Protocol summary

Study aim
The effect of Curcumin, Coenzyme Q10 and Their Combinations on Metabolic Syndrome Components in soldiers with Metabolic Syndrome
Design
this study was performed as randomized, parallel controlled clinical trial on 88 patients with Metabolic Syndrome
Settings and conduct
this study was performed as randomized, parallel controlled clinical trial on 88 patients with Metabolic Syndrome. In this study, while receiving written informed consent from patients, participants were blinded to receiving drugs and placebo.
Participants/Inclusion and exclusion criteria
The age range for the current study is between 30 and 50 years, and based on the age range of 30 to 50 years old, IDF has a waist circumference of more than 94 cm and 2 criteria of 4 The following criteria will be diagnosed with metabolic syndrome: fasting blood glucose greater than 100 mg / dL, triglyceride greater than 150 mg / dL, blood pressure greater than 130/85 mm Hg, and lower HDL From 40 mg / dl
Intervention groups
Patients were divided into three groups of intervention and one contorol group. The intervention group with curcumin, The intervention group with CoQ10, The intervention group with curcumin and CoQ10 and placebo group
Main outcome variables
indicators of profail lipidi(tg-chol-hdl-ldl) indicators of antropometric(bmi-waist-wighet) fasting blood suger blood perser systolic ,blood perser diystolic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180201038585N2
Registration date: 2018-09-21, 1397/06/30
Registration timing: registered_while_recruiting

Last update: 2018-09-21, 1397/06/30
Update count: 0
Registration date
2018-09-21, 1397/06/30
Registrant information
Name
Karim Parastouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 3516
Email address
parastouei@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-19, 1397/04/28
Expected recruitment end date
2018-12-28, 1397/10/07
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
empty
Scientific title
The effect of curcumin, coenzyme Q10 and their combined effects on metabolic syndrome components in soldiers with metabolic syndrome
Public title
Effect of curcumin, coenzyme Q10 and their combined effects on metabolic syndrome components in soldiers with metabolic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: 30 -50 years military personnel with metabolic syndrome
Exclusion criteria:
the use of statins in the last 3 months having a history of cardiovascular disease morbility liver, kidney Consumption alcohol and smoking supplementation and certain drugs people who have taken less than 80% of the capsules containing curcumin, quinidine Q10 and placebo.
Age
From 30 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 88
Actual sample size reached: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method has been used
Blinding (investigator's opinion)
Double blinded
Blinding description
Intervention and randomization through a random allocation list was made by a member of the research team as the only non-blind person to be assigned. Other team members (including team leader and study cordinator) as well as all participants, were randomly allocated to blind groups and remained blind 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 of bahgeyatlah University of Medical Sciences
Street address
Vanak - Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.Bmsu.rec.1397.449

Health conditions studied

1

Description of health condition studied
Metabolic syndrome
ICD-10 code
E00-E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases

Primary outcomes

1

Description
waist circumferefnce
Timepoint
before intervention and end of intervention
Method of measurement
measuring tape

2

Description
fasting blood sugar
Timepoint
before intervention and end of intervention
Method of measurement
lab kit

3

Description
Triglyceride
Timepoint
before intervention and end of intervention
Method of measurement
lab kit

4

Description
cholesterol
Timepoint
before intervention and end of intervention
Method of measurement
lab kit

5

Description
blood presure
Timepoint
before intervention and end of intervention
Method of measurement
sphygmomonometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1, curcumine 500mg, Every other day, Karen co.
Category
Treatment - Drugs

2

Description
Intervention group: 2, CoQ10, 60mg, once a ,day , nature made
Category
Treatment - Drugs

3

Description
Intervention group:3, combination of (curcumine 500mg, Every other day, CoQ10, 60mg, once a ,day)
Category
Treatment - Drugs

4

Description
Control group: placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Health, Assistance and Treatment of Police
Full name of responsible person
javad mirahmadi
Street address
Department of Health, Assistance and Treatment of Police, Enghelab square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 6398 2262
Email
javadmirahmadinut@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Alishir
Street address
Mollasadra St, Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8248 3516
Email
javadmirahmadinut@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Street Vanak - Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
karimparastouei@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
ترجمه خیابان ونک - خیابان ملاصدرا 27/5000 Street Vanak - Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
karimparastouei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
karim parastouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Street Vanak - Mulla Sadra Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8248 3264
Email
karimparastouei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of the confidentiality of the information on the civilians
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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