasting insulin; serum lipid profile; mood status; inflammatory and antioxidant indices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191209045672N1
Registration date: 2020-09-21, 1399/06/31
Registration timing: prospective

Last update: 2022-11-09, 1401/08/18
Update count: 1
Registration date
2020-09-21, 1399/06/31
Registrant information
Name
Maryam Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3448 3768
Email address
mehr_mzare74@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of fortified-bread with pomegranate peel powder on anthropometric indices, lipid profile, glycemic indices, oxidative stress markers, mood and inflammation level in patients with type 2 diabetes
Public title
The effect of fortified- bread with pomegranate peel powder in the treatment of diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-60 Body mass index less than 30 Glycosylated hemoglobin less than 8 Willing to participate in the study, diagnosis of diabetes in the last 5 years Understanding the objectives of the study Written consent
Exclusion criteria:
No complications of diabetes Using insulin or oral agents inducing insulin secretion Smoking Pregnancy Lactation Taking antioxidant supplements within the last 3 months Having a history of cancer, cardiovascular disease, renal, hepatic and thyroid disorders before the intervention
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
A stratified randomized permuted block( with block size 4) will be generated by an independent bio-statistician. Random assignment will be done by the use of a table of random numbers. The participant's enrollment and assignment to the groups will be carried out by a trained nutritionist.
Blinding (investigator's opinion)
Double blinded
Blinding description
Fortified-bread with pomegranate peel powder(PPP) and its placebo (wheat bread) will be manufactured by the Simin bread workshop (Isfahan, Iran). Both fortified-bread and its placebo provided by the Simin bread workshop will be packed for each patient according to the randomization sequence. Fortified-bread and its placebo will be in similar packages and patients and researcher will not be aware of the content of the packages until the end of the trial. The intervention group will consume 100 gr of whole-wheat-bread with 3.5 percent PPP twice a week. The control group will consume 100 gr of whole-wheat-bread twice a week. The intervention will be continued for 3 months.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street,Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.087

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus type 2 due to underlying condition

Primary outcomes

1

Description
ٍEffect of fortified-bread with pomegranate peel powder on FBS level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

2

Description
ٍEffect of fortified-bread with pomegranate peel powder on HbA1c level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by chromatography

3

Description
ٍEffect of fortified-bread with pomegranate peel powder on insulin level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

4

Description
ٍEffect of fortified-bread with pomegranate peel powder on lipid profile level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

5

Description
ٍEffect of fortified-bread with pomegranate peel powder on Malon dealdehyde level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

6

Description
ٍEffect of fortified-bread with pomegranate peel powder on total antioxidant capacity level
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

7

Description
C-reactive protein measurement with high sensitivity
Timepoint
Before intervention and after 12 weeks consumption of fortified-bread with pomegranate peel powder
Method of measurement
Measurement by laboratory kit

Secondary outcomes

1

Description
Depression, anxiety and stress scales
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Questionnaire

2

Description
weight
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
scales

3

Description
waist
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Measuring meter

4

Description
blood pressure
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Blood pressure measuring device

Intervention groups

1

Description
Intervention group: In this group, subjects will use 100 grams of enriched-bread with pomegranate peel powder daily for breakfast and snacks for 12 weeks.
Category
Treatment - Other

2

Description
Control group: In this group, subjects will consume 100 grams of regular wheat bread for 12 weeks for breakfast and snacks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Esfahan Endocrine Metabolic Research Center and Health centers
Full name of responsible person
Reza Amani
Street address
Khoram Street, Isfahan Endocrine Metabolic Research Center and Ibn Sina Street
City
Isfahan
Province
Isfehan
Postal code
1187698191
Phone
+98 31 3335 9933
Fax
+98 31 3337 3733
Email
emrc@mui.ac.ir
Web page address
https://emrc.mui.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Amani
Street address
Food Security Research Center, Isfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
r_amani@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Amani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
r_amani@nutr.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Amani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
r_amani@nutr.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Amani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahal University of Medical Sciences,Isfahan,Iran
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
r_amani@nutr.mui.ac.ir

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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