Evaluation of the effectiveness of curcumin-piperine supplementation on inflammatory factors, cardiac biomarkers, atrial fibrillation and clinical outcomes after coronary artery bypass graft surgery (CABG): A randomized double-blind, placebo-controlled, dose–response pilot study
Determination of the effectiveness of curcumin-piperine supplementation on inflammatory factors, cardiac biomarkers, atrial fibrillation and clinical outcomes after CABG
Design
A randomized, double-blind, clinical trial performed on 60 people. Randomization is done using a valid website and a 4-block method.
Settings and conduct
This clinical trial will be performed in Chamran and Milad hospitals in Isfahan. Curcumin piperine and placebo will be administered in exactly the same packages to the patient. Patients and researchers will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Completion of a consent form, age 30 to 80 years, gastrointestinal tract with normal function, ejection fraction above 35%, arrest time 30 to 90 minutes. Exclusion criteria: Sensitivity to herbal products such as turmeric and pepper, Herbal supplementation consumption during 3 months before surgery, need for emergency surgery, need for pump balloon, addition of other surgery, pregnancy and lactation.
Intervention groups
Intervention group 1: three capsules, each capsule containing 500 mg of curcumin and 5 mg of piperine per day. Intervention group 2: Two capsules, each capsule containing 500 mg of curcumin and 5 mg of piperine plus one placebo. Intervention group 3: One capsule containing 500 mg of curcumin and 5 mg of piperine plus two placebo capsules. Control group: 3 placebo capsules, each capsule containing 500 mg of maltodextrin per day.
Main outcome variables
Inflammatory factors, cardiac biomarkers, and atrial fibrillation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049534N4
Registration date:2021-07-13, 1400/04/22
Registration timing:prospective
Last update:2021-07-13, 1400/04/22
Update count:2
Registration date
2021-07-13, 1400/04/22
Registrant information
Name
Mohammad bagherniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
bagherniya@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-19, 1400/05/28
Expected recruitment end date
2022-08-19, 1401/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of curcumin-piperine supplementation on inflammatory factors, cardiac biomarkers, atrial fibrillation and clinical outcomes after coronary artery bypass graft surgery (CABG): A randomized double-blind, placebo-controlled, dose–response pilot study
Public title
The effects of curcumin-piperne supplementation on CABG patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-80 years
Gastrointestinal normal function and with intestinal or oral nutrition criteria
Ejection fraction (EF) above 35%
Arrest Time (cardiac resuscitation) 30 to 90 minutes
Willingness to participate in the study and complete the consent form before surgery
Exclusion criteria:
Allergy to herbal products such as turmeric and pepper
Taking herbal supplements (as a supplement) during 3 months before the operation
Need for emergency surgery
Requires balloon pump
Adding another operation in addition to CABG, like simultaneous valve operation
Patients who do not have an indication for intestinal or oral nutrition on the first day of the intervention and are expected to be unable to receive intestinal or oral nutrition in the future
Patients with a history of underlying disease such as congenital and immune disorders and pancreatitis
Pregnancy and lactation
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding the researchers, curcumin piperine and placebo capsules are purchased from Sami labs Ltd., India similar in shape, color, and size. These capsules are coded by someone other than the researchers (A and B) and the researcher distributes them without knowing the type of capsules. Patients and researchers will not be aware of the type of capsule until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.135
Health conditions studied
1
Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
C reactive Protein (CRP)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
2
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
3
Description
Blood urea nitrogen (BUN)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
4
Description
Creatinine (Cr)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
5
Description
Lactate Dehydrogenase (LDH)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
6
Description
Cell Blood Count (CBC)
Timepoint
At baseline and end of the study
Method of measurement
ELISA test
7
Description
CK-MB
Timepoint
At baseline and end of the study
Method of measurement
Commercial diagnostic kit
8
Description
Troponin
Timepoint
At baseline and end of the study
Method of measurement
Commercial diagnostic kit
Secondary outcomes
1
Description
28-days mortality rate
Timepoint
End of the study
Method of measurement
Mathematically dividing the number of dead people by the total number of people using hospital records or telephone follow-up
2
Description
Duration of hospitalization in ICU
Timepoint
End of the study
Method of measurement
Hospital records
3
Description
Atrial fibrillation
Timepoint
End of the study
Method of measurement
Electrocardiogram (ECG or EKG)
Intervention groups
1
Description
Intervention group 1:Patients who receive three capsules containing 500 mg of curcumin and 5 mg of piperine per day for 7 days
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients receiving two capsules containing 500 mg of curcumin and 5 mg of piperine for 7 days plus a placebo containing 500 mg of maltodextrin per day
Category
Treatment - Drugs
3
Description
Intervention group 3: Patients receiving one capsule containing 500 mg curcumin and 5 mg piperine for 7 days plus two placebo tablets containing 500 mg maltodextrin per day
Category
Treatment - Drugs
4
Description
Control group: Patients receiving 3 placebo capsules for 7 days, each capsule containing 500 mg of maltodextrin per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان قلب شهید چمران
Full name of responsible person
Sahar Dadkhah Tehrani
Street address
Salman Farsi St.
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
chamran@mui.ac.ir
2
Recruitment center
Name of recruitment center
Milad hospital
Full name of responsible person
Sahar Dadkhah Tehrani
Street address
Shahid bakhshi st, Janbazan st
City
Isfahan
Province
Isfehan
Postal code
8179663467
Phone
+98 31 3777 4009
Email
miladhospital.esf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
بهروز عطایی
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3972 3138
Email
bagherniya@nutr.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Bagherniya
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
bagherniya@nutr.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study information will be published after the individuals are unidentified and after the project is completed.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further analysis
From where data/document is obtainable
Dr. Mohammad Baghernia bagherniya@nutr.mui.ac.ir
What processes are involved for a request to access data/document
After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.