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Study of the effect of nanomicelles curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome

Protocol summary

Study aim
Determination of the effect of supplementation with nanomicelles curcumin on glycemic control, serum lipid profile, blood pressure and anthropometric indices in patients with metabolic syndrome
Design
Double-blind randomized clinical trial with parallel groups
Settings and conduct
Patients with metabolic syndrome referring to the endocrine clinic of Shohadaye yaft abad and Pars hospital, who have criteria for entering the study, will be aware of the method and goals of the study and each patient will write informed consent if they have a tendency to participate in the study. At the start and after the end of the intervention, 10 cc blood will be taken from patients after 12-14 hours fasting .At baseline Their height and weight will be measured.Then, in order to control the confounding factors , they will be randomly assigned to nanomicelles curcumin and placebo group. Patients in nanomicelles curcumin group will received a 80 mg capsule daily and patients in placebo group will received a placebo capsule daily for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: -Tendency for cooperation -Age between 18-70 years old -BMI between 25-40 kg/m2 -Having metabolic syndrome according to NCEP ATP III criteria( if 3 or more of five criteria are met) Exclusion criteria: -Pregnancy -Lactation -Insulin therapy -Having thyroid dysfunction -Having kidney disease -Having unusual diet -Use fat burner and weight lose drug
Intervention groups
Each patient will write informed consent if they have a tendency to participate in the study. After randomization, patient in study group will receive a capsule of nanomicelles curcumin daily and patient in control group will receive placebo capsule daily for 12 weeks.
Main outcome variables
Fasting blood glucose, insulin, hemoglobin A1c, total cholesterol, LDL-C and HDL-C, triglyceride, blood pressure, HOMA-IR, HOMA-B

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150815023617N3
Registration date: 2018-06-25, 1397/04/04
Registration timing: registered_while_recruiting

Last update: 2018-06-25, 1397/04/04
Update count: 0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 22077424
Email address
golbonsohrab@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-30, 1397/03/09
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of nanomicelles curcumin on glycemic control, serum lipid profile ,blood pressure and anthropometric measurements in patients with metabolic syndrome
Public title
nanomicielles curcumin in metabolic syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency for participation Age between 18-70 years old BMI between 25-40 kg/m2 Having metabolic syndrome according to the NCEP ATP III definition(if patient have three or more of the following five criteria): waist circumference over 120 cm (men) or 89 cm (women), blood pressure over 130/85 mmHg, fasting triglyceride (TG) level over 150 mg/dl, fasting high-density lipoprotein (HDL) cholesterol level less than 40 mg/dl (men) or 50 mg/dl (women) and fasting blood sugar over 100 mg/dl.
Exclusion criteria:
Pregnancy Lactation Use insulin injection Thyroid disorder Henal disease Having unusual diet during 3 last month Use weight loss and fat burner drugs
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 21
Randomization (investigator's opinion)
Randomized
Randomization description
Supplements and placebo will be identified with codes A, B, and researchers do not know how the codes will be distributed. Then, from the table of four blocks(A and B), 13 blocks will be randomly selected, and these blocks will be placed behind each other. Then, 25 envelopes will be provided and the name of the group A or B put in each envelope . These envelopes will be referred to individuals, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo will be identified with codes A, B, and researchers do not know how the codes will be distributed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2018-04-13, 1397/01/24
Ethics committee reference number
IR.SBMU.nftri.Rec.1396.207

Health conditions studied

1

Description of health condition studied
Metabolic syndrom
ICD-10 code
E88.81
ICD-10 code description
Metabolic syndrome

Primary outcomes

1

Description
homeostatic model assessment of insulin resistance(HOMA-IR)
Timepoint
Baseline and end of the study
Method of measurement
Calculation :(glucose×Insulin)/22.5

2

Description
homeostatic model assessment of B-cell function(HOMA-B)
Timepoint
Baseline and end of the study
Method of measurement
Calculation

3

Description
Hba1c
Timepoint
Baseline and end of the study
Method of measurement
ion-exchange chromatography

4

Description
Serum glucose
Timepoint
Baseline and end of the study
Method of measurement
Colorimetric analysis method

5

Description
Serum insulin
Timepoint
Baseline and end of the study
Method of measurement
ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Each capsule contains 80 mg nanomicielles curcumin. Use once a day for 12 weeks.
Category
Treatment - Other

2

Description
Control group: Each capsule contains yellow colour(E104) and lecithin. Use once a day for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye yaft abad hospital and Pars hospital
Full name of responsible person
Golbon Sohrab
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0656
Email
golbonsohrab@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
assistant of of Research and Technology of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
golbonsohrab@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Bateni
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0656
Email
zohre.bateni@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golbon Sohrab
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2207 7424
Fax
+98 21 2236 0657
Email
golbonsohrab@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Bateni
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2236 0656
Email
zohre.bateni@yahoo.com

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
Only part of the data is shared, such as the original outcome.
When the data will become available and for how long
The start of the access period is 12 months after printing the results.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The documentation can only be used for more detailed studies in this field.
From where data/document is obtainable
golbonsohrab@sbmu.ac.ir zohre.bateni@yahoo.com
What processes are involved for a request to access data/document
The communication will be possible through the electronic mail given in the previous section.
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