The Effects of Saffron 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 September 2010 and March 2011.
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: 18–75 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
Intervention groups
1) Drug: a group receiving Barberry capsules (100 mg/day) for 12 weeks, 2) Placebo: the control group who taking a placebo capsule for a period of 12 weeks.
The Effects of Saffron Supplementation on Oxidative Indices in Patients with Metabolic Syndrome
Public title
Effect of Saffron in Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18–75 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 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: The random allocation sequence was made using the computer randomization method. Sequentially numbered sealed envelopes were used to concealment the random allocation sequence which opened by a person not involved in the project.
Blinding (investigator's opinion)
Double blinded
Blinding description
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 Saffron ones concerning the shape, 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
Faculty of Medicine, Azadi Square, Mashhad
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 12 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
2
Description
Pro-Oxidant–Antioxidant Balance
Timepoint
Before the intervention and 12 weeks after taking drug or placebo
Method of measurement
Enzyme Linked Immunosorbent Assay
3
Description
Superoxide Dismutase
Timepoint
Before the intervention and 12 weeks after taking drug or placebo
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Serum Copper
Timepoint
Before the intervention and 12 weeks after taking drug or placebo
Method of measurement
Atomic Absorption
2
Description
Serum Zinc
Timepoint
Before the intervention and 12 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 100 mg) for 12 weeks (n=35). The participants take 2 capsule 50 mg every day, which was contained in an unlabeled bottle. Capsules are from Novin Saffron company (Mashhad, Iran).
Category
Treatment - Drugs
2
Description
Control group: Control group: Placebo capsules are prepared by a similar company and are similar to the Saffron capsules regarding the color, shape and size. The control group receive a placebo capsule for a period of 12 weeks. The participants take 2 capsule 50 mg every day, which was contained in an unlabeled bottle. Capsules are from Novin Saffron company (Mashhad, Iran).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0001
Fax
+98 51 3845 3239
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, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3800 2288
Fax
+98 51 3800 2287
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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
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- Mobarhan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Azadi Square
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 Ghayiur-Mobarhan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Medicine, Aazadi Square
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
Raw data will be shared upon a reasonable request from the corresponding author.
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
Undecided - It is not yet known if there will be 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
Following a reasonable request, deidentified data will 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 Majid Ghayour-Mobarhan
What processes are involved for a request to access data/document