The best of our aim is the comparison of curcumin’s effects in simple and modified formulations on cardiovascular risk factors in patients with metabolic syndrome. This study will be conducted on 120 metabolic syndrome patients aged 18–65 years who not having any history of systemic disease. A diagnosis of Metabolic syndrome was based on the IDF criteria : Abdominal obesity (waist circumference >94 cm for men and >80 cm for women), or an elevated BMI + 2 of the following: Triglycerides≥ 150 mg/dl, HDL-C< 40 mg/dl in men and <50 mg/dl in women, Blood pressure≥ 130/85 mmHg, Fasting glucose≥ 100 mg/dl. Subjects who are indicated for pharmacologic intervention according to the American Heart Association guidelines will be omitted from the study. Recruited patients will be randomly assigned to 3 groups receiving simple and modified curcumin (1 g/day) and placebo capsules for a period of 6 weeks. Each patient will have the same diet and visit once during drug consumption. Anthropometric indices, blood pressure and demographic information will be documented. CBC and lipids profile will be measured for everyone before and after intervention. The serum concentrations of interleukin-1α/-1β/-6 and TNF-α will be detected using Enzyme-Linked Immunosorbent Assay (ELISA). Our results can help determining the clinical benefits of supplementation with curcumin in patients with metabolic syndrome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014052014521N3
Registration date:2014-08-11, 1393/05/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-11, 1393/05/20
Registrant information
Name
Amirhossein Sahebkar
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9260
Email address
sahebkara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of curcumin’s effects in simple and modified formulations on cardiovascular risk factors in patients with metabolic syndrome
Public title
Comparison of curcumin’s effects in simple and modified formulations in patients with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Men and women aged 18-65 years ; Metabolic Syndrome patients (based on IDF guidelines) ; Consent to participate in research project ; Not taking any dietary supplement ; Not taking any drugs within the last 3-6 months (Not history of taking any lipid-lowering, diabetes and hypertension drugs or insulin within the last 3-6 months) .
Exclusion criteria : Lack of informed consent of patient to participate in research project ; Having systemic disease or history of systemic disease (such as lupus and kidney disease) ; Not having Metabolic Syndrome ; Pregnancy or lactation ; Consumption of any drug supplement or lipid-lowering drug within the last 3-6 months ; Metabolic syndrome subjects who need to take any drug (based on American Heart Association guidelines) .
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Mashhad University of Medical Sciences
Street address
Daneshgah Street
City
Mashhad
Postal code
۳۴۵ - ۹۱۳۷۵
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
921312
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Obesity
2
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
3
Description of health condition studied
hypertriglyceridaemia
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridaemia
4
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
5
Description of health condition studied
High-density lipoprotein deficiency
ICD-10 code
E78.6
ICD-10 code description
Lipoprotein deficiency
Primary outcomes
1
Description
Triglycerides
Timepoint
Baseline, week 6
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
Secondary outcomes
1
Description
Apo B
Timepoint
Baseline, week 6
Method of measurement
ELISA
2
Description
Apo A
Timepoint
Baseline, week 6
Method of measurement
ELISA
3
Description
Adiponectin
Timepoint
Baseline, week 6
Method of measurement
ELISA
4
Description
CETP
Timepoint
Baseline, week 6
Method of measurement
ELISA
5
Description
HS-CRP
Timepoint
Baseline, week 6
Method of measurement
immunoturbidimetric assay
6
Description
Lp (a)
Timepoint
Baseline, week 6
Method of measurement
ELISA
7
Description
CBC
Timepoint
Baseline, week 6
Method of measurement
Sysmex KX-21 Hematology Analyzer
8
Description
Total cholesterol
Timepoint
Baseline, week 6
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
9
Description
HDL-c
Timepoint
Baseline, week 6
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
10
Description
LDL-c
Timepoint
Baseline, week 6
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
11
Description
Prooxidant-antioxidant balance
Timepoint
Baseline, week 6
Method of measurement
Colorimetric assay
12
Description
PON
Timepoint
Baseline, week 6
Method of measurement
ELISA
13
Description
Anti- HSP27
Timepoint
Baseline, week 6
Method of measurement
ELISA
14
Description
interleukin-1β (IL-1β)
Timepoint
Baseline, week 6
Method of measurement
biochip array immunoassay
15
Description
interleukin-1α (IL-1α)
Timepoint
Baseline, week 6
Method of measurement
biochip array immunoassay
16
Description
interleukin-6 (IL-6)
Timepoint
Baseline, week 6
Method of measurement
biochip array immunoassay
17
Description
tumor necrosis factor (TNF-α)
Timepoint
Baseline, week 6
Method of measurement
biochip array immunoassay
18
Description
Intercellular Adhesion Molecule-1 (ICAM-1),
Timepoint
Baseline, week 6
Method of measurement
ELISA
19
Description
L-Selectin
Timepoint
Baseline, week 6
Method of measurement
ELISA
20
Description
Anxiety
Timepoint
Baseline, week 6
Method of measurement
Questionnaire
21
Description
Depression
Timepoint
Baseline, week 6
Method of measurement
Questionnaire
22
Description
Vascular Cell Adhesion Molecule-1 (VCAM-1)
Timepoint
Baseline, week 6
Method of measurement
ELISA
Intervention groups
1
Description
Simple Curcumin (unformulated)
Category
Treatment - Drugs
2
Description
Control group: placebo for 6 weeks
Category
Placebo
3
Description
Curcumin-phospholipid complex
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr. Majid Ghayour Mobarhan
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr Mohsen Tafaghodi
Street address
Pharmaceutical Chemistry Department , School of Pharmacy , Vakilabad blvd
City
Mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Sahebkar
Position
PhD. (Pharmaceutical Biotechnology)
Other areas of specialty/work
Street address
Biotechnology Department, School of Medicine, Vakilabad blvd
City
Mashhad
Postal code
Phone
+98 51 1800 2288
Fax
Email
sahebkara@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Sahebkar
Position
PhD. (Pharmaceutical Biotechnology)
Other areas of specialty/work
Street address
Biotechnology Department, School of Medicine, Vakilabad blvd
City
Mashhad
Postal code
Phone
+98 51 1800 2288
Fax
Email
sahebkara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Sahebkar
Position
PhD. (Pharmaceutical Biotechnology)
Other areas of specialty/work
Street address
Biotechnology Department, School of Medicine, Vakilabad blvd
City
Mashhad
Postal code
Phone
+98 51 1800 2288
Fax
Email
sahebkara@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)