The Effect of Curcumin Supplementation as Nano-micelles and Low Calorie- Low Glycemic Index Diet Education on Metabolic Syndrome Indices in patients referred to Taleghani Hospital diabetes clinic
Determining the Effect of Receiving the Curcumin Supplement as Nano-Micelles and Educating Low Calorie-Low Glycemic Index Diet on Metabolic Syndrome Indices.
The study will be conducted as a Double-Blind Randomized Controlled Trial with the standard placebo.
The required sample size for the study, considering the 20% probability of subject missing, will be 45 subjects for each groups and 90 subjects in total. All the subjects will be taught low calorie- low glycemic index diet, then subjects randomly will be divided to the two groups of receiving Curcumin or placebo. All of the procedures will be conducted double- blind to the researcher and patients alike and also in supervision of a third person. The intervention will be done for 12 weeks. Regarding the results of previous human studies conducted on Curcumin, consumption of these capsules will not have any side effect for patients.
Patients who have at least 3 criteria of all of 5 criteria of Metabolic Syndrome provided that not taking medicine for controlling Blood Glucose, Blood Lipid and Hypertension will be included to the study. In case of losing any of including criteria or having to taking any of aforementioned medications will be excluded from the study.
The main outcomes expected to be applied by the interventions, will be include: increase in High-Density Lipoprotein- Cholesterol (HDL-C) and reduce Triglycerides, Blood Pressure, Waist Circumference and Blood Glucose.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021326530N1
Registration date:2016-05-21, 1395/03/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-21, 1395/03/01
Registrant information
Name
Soheil Abbasi
Name of organization / entity
Kermanshah University of Medical Science, Public Halth Faculty
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 1991
Email address
s.abbasi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice – Chancellery of Research & Technology Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Curcumin Supplementation as Nano-micelles and Low Calorie- Low Glycemic Index Diet Education on Metabolic Syndrome Indices in patients referred to Taleghani Hospital diabetes clinic
Public title
Therapeutic Effects of Curcumin as Supplement on Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
The main including criteria:
Filling the consent form of the present project in the beginning of study; lack of any kinds of chronic diseases such as diabetes, renal diseases, tuberculosis, liver diseases and/or the history of cardiac surgery; possessing at least 3 items of all the 5 indexes of metabolic syndrome (based on the definition by NCEP ATP III) (in case of insulin resistance, patients must have fasting blood glucose less than 126 mg/dL, otherwise these patients diagnosed as diabetic patients and must have exclude from the study); lack of taking medicine to control blood glucose, blood lipid and hypertension; the age range between 25 to 65 year; lack of injecting insulin so as to blood glucose control.
The main exclusion criteria:
Lack of regular taking the given supplements; lack of following the given diet which evaluated by the analysis of 3 days recall questionnaire by using Nutritionist- 4 software; starting taking medicine or supplements that may be affect the results of test of investigated factors or oral contraceptives, estrogen, progesterone and corticosteroids; pregnancy; taking/receiving insulin or tablet to control the blood glucose; losing any of inclusion criteria during the time of conducting the study.
Age
From 24 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Science, Naft Square, Shahid Beheshti blvd.
City
Kermanshah
Postal code
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
kums.rec.1395.4
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15.9
ICD-10 code description
Secondary hypertension, unspecified
2
Description of health condition studied
Hyperglyceridaemia
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridaemia
3
Description of health condition studied
Prediabetic
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
4
Description of health condition studied
low HDL-C
ICD-10 code
E78.6
ICD-10 code description
High-density lipoprotein deficiency
Primary outcomes
1
Description
plasma Glucose
Timepoint
base line and aftar 3 months of begin
Method of measurement
in term of mg/ dL by biochemical kits
2
Description
blood pressure
Timepoint
base line, at the end of 6th week and aftar 3 months of begin
Method of measurement
in term of mm Hg by Mercury barometers
3
Description
plasma HDL-C
Timepoint
base line and aftar 3 months of begin
Method of measurement
in term of mg/ dL by biochemical kits
4
Description
plasma TG
Timepoint
base line and aftar 3 months of begin
Method of measurement
in term of mg/ dL by biochemical kits
5
Description
Waist Circumference
Timepoint
base line, at the end of 6th week and aftar 3 months of begin
Method of measurement
in term of centimeter by Tape measure
Secondary outcomes
1
Description
Total Cholesterol
Timepoint
baseline and after 3th month
Method of measurement
in term of mg/ dL, by using biochemical kits
2
Description
LDL-C
Timepoint
baseline and after 3th month
Method of measurement
in term of mg/ dL, by using biochemical kits
3
Description
Body Fat Mass
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg, by usig body analyser instrument
4
Description
Body Fat Free Mass
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg, by usig body analyser instrument
5
Description
Body Mass Index (BMI)
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg/ m2
6
Description
weight
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg by using standardized scale
Intervention groups
1
Description
for intervention group:
Curcumin Dietary Supplement, 40 mg soft gel, twice/ day by oral, for 3 months
Category
Treatment - Drugs
2
Description
for intervention and control groups:
training low calorie- low glycemic index diet. for all participants, this training will be taught in baseline and in the end of 6th week.
Category
Lifestyle
3
Description
for control group:
Standardized Placebo, quite similar to Curcumin soft gels, twice/ day, for 3 months by oral