Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of curcumin supplementation on parameters of mental health, biomarkers of oxidative stress and gene expression related to insulin, lipid and inflammation in type 2 diabetic patients with coronary heart disease (CHD).
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Design
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Study design: Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive curcumin supplements (n=30) or placebo (n=30).
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Settings and conduct
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Among patients with CHD referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Patients aged 45-85 years diagnosed with type 2 diabetes and coronary heart disease. Exclusion Criteria: Patients with thyroid disorders, Severe renal insufficiency, hepatic failure, Those experiencing an acute myocardial infarction within the past 3 months, Patients undergoing cardiac surgery within the past 3 months.
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Intervention groups
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Intervention group: 1000 mg curcumin, once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally
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Main outcome variables
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Outcomes: Biomarkers of oxidative stress (primary outcomes) and parameters of mental health, and gene expression related to insulin, lipid and inflammation (secondary outcomes) will be quantified at study baseline and end-of-trial
General information
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Reason for update
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The updating process was done before publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N63
Registration date:
2019-08-10, 1398/05/19
Registration timing:
retrospective
Last update:
2020-10-01, 1399/07/10
Update count:
1
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Registration date
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2019-08-10, 1398/05/19
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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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Expected recruitment start date
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2019-06-17, 1398/03/27
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Expected recruitment end date
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2019-07-18, 1398/04/27
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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 effects of curcumin supplementation on parameters of mental health, biomarkers of oxidative stress and gene expression related to insulin, lipid and inflammation in type 2 diabetic patients with cardiovascular disease
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Public title
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The effects of curcumin supplementation in patients with coronary heart disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion Criteria: Patients aged 45-85 years
People diagnosed with type 2 diabetes and coronary heart disease.
Exclusion criteria:
Exclusion Criteria: Patients with thyroid disorders.
Severe renal insufficiency
hepatic failure
Those experiencing an acute myocardial infarction within the past 3 months
Patients undergoing cardiac surgery within the past 3 months
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Age
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From 45 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<65 and ≥65 y). Then, participants in each block will be randomly allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Cardiology clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules
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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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2019-06-16, 1398/03/26
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Ethics committee reference number
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IR.NIMAD.REC.1398.101
Health conditions studied
1
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Description of health condition studied
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Coronary Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic ischemic heart disease, unspecified
Primary outcomes
1
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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Description
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Beck Depression Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
2
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Description
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Beck Anxiety Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
3
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Description
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Pittsburgh Sleep Quality Index
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
4
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Description
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Expressed levels of PPAR-γ gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
5
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Description
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Expressed levels of LDL-R gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
6
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Description
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Expressed levels of IL-1 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
7
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Description
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Expressed levels of IL-8 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
8
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Description
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Expressed levels of TGF-beta gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
9
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
11
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Description
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Expressed levels of VEGF gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
Intervention groups
1
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Description
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Intervention group: 1000 mg curcumin, once a day, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally
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Category
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Placebo
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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National Institute for Medical Research Development of Iran (NIMAD)
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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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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available