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The effect of curcumin-piperine dietary supplement on lipid profile, glycemic, inflammatory and blood pressure indicators in people with type 2 diabetes and hypertriglyceridemia: randomized double-blind clinical trial

Protocol summary

Study aim
the effect of curcumin-piperine dietary supplement on lipid profile, glycemic, inflammatory and blood pressure indicators in people with type 2 diabetes and hypertriglyceridemia: randomized double-blind clinical trial
Design
The double-blind, phase 3 and randomized trial will be divided into two groups of 40 people (intervention group and placebo) using a random number table.
Settings and conduct
We select 80 people with type 2 diabetes with hypertriglyceridemia who go to clinics affiliated to Isfahan University of Medical Sciences and randomly divide them into two groups: supplement and placebo. For the purpose of blindness, the drug and the placebo will be very similar and participants and researchers will not be aware of it until the end of the study. Biochemical evaluation, anthropometry and measurement of blood pressure and blood test are performed at the beginning of the study and 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study; age 18-65 years old; diagnosed with type 2 diabetes (fasting blood sugar above 126 mg / dL); hypertriglyceridemia (triglyceride above 150 mg / dL). Exclusion criteria: pregnancy or lactation; people with type 1 diabetes and diabetes insipidus; insulin injection; smoking; heart disease, lung disease, kidney disease, malignant cancer, immune system disorders, addiction or sever disease; unwillingness to continue cooperation; observation of any side effects; creating any of the conditions of non-inclusion during the study and taking less than 90% of curcumin supplement.
Intervention groups
Take one 500 mg curcumin-piperine tablet daily for 12 weeks. Placebo group: Take one placebo tablet daily for 12 weeks
Main outcome variables
Lipid profile (HDL, LDL, TG, Tch); fasting blood sugar (FBS); weight, height, waist circumference, BMI; blood pressure; insulin level; CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121216011763N50
Registration date: 2021-02-16, 1399/11/28
Registration timing: registered_while_recruiting

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-10, 1399/09/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine dietary supplement on lipid profile, glycemic, inflammatory and blood pressure indicators in people with type 2 diabetes and hypertriglyceridemia: randomized double-blind clinical trial
Public title
The effect of curcumin-piperine dietary supplement in people with type 2 diabetes and hypertriglyceridemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study Age: 18-65 years old Type 2 diabetes (fasting blood sugar above 126 mg / dL) Hypertriglyceridemia (triglyceride above 150 mg / dL) has been diagnosed.
Exclusion criteria:
Pregnancy and lactation People with type 1 diabetes and tasteless diabetes Insulin injection Smoking Heart, lung, kidney, malignant cancer, immune system disorders, addiction or mental illness
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into two groups of intervention and placebo by simple random sampling and will be studied for 12 weeks. First, the list of patients who are admitted according to the inclusion criteria is prepared with the cooperation of the design specialist. Then, a code is assigned to each person and patients are divided into two groups of intervention and control using a table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to conduct this research in a double-blind manner, before starting the study, the relevant capsules are coded in A and B by a person other than the researcher, so that the researcher does not know the type of capsules received by both participants and researchers.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.578

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Serum lipids
Timepoint
Blood samples are taken at the beginning and end of the study
Method of measurement
Blood samples

2

Description
Blood glucose
Timepoint
Blood samples are taken at the beginning and end of the study
Method of measurement
Blood samples

Secondary outcomes

1

Description
Cholesterol
Timepoint
Before and after the intervention
Method of measurement
Blood samples using enzymatic methods

2

Description
High-density lipoprotein (HDL)
Timepoint
Before and after the intervention
Method of measurement
Blood samples using enzymatic methods

3

Description
Low density lipoprotein (LDL)
Timepoint
Before and after the intervention
Method of measurement
Blood samples using enzymatic methods

4

Description
Inflammatory factor (hs-CRP)
Timepoint
Before and after the intervention
Method of measurement
Blood samples using enzymatic methods

Intervention groups

1

Description
Intervention group: will receive one capsule daily (containing 495 mg of curcumin extract + 5 mg of piperine) along with diet and exercise recommendations. The supplement is from Sami labs Ltd., India and is used for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: they will receive one placebo capsule daily, along with diet and exercise recommendations. The placebo is purchased from Sami labs Ltd., India and consumed for 12 weeks. Capsules are exactly the same in type, color, shape and size (appearance).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The endocrine and metabolism research center, Isfahan University of Medical Sciences.
Full name of responsible person
Dr. Gholamreza Askari
Street address
Department of Community Nutrition, School of Nutrition and Food sciences, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou
Street address
Isfahan, Hezargarib street, Esfahan university of medical sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Askari
Position
MD & PhD (Nutritionist)
Latest degree
Specialist
Other areas of specialty/work
Nutrition
Street address
Hezarjirib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
askari@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
Dr. Gholamreza Askari
Position
Ph.D of nutrition, Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Ph.D of nutrition, Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Department of Community Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data can be shared after making people inaccessible
When the data will become available and for how long
One year after the results are published
To whom data/document is available
Researchers and academic and research institutes
Under which criteria data/document could be used
The data will be made available for research purposes and care must be taken to preserve that information
From where data/document is obtainable
Hezar Jerib St. Isfahan University of Medical Sciences Faculty of Nutrition and Food Sciences Dr. Gholamreza Askari ASKARI@MUI.AC.IR
What processes are involved for a request to access data/document
Submit your application via email to be sent if you agree ASKARI@MUI.AC.IR
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