Protocol summary
-
Study aim
-
Determining the effect of curcumin bergamot supplement on blood triglyceride
-
Design
-
Clinical trial, randomized, double-blind, randomized control group of 40 patients. Randomization is done using a valid website and 4-block method.
-
Settings and conduct
-
This clinical trial will be performed in the special clinic of Sedigheh Tahereh Hospital. Curcumin bergamot and placebo are given to the patient in exactly the same packages. Patients and researchers will not be aware of the type of intervention.
-
Participants/Inclusion and exclusion criteria
-
Age 18 to 65 years
Fasting blood triglycerides above 150 mg / dL
Taking statins
-
Intervention groups
-
Intervention group Capsules containing curcumin and bergamot each contain 100 mg of curcumin and 200 mg of bergamot once a day. Control group 1 capsule each containing 300 mg of lactose
-
Main outcome variables
-
Fasting blood glucose, fasting blood TG, fasting blood Cholesterol, fasting blood LDL, fasting blood HDL
General information
-
Reason for update
-
Due to the outbreak of COVID-19, the implementation of the project is delayed. In addition, some problems in providing supplements and problems regarding budget allocation caused this project delay.
Personal problems of some colleagues in performing clinical procedures forced us to recruit new colleagues to perform the project.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2015071314521N4
Registration date:
2017-03-02, 1395/12/12
Registration timing:
prospective
Last update:
2022-04-20, 1401/01/31
Update count:
1
-
Registration date
-
2017-03-02, 1395/12/12
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Mashhad University of Medical Sciences
-
Expected recruitment start date
-
2022-05-04, 1401/02/14
-
Expected recruitment end date
-
2022-07-21, 1401/04/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effects of curcumin bergamot supplementation on fasting triglyceride levels in patients with hypertriglyceridemia taking statin: A randomized double-blind clinical trial
-
Public title
-
Curcumin and hypertriglyceridemia
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Age 18-65 years
Fasting serum TG>150 mg/dl
Using Statin drugs
Exclusion criteria:
Unwillingness to participate in the study
Sensitivity to herbal supplements
-
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:
40
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization is done individually. Entry of each patient into the intervention or control group is done randomly with the help of 4 blocking. This is done using a reputable random number generation website. (Random number generation website:
https://www.sealedenvelope.com/simple-randomiser/v1/lists)
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
The study will be double blinded so that the researcher and the subjects will not know which group they belong to. For blinding, curcumin bergamot and placebo capsules are prepared in the same shape, color, and size. These capsules are coded by someone other than the researchers (A and B) and then the capsules are given to patients. Until the end of the study and after analyzing the data, researchers will not know about the intervention and control groups.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2016-11-02, 1395/08/12
-
Ethics committee reference number
-
IR.MUMS.fm.REC.1395.102
Health conditions studied
1
-
Description of health condition studied
-
Hypertriglyceridemia
-
ICD-10 code
-
E78.1
-
ICD-10 code description
-
Pure hyperglyceridaemia
Primary outcomes
1
-
Description
-
Triglycerides
-
Timepoint
-
before the intervention
-
Method of measurement
-
enzymatic experimental kit
Secondary outcomes
1
-
Description
-
FBG
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
enzymatic experimental kit
2
-
Description
-
Insulin
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
radioimmunoassay experimental kit
3
-
Description
-
Total cholesterol
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
enzymatic experimental kit
4
-
Description
-
HDL-C
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
enzymatic experimental kit
5
-
Description
-
LDL-C
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
enzymatic experimental kit
6
-
Description
-
HS-CRP
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
ELISA experimental kit
7
-
Description
-
Body mass index
-
Timepoint
-
2 months after the intervention
-
Method of measurement
-
weight (kg) / height2 (m)
Intervention groups
1
-
Description
-
Intervention 1 The participants will be asked to take one capsule/day containing 100 mg curcuminoids and 200 mg bergamot, which was contained in an unlabeled for a period of 8 weeks.
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention 2
The placebo capsules containing lactose which will used orally for a period of 8 weeks. .
-
Category
-
Placebo
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
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
-
Amirhossein Sahebkar
sahebkara@mums.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
-
Comments
-