Protocol summary
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Study aim
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The aim of this study is to evaluate the effect of saffron pill on lipid profiles and blood glucose and oxidative stress in obese diabetic patients
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Design
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In this research, 80 pre-diabet patients referring to Emam Ali clinic were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
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Settings and conduct
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A randomized clinical trial was conducted on pre-diabetes patients referring to Imam Ali Clinic, Also, the participants were blinded by this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:all patients with BMI greater than 25 who referring to the Imam Ali nutrition clinic, which are defined as pre-diabetes
Exclusion criteria: :Lack of interest in cooperation– Pregnancy- change in diet or physical activity- change in dosage and type of drug- Not having other diseases in during the study- Do not use more than 30% pills
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Intervention groups
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saffron receiving group
placebo receiving group
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Main outcome variables
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Fasting blood glucose
Oral glucose tolerance test
hemoglobin A1C
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120913010826N19
Registration date:
2018-01-04, 1396/10/14
Registration timing:
registered_while_recruiting
Last update:
2018-01-04, 1396/10/14
Update count:
1
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Registration date
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2018-01-04, 1396/10/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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shahid sadoughi university of medical sciences
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Expected recruitment start date
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2017-11-01, 1396/08/10
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Expected recruitment end date
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2018-01-30, 1396/11/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of saffron tablet on lipid profiles and blood glucose and oxidative stress in obese prediabetic patients
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Public title
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The effect of saffron tablet in obese prediabetic patients
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
all patients which are defined as pre-diabetes who referring to the Imam Ali nutrition clinic
all patients with BMI greater than 25 who referring to the Imam Ali nutrition clinic
Exclusion criteria:
Pregnancy
change in diet or physical activity
change in dosage
change in type of drug
Lack of interest in cooperation
having other diseases in during the study
Do not use more than 30% pills
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another independent researcher will measure the patients outcome and she will not know the allocation.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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dietary supplements and placebo produced and coded in similar shape, color, and size by the company. Allocation concealment will be done using sealed envelopes. So, principal researcher, clinician, and participants are not aware about group assignment.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-03-05, 1394/12/15
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Ethics committee reference number
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IR.SSU.SPH.REC.1394.113
Health conditions studied
1
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Description of health condition studied
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Obese Pre-dabetic
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ICD-10 code
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R73.02
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ICD-10 code description
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Impaired glucose tolerance (oral)
Primary outcomes
1
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Description
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LDL (lipid profile index)
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Timepoint
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Before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
2
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Description
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TG (lipid profile index)
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Timepoint
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Before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
3
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Description
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cholesterol(lipid profile index)
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Timepoint
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Before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
Secondary outcomes
1
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Description
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triglyceride, , LDL-Chol, BUN, Creatinine, DPPH
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
2
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Description
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cholesterol
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
3
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Description
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LDL cholesterol concentration
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
4
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Description
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BUN
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
5
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Description
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creatinine
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
6
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Description
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DPPH
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Timepoint
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before and after intervention
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Method of measurement
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Standards of medical diagnostic laboratories
Intervention groups
1
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Description
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The control group will receive placebo (the same as saffron pill in doses of 15mg)once a day for 8 weeks
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Category
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Placebo
2
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Description
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The intervention group will receive saffron pill in dosage 15 mg ,once a day (for 8 weeks)
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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data report will be shared after publishing the paper.
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When the data will become available and for how long
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Six months after publish
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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Using for Meta-analysis
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From where data/document is obtainable
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Center nutrition, public health, univercity of medical sciencies yazd
Tel: 009835 31492239
Email: azadehnajarzadeh@gmail.com
Azadenadjarzadeh
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What processes are involved for a request to access data/document
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It will be sent two weeks after the receipt of the email with the consent of the co-workers
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Comments
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