The effect of consumption of barberry fruit powder on glycemic indices , lipid profile and Visfatin in type 2 diabetic patients
Design
Clinical trials with intervention and control group, with parallel groups, single blind, randomized
Settings and conduct
40 patients with type 2 diabetes who are referred to the diabetes clinic of Booali Hospital in Zahedan who are eligible to enter the study will be selected.The samples were randomly divided into two intervention groups (20 persons) and control group (20 people) by using case number.The intervention group received 1 g of barberry dried fruit powder (2 capsules of 500 mg) per serving (1 capsule with lunch and 1 capsule with dinner) daily, and the control group received placebo (a capsule containing lactose).All participants in the plan thought that they had received the intervention and that they were not known to be in the group receiving the barberry powder or the placebo group. The data analyst also stated that the data were from the consumer powder group Barberry or group receiving a placebo is unaware.
Participants/Inclusion and exclusion criteria
Entry requirements; All people with type 2 diabetes have been diagnosed,Use of fixed drugs during the intervention
Conditions not enter; Insulin treatment
Intervention groups
The intervention group received 1 g of barberry dried fruit powder (2 capsules of 500 mg) per serving (1 capsule with lunch and 1 capsule with dinner) daily, and the control group received placebo (a capsule containing lactose).
Main outcome variables
Visfatin; Fasting blood sugar; Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040758N1
Registration date:2018-10-06, 1397/07/14
Registration timing:prospective
Last update:2018-10-06, 1397/07/14
Update count:0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Shadi Shourestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 3865
Email address
shadi.shourestani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of consumption of barberry fruit powder on glycemic indices , lipid profile and Visfatin in type 2 diabetic patients
Public title
The effect of consumption of barberry fruit powder in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with type 2 diabetes are diagnosed
Exclusion criteria:
Pregnancy
Lactation
History of heart disease
History of heart failure in the last 3 months
heart attack
Acute and chronic hepatic disease, except fatty liver
Impaired kidney function
Hyperthyroidism and hypothyroidism
Use of NSAIDs
Insulin treatment
Taking antidepressants
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly with the help of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants in the plan thought that they had received the intervention and that they were not known to be in the group receiving the barberry powder or the placebo group. The data analyst also stated that the data were from the consumer powder group Barberry or group receiving a placebo is unaware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan Medical Science Campus, Hesabi Square,
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.201
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 suger
Timepoint
Beginning of the intervention and 60 days after the intervention
Method of measurement
Measure with laboratory kit on blood sample
2
Description
HbA1c
Timepoint
Beginning of the intervention and 60 days after the intervention
Method of measurement
Measure with laboratory kit on blood sample
3
Description
Lipid profile
Timepoint
Beginning of the intervention and 60 days after the intervention
Method of measurement
Measure with laboratory kit on blood sample
4
Description
Visfatin
Timepoint
Beginning of the intervention and 60 days after the intervention
Method of measurement
Measure with laboratory kit on blood sample
5
Description
Insulin
Timepoint
Beginning of the intervention and 60 days after the intervention
Method of measurement
Measure with laboratory kit on blood sample
Secondary outcomes
1
Description
Fasting blood suger
Timepoint
At the beginning of the intervention and 60 days after the intervention began
Method of measurement
Measure with laboratory kit on blood sample
2
Description
Hb A1c
Timepoint
At the beginning of the intervention and 60 days after the intervention began
Method of measurement
Measure with laboratory kit on blood sample
3
Description
Lipid profile
Timepoint
At the beginning of the intervention and 60 days after the intervention began
Method of measurement
Measure with laboratory kit on blood sample
4
Description
visfatin
Timepoint
At the beginning of the intervention and 60 days after the intervention began
Method of measurement
Measure with laboratory kit on blood sample
5
Description
Insulin
Timepoint
At the beginning of the intervention and 60 days after the intervention began
Method of measurement
Measure with laboratory kit on blood sample
Intervention groups
1
Description
Intervention group: The intervention group received 1 gram of powdered barberry dried fruit (2 capsules of 500mg) per serving for 2 months (1 capsule plus lunch and 1 capsule with dinner) for 2 months.
Category
Treatment - Other
2
Description
Control group: The control group received 1 g of placebo (2 capsules containing 500 mg of lactose) per day for 2 servings (1 capsule with lunch and 1 capsule with dinner) for 2 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Buali Hospital in Zahedan
Full name of responsible person
Shadi Shourestani
Street address
Buali Hospital, Daneshgah Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
boali@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor Mohammad Bakhshani
Street address
Medical Sciences Campus, Hasabay Square
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Shadi Shourestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 20, Khayyam St.,Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717763765
Phone
+98 56 3243 3865
Email
shadi.shourestani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzane montazerifar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
College of Medical Sciences, Hassabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743175
Phone
+98 54 3329 5740
Email
fmontazerifar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Shadi Shourestani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 20, Khayyam St., Pasdaran Blvd.
City
Birjand
Province
South Khorasan
Postal code
9717763765
Phone
+98 56 3243 3865
Email
shadi.shourestani@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