The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
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Secondary outcomes
#1
at the beginning,and end of the week of 4,8,12
at the beginning,and end of the study
at the beginning,and end of the week of 4,8,12study
ابتدای ، پایان هفته 4، پایان هفته 8 و انتهای مطالعه
ابتدا و انتهای مطالعه
ابتدای ، پایان هفته 4، پایان هفته 8ابتدا و انتهای مطالعه
#2
at the beginning,and end of the week of 4,8,12
at the beginning,and end of the study
at the beginning,and end of the week of 4,8,12study
ابتدای ، پایان هفته 4، پایان هفته 8 و انتهای مطالعه
ابتدا و انتهای مطالعه
ابتدای ، پایان هفته 4، پایان هفته 8ابتدا و انتهای مطالعه
#3
at the beginning,and end of the week of 4,8,12
at the beginning,and end of the study
at the beginning,and end of the week of 4,8,12study
ابتدای ، پایان هفته 4، پایان هفته 8 و انتهای مطالعه
ابتدا و انتهای مطالعه
ابتدای ، پایان هفته 4، پایان هفته 8ابتدا و انتهای مطالعه
#4
empty
blood pressure
blood pressure
empty
فشار خون
فشار خون
empty
at the beginning,and end of the study
at the beginning,and end of the study
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
Korotkoff sound technique with a calibrated mercury sphygmomanometer
Korotkoff sound technique with a calibrated mercury sphygmomanometer
empty
با دستگاه فشار سنج
با دستگاه فشار سنج
#5
empty
Body composition (fat mass (FM), free fat mass (FFM), muscle mass (MM))
Body composition (fat mass (FM), free fat mass (FFM), muscle mass (MM))
empty
ترکیب بدن (توده بدون چربی، توده چربی، توده ماهیچه)
ترکیب بدن (توده بدون چربی، توده چربی، توده ماهیچه)
empty
at the beginning,and end of the study
at the beginning,and end of the study
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
bioelectrical impedance analysis (BIA) method by a Body Composition Analyzer (InBody 270, Seoul, South Korea)
bioelectrical impedance analysis (BIA) method by a Body Composition Analyzer (InBody 270, Seoul, South Korea)
Short form of the International Physical Activity Questionnaire (IPAQ-SF)
Short form of the International Physical Activity Questionnaire (IPAQ-SF)
empty
پرسشنامه فعالیت فیزیکی (IPAQ-SF)
پرسشنامه فعالیت فیزیکی (IPAQ-SF)
#8
empty
Health-related quality of life
Health-related quality of life
empty
کیفیت زندگی
کیفیت زندگی
empty
at the beginning,and end of the study
at the beginning,and end of the study
empty
ابتدا و انتهای مطالعه
ابتدا و انتهای مطالعه
empty
SF-36 questionnaire
SF-36 questionnaire
empty
پرسشنامه sf-36
پرسشنامه sf-36
Protocol summary
Study aim
The determining of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
84 patients referring to Yazd Diabetes Specialty Clinic who meet the inclusion criteria will be randomly divided into 4 groups by random sampling. General Characterization and the assessment of anthropometric, diet, Weight loss, physical activity, and biochemistry will conduct for each patient. After 3 months of supplementation, the above assessment will be re-evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Both genders age: 18-50 years, prediabetic patients, BMI=25-35 No use of blood glucose-lowering drugs, written informed consent from patients
Exclusion criteria:
Having a history of gestational diabetes,- Pregnancy or lactation in women, Use of multivitamin-mineral supplements from three months before and during the intervention, a history of weight loss surgery in the last year, weight loss plan in the last 3 months, Sensitivity to supplementation or non-compliance during the intervention, Simultaneously participate in another project, Unwillingness to continue cooperation
The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
Public title
The investigating of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, inflammatory and antioxidant biomarkers in pre-diabetic patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
both genders
age: 18-50 years (for women 18 years before menopause
individuals with IFG =100-125 (mg/dL), IGT =140-199(mg/dL), or/and HbA1c=% 6.4 -5.7 ,
individuals with BMI=25-35
No use of blood glucose-lowering drugs such as Metformin or Glucophage
individuals with written informed consent from patients
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent selection bias from occurring after randomization, the concealment allocation method will be used to assign binary codes to each individual.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the study, a person other than the researchers will code the packages including two cans according to the number of participants in the study to keep the researcher informed about the type of pills received by each group. Each individual is delivered a pack including two cans. On each can, how to use the pills will be explained. Package 1 will contain (can1: placebo for curcumin supplement (bb), and can 2: zinc supplement (AA)); package 2 will contain (can1: placebo for zinc supplement (aa), and can 2: curcumin supplement (BB)); Package 3 will contain (can 1: zinc supplementation (AA) and can 2: curcumin supplementation (BB)), package 4 will contain (can 1: placebo for curcumin supplement (aa), and can 2: placebo for zinc supplement (bb)).
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan high way, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-10-05, 1398/07/13
Ethics committee reference number
IR.AJUMS.REC.1398.504
Health conditions studied
1
Description of health condition studied
Pre-diabetic
ICD-10 code
R-73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
at the beginning and end of study
Method of measurement
serum sample
2
Description
serum insulin
Timepoint
at the beginning and end of study
Method of measurement
serum sample
3
Description
hemoglobin A1c
Timepoint
at the beginning and end of study
Method of measurement
serum sample
4
Description
serum triglyceride
Timepoint
at the beginning and end of study
Method of measurement
serum sample
5
Description
insulin resistance
Timepoint
at the beginning and end of study
Method of measurement
insulin resistance formula (HOMA-IR)
6
Description
insulin sensitivity
Timepoint
at the beginning and end of study
Method of measurement
insulin sensitivity formula
7
Description
beta-cell function
Timepoint
at the beginning and end of study
Method of measurement
formula
8
Description
total cholesterol
Timepoint
at the beginning and end of study
Method of measurement
serum sample
9
Description
serum Low Density lipoprotein -Cholesterol (LDL-C)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
10
Description
serum Low Density lipoprotein -Cholesterol (HDL-C )
Timepoint
at the beginning and end of study
Method of measurement
serum sample
11
Description
Malondialdehyde (MDA)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
12
Description
Total Antioxidant Capacity (TAC)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
13
Description
serum zinc
Timepoint
at the beginning and end of study
Method of measurement
serum sample
14
Description
interleukin 1-B (IL-1B )
Timepoint
at the beginning and end of study
Method of measurement
serum sample
15
Description
C- Reaction Protein (CRP)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
16
Description
High sensitivity C- Reaction Protein(hs-CRP)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
Secondary outcomes
1
Description
Aspartate Transaminase (AST)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
2
Description
Alanine Transaminase (ALT)
Timepoint
at the beginning and end of study
Method of measurement
serum sample
3
Description
weight
Timepoint
at the beginning,and end of the study
Method of measurement
seca scales
4
Description
height
Timepoint
at the beginning
Method of measurement
stadiometer
5
Description
waist circumference
Timepoint
at the beginning,and end of the study
Method of measurement
tape
6
Description
hip circumference
Timepoint
at the beginning,and end of the study
Method of measurement
tape
7
Description
blood pressure
Timepoint
at the beginning,and end of the study
Method of measurement
Korotkoff sound technique with a calibrated mercury sphygmomanometer
8
Description
Body composition (fat mass (FM), free fat mass (FFM), muscle mass (MM))
Timepoint
at the beginning,and end of the study
Method of measurement
bioelectrical impedance analysis (BIA) method by a Body Composition Analyzer (InBody 270, Seoul, South Korea)
Ahvaz Jundishapur University of Medical Sciences, Golestan highway,Ahvaz, Iran,
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
azhdari_mar@yahoo.com
Web page address
http://www.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran,
Proportion provided by this source
60
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
2
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masood.Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences and Health Services, Shahid bahonar Square, shihid sadoughi BLv, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3724 0173
Email
azhdari_mar@yahoo.com
Web page address
http://www.ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
40
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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Azhdari
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of clinical biochemistry, Faculty (school) of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Saffaeieh, Alem Square, Shohadaye Gomnan BLv, Yazd, Iran.( Postal Code: 8916178477)
City
Yazd
Province
Yazd
Postal code
8916116364
Phone
+98 35 3821 9196
Fax
Email
azhdari_mar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Azhdari
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of clinical biochemistry, Faculty (school) of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Saffaeieh, Alem Square, Shohadaye Gomnan BLv, Yazd, Iran.( Postal Code: 8916178477)
City
Yazd
Province
Yazd
Postal code
8916116364
Phone
+98 35 3821 9196
Fax
Email
azhdari_mar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Azhdari
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of clinical biochemistry, Faculty (school) of Medicine, Shahid Sadoughi University of Medical Sciences and Health Services, Saffaeieh, Alem Square, Shohadaye Gomnan BLv, Yazd, Iran.( Postal Code: 8916178477)
City
Yazd
Province
Yazd
Postal code
8916116364
Phone
+98 35 3821 9196
Fax
Email
azhdari_mar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all data is related to primary and secondary outcome, will be reported.
When the data will become available and for how long
After the manuscript publication.
To whom data/document is available
After publication, it will be possible for everyone.
Under which criteria data/document could be used
Using the documentation with citation
1- To conduct similar and extensive research
2- To use the method of a project
3. To write systematic Review and meta-analysis articles
From where data/document is obtainable
1- Refer to the Library of Ahvaz Jundishapur University of Medical Sciences
1-Refer to the Library of Yazd University of Medical Sciences
3- Email to Maryam Azdari: azhdari_mar@yahoo.com)
What processes are involved for a request to access data/document
Everyone can use the data Referring to the library of the above-mentioned universities or by the emailing, for received data by email, it will be necessary to explain the reason for the using the data completely and clearly. He/she will be received within a maximum of one week.