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
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:2020-09-21, 1399/06/31
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 Ave,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 cholesterol level
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
Fasting blood glucose
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Using a laboratory kit
2
Description
Glycosylated hemoglobin
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
High performance chromatography
3
Description
Fasting insulin
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
4
Description
Triglyceride
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
laboratory kit
5
Description
High density lipoprotein
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
laboratory kit
6
Description
Low density lipoprotein
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Use the Friedwald formula
7
Description
High-sensitivity C-reactive protein
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
8
Description
Malondialdehyde
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
9
Description
Total antioxidant capacity
Timepoint
Before intervention and after 12 weeks consumption of fortified bread with pomegranate peel powder
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)
10
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
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
Isfahan Endocrine Metabolic Research Center
Full name of responsible person
Reza Amani
Street address
Khoram street, Isfahan Endocrine Metabolic Research center
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