Dyslipidemia is a leading risk factor for cardiovascular disease and is also a common feature of obesity. Curcumin is a bioactive phytochemical with well-known antioxidant, anti-inflammatory and cardioprotective properties. The present study investigated the clinical efficacy of of curcumin in obese individuals. Participants (n = 30) were treated with curcuminoids (1 g/day), or placebo for a period of 4 weeks each (intermitted by a two-week wash-out phase) in a randomized, double-blind, placebo-controlled, cross-over trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013082914521N1
Registration date:2013-09-14, 1392/06/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-14, 1392/06/23
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
Mashhad University of Medical Sciences
Expected recruitment start date
2010-08-21, 1389/05/30
Expected recruitment end date
2012-08-20, 1391/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effects of supplementation with curcuminoids on on cardiovascular risk factors in obese dyslipidemic subjects
Public title
Investigation of the effects of curcuminoids on the risk of heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obese subjects (with body mass index (BMI) ≥ 30) who had either < 2 risk factors (except diabetes mellitus) for coronary heart disease (CHD) plus 160 mg/dL < LDL-C < 190 mg/dL, or ≥ 2 CHD risk factors (except diabetes mellitus) and 130 mg/dL < LDL-C < 160 mg/dL. Exclusion criteria were history of systemic diseases (such as systemic lupus erythematosus, kidney disease, diabetes mellitus and established cardiovascular disease), consumption of drug supplements within the preceding 6 months and history of taking any lipid-lowering drug.
Exclusion criteria: systemic disease or history of systemic disease (such as lupus, kidney disease, diabetes mellitus); history of cardiovascular disease; BMI < 30; consumption of drug supplements within the 6 months and history of taking any lipid lowering drug.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Daneshgah st., PO Box: 91375-345
City
Mashhad
Postal code
9177899191
Approval date
2010-05-12, 1389/02/22
Ethics committee reference number
88313
Health conditions studied
1
Description of health condition studied
Dyslipidemia
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total cholesterol
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
2
Description
Triglycerides
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
3
Description
HDL cholesterol
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
4
Description
LDL cholesterol
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Routine enzymatic methods using standard biochemistry kits on an autonalyzer
Secondary outcomes
1
Description
vitamin C, vitamin E, lipoprotein(a) and cathepsin D
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Questionnaire, enzymatic and immunoassay kits
2
Description
Anxiety
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Questionnaire
3
Description
Serum small dense LDL
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzyme immunoassay
4
Description
Heat shock protein 27 antibodies
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzyme immunoassay
5
Description
Pro-oxidan-antioxidant blance
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Colorimetric assay
6
Description
Cytokines
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzyme immunoassay
7
Description
Superoxide dismutase
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzymatic assay
8
Description
Zinc
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzymatic assay
9
Description
Copper
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzymatic assay
10
Description
Vitamins
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzymatic assay
11
Description
Lipoprotein(a)
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzyme immunoassay
12
Description
Cathepsin D
Timepoint
Baseline, week 4, week 6 and week 10
Method of measurement
Enzyme immunoassay
Intervention groups
1
Description
Curcuminoids are bioactive ingredients of turmeric. They belong to the polyphenol group of phytochemicals. The chemical name of curcumin is (1E,6E)-1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione. In the present trial curcumin would be administered b.i.d in two divided doses of 500 mg.
Category
Treatment - Drugs
2
Description
Control group: placebo for 4 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences Research Council
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah st.
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 Research Council
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
Cardiovascular Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Position
Associate Professor, MD, PhD
Other areas of specialty/work
Street address
School of Medicine, Vakilabad blvd.
City
Mashhad
Postal code
Phone
+98 51 1882 9260
Fax
Email
ghayourm@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cardiovascular Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Position
Associate Professor/MD-PhD
Other areas of specialty/work
Street address
School of Medicine, Vakilabad blvd.
City
Mashhd
Postal code
Phone
+98 51 1882 9260
Fax
Email
ghayourm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiovascular Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Position
MD-PhD
Other areas of specialty/work
Street address
School of Medicine
City
Mashhad
Postal code
Phone
+98 51 1882 9260
Fax
Email
ghayourm@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)