The Effects of Intake of the Fortified Bread by Whey Protein Concentrate on Glycemic Control, Lipid Profile, Blood Presure, Anthropometric Parameters, Resting Energy Expenditure, Oxidative Stress Markers and Appetite in Women With Type 2 Diabetes Mellitus
The Effects of Intake of the Fortified Bread by Whey Protein Concentrate on Glycemic Control, Lipid Profile, Blood Presure, Anthropometric Parameters, Resting Energy Expenditure, Oxidative Stress Markers and Appetite in Women With Type 2 Diabetes Mellitus
Design
Parallel randomized controlled clinical trial with a sample size of 44 people
Settings and conduct
The practical stages of the study are carried out in Tabriz . Women with type 2 diabetes will selected with an endocrinologist diagnosis.
Participants/Inclusion and exclusion criteria
Women with type 2 diabetes aged between 25-55 years. Patients who control their diabetes by glucose lowering tablets and do not use insulin.
Inclusion criteria:
1) Willingness to cooperation
2) Women with type 2 diabetes mellitus
3) Women aged 25-55 years
4) Glucose lowering tablets usage
5) BMI= 25-35 kg/m2
6) GFR > 60 ml/min
Exclusion criteria:
1) Unwillingness to cooperation
2) Patients with inflammatory, immunologic, psychologic, pulmonary, and neoplastic diseases
3) Patients with renal, hepatic, and thyroid disorders
4) Supplement intake
5) Use of corticosteroids, non-steroidal anti-inflammatory, and hormonal drugs
6) Change in type or dosage of used drugs during the study
7) Change in diet and physical activity during the study
8) Tobacco use
9) Use of insulin
10) Special physiologic conditions such as pregnancy, lactation, and menopause
11) Patients with malabsorption diseases such as sprue and Crohn's disease
12) Allergy or intolerance to milk components
Intervention groups
Qualified patients will be randomly divided into 2 groups of: Intervention group: Fortified whole bread by whey protein concentrate; Control group: Whole bread
Main outcome variables
Blood glucose, Oxidative stress markers: TAC, MDA
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110123005670N26
Registration date:2019-01-07, 1397/10/17
Registration timing:prospective
Last update:2019-01-07, 1397/10/17
Update count:0
Registration date
2019-01-07, 1397/10/17
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Intake of the Fortified Bread by Whey Protein Concentrate on Glycemic Control, Lipid Profile, Blood Presure, Anthropometric Parameters, Resting Energy Expenditure, Oxidative Stress Markers and Appetite in Women With Type 2 Diabetes Mellitus
Public title
The Effects of Intake of the Fortified Bread by Whey Protein Concentrate in Women With Type 2 Diabetes Mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperation
Women with type 2 diabetes mellitus
Women aged 25-55 years
glucose lowering tablets usage
BMI= 25-35 kg/m2
GFR > 60 ml/min
Exclusion criteria:
Unwillingness to cooperation
Patients with inflammatory, immunologic, psychologic, pulmonary, and neoplastic diseases
Patients with renal, hepatic, and thyroid disorders
Supplement intake
Use of corticosteroids, non-steroidal anti-inflammatory, and hormonal drugs
Change in type or dosage of used drugs during the study
Change in diet and physical activity during the study
Tobacco use
Use of insulin
Special physiologic conditions such as pregnancy, lactation, and menopause
Patients with malabsorption diseases such as sprue and Crohn's disease
Allergy or intolerance to milk components
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Women who have the inclusion criteria, will be divided to intervention and placebo groups via simple randomization method.
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TBZMED.REC.1397.687
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Enzymatic by commercial kits
2
Description
Insulin
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
ELISA
3
Description
Hemoglobin A1C
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
ELISA with commercial kits
4
Description
HOMA-IR
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Calculation
5
Description
Triglyceride
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Enzymatic
6
Description
HDL-Cholesterol
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Enzymatic
7
Description
MDA
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
spectrophotometry
8
Description
TAC
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
spectrophotometry
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Digital Barometer
2
Description
Weight
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Scale
3
Description
Body Mass Index (BMI)
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Computing
4
Description
Body fat percent
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Bio impedance set
5
Description
waist circumference
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
measurement by meter
6
Description
Hip circumference
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
measurement by meter
7
Description
WHR
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Computing
8
Description
Appetite
Timepoint
Before the intervention and 90 days after the start of the intervention
Method of measurement
Appetite Assessment Questionnaire
Intervention groups
1
Description
Intervention group: About 120 g fortified whole bread by whey protein concentrate per day for 90 days
Category
Treatment - Other
2
Description
Control group: About 120 g whole bread per day for 90 days
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Nouri
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Fax
+98 41 3334 0634
Email
mrm.nouri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat-Esfanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Email
Tarighata@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat-Esfanjani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Email
Tarighata@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam Nouri
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 2117
Email
mrm.nouri@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
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