The Effects of Barberry Supplementation on Oxidative Indices in Patients with Metabolic Syndrome
Design
The current study is a randomized, double-blind, placebo-controlled clinical trial with parallel groups. A total of 106 subjects were enrolled between November 2013 and March 2014.
Settings and conduct
Patients with metabolic syndrome who referred to Nutrition Clinic of the Ghaem Hospital were enrolled in the study. All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until data analysis. The placebo capsules were similar to the drugs regarding the weight and color.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18–65 years old, Patients with Metabolic Syndrome according to the International Diabetic Federation criteria; Exclusion criteria: Systemic diseases, Pregnant and lactating women, Drug usage (including consumption of the lipid-lowering, antihypertensive and antidiabetic drugs)
Intervention groups
1) Drug: a group receiving Barberry capsules (600 mg/day) for 6 weeks, 2) Placebo: the control group who taking a placebo capsule for a period of 6 weeks.
Main outcome variables
Anti-Heat Shock Protein titre; Pro-Oxidant–Antioxidant Balance; Superoxide Dismutase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110726007117N9
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
Registrant information
Name
Majid Ghayour Mobarhan
Name of organization / entity
Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1822 8573
Email address
ghayourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-11-26, 1392/09/05
Expected recruitment end date
2014-03-02, 1392/12/11
Actual recruitment start date
2013-11-26, 1392/09/05
Actual recruitment end date
2014-03-02, 1392/12/11
Trial completion date
2014-03-02, 1392/12/11
Scientific title
The Effects of Barberry Supplementation on Oxidative Indices in Patients with Metabolic Syndrome: A Randomized Double Blind Clinical Trial
Public title
The Effects of Barberry on Metabolic Syndrome Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18–65 years old
Patients with Metabolic Syndrome according to the International Diabetic Federation criteria
Exclusion criteria:
Systemic diseases such as lupus, kidney disease, acquired immunodeficiency syndrome and rheumatoid arthritis
Pregnant and lactating women
Drug usage including consumption of the lipid-lowering, antihypertensive and antidiabetic drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
53
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence was made using the computer randomization method. Sequentially numbered sealed envelopes were used to implement the random allocation sequence which opened by a person not involved in the project. The participants, care providers and statistician were blinded after assignment to intervention. So that, the capsules bottles were coded by a non-researcher person and remained confidential until data analysis. Moreover, the placebo capsules were similar to the Barberry ones concerning the shape, weight and color.
Blinding (investigator's opinion)
Double blinded
Blinding description
All subjects, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and color.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi Square, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2009-11-04, 1388/08/13
Ethics committee reference number
87480
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome
Primary outcomes
1
Description
Anti-Heat Shock Protein titre
Timepoint
Before the intervention and 6 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
2
Description
Pro-Oxidant–Antioxidant Balance
Timepoint
Before the intervention and 6 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
3
Description
Superoxide Dismutase
Timepoint
Before the intervention and 6 weeks after taking drug or placebo
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Serum Copper
Timepoint
Before the intervention and 6 weeks after taking drug or placebo
Method of measurement
Atomic Absorption
2
Description
Serum Zinc
Timepoint
Before the intervention and 6 weeks after taking drug or placebo
Method of measurement
Atomic Absorption
Intervention groups
1
Description
Intervention group: Subjects in the intervention group receive Barberry capsules (daily intake of 600 mg) for 6 weeks (n=53). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Khoosheh Sorkhe Shargh Agro Industrial company (Tehran, Iran).
Category
Treatment - Drugs
2
Description
Control group: Placebo capsules are prepared by a similar company and are similar to the Barberry capsules regarding the color, shape and size. The control group receive a placebo capsule for a period of 6 weeks. The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Khoosheh Sorkhe Shargh Agro Industrial company (Tehran, Iran).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Clinic of the Ghaem Hospital
Full name of responsible person
Majid Ghyaour-Mobarhan
Street address
Dr Shariati Square, Ahmadabad Street, Ghaem Hospital, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 21 3800 2288
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3800 2288
Email
ghayourm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhanر
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Azadi Square, Nutrition Depatment, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3800 2288
Email
ghayourm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Azadi Square, Faculty of Medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3800 2288
Email
ghayourm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After a reasonable request, deidentified data can be shared.
When the data will become available and for how long
After publication of paper(s) upon a reasonable request
To whom data/document is available
Study PI and executive team
Under which criteria data/document could be used
For reasonable research or clinical purpose
From where data/document is obtainable
Dr Mjid Ghayour Mobarhan
What processes are involved for a request to access data/document