Protocol summary

Summary
Object of study: Determination the effect of Curcuma longa extract supplementation on metabolic parameters (lipid profile, blood glucose and insulin sensitivity) and anthropometric parameters in obese people.Study design: random, double blind, control with placebo, one research center. Study population: 70 obese subjects divided into 2 groups will receive turmeric extract (500 mg daily) and placebo control group (receiving 500 mg of starch per day). study groups will receive capsules for 90 days. Inclusion criteria: Willingness to cooperate, obese people with a body mass index over 30, age 20-65 years Exclusion criteria: Pregnancy and lactation, liver and kidney diseases, cancer, inflammation, digestive problems, special diet, hypo and hyper thyroid, recent surgery, anti coagulation, anemia, diabetes, allergies to the ginger family, turmeric and consumption of beverages alcohol, drugs and supplements for weight control and people with very low or high physical activity.first people will fill in Informed consent form,demographic and physical activity questioners and then randomly assigned to either the intervention group (receiving 500 mg extract ofturmeric) and control (receiving 500 mg of starch day).Both groups will receive 2 capsules for 90 days daily after meals. starch will be used as a placebo. height, weight, waist and hip in the beginning and end of the study will be measured.To measure the glucose, HbA1C, insulin, and lipid and lipoproteins, 5 mL of blood before and at the end of the period will be taken.Both systolic and diastolic blood pressure measurements at the beginning and end of the study will be conducted in all patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307082017N11
Registration date: 2013-07-16, 1392/04/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Sciences Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Survey of The Effect of Turmeric Total Extract Supplement on Metabolic and Anthropometric Factors in Obese Subjects
Public title
Survey of The Effect of Turmeric Total Extract Supplement on Metabolic and Anthropometric Factors in Obese Subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to cooperate, obese people with a body mass index over 30, age 20-65 years Exclusion criteria: Pregnancy and lactation, liver and kidney diseases, cancer, inflammation, digestive problems, special diet, hypo and hyper thyroid, recent surgery, anti coagulation, anemia, diabetes, allergies to the ginger family, turmeric and consumption of beverages alcohol, drugs and supplements for weight control and people with very low or high physical activity
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nutritionُ Sciences Reaserch Center - Tabriz University of Medical Sciences
Street address
Tabriz-Golgasht Avenue, Attar Neishaboori Street- Faculty of Nutrotion
City
Tabriz
Postal code
5166614711
Approval date
2013-04-29, 1392/02/09
Ethics committee reference number
9219

Health conditions studied

1

Description of health condition studied
obesity and lipid disorders
ICD-10 code
E65-E68
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
metabolic parameters
Timepoint
Before and three months after intervention
Method of measurement
Standard laboratory kits

2

Description
Anthropometric indices
Timepoint
Before and three months after intervention
Method of measurement
digital scales and standard meters

Secondary outcomes

1

Description
Measurement of blood pressure
Timepoint
Before and three months after intervention.
Method of measurement
sphygmomanometer in millimeters of mercury

Intervention groups

1

Description
Intervention group:2 pills containing 250 mg turmeric total extract for 3 months
Category
Treatment - Drugs

2

Description
control group: 2 pills containing 250 mg starch for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
The Clinics of Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Tabriz University Of Medical Sciences
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nutrition Scirnces Reaserch Center, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Scirnces Reaserch Center, Tabriz University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Ashrafnejad Asl
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ashrafnejadf@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Associate professor in Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
ostadrahimi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Fereshteh Ashrafnejad Asl
Position
MSc student in Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1380 9523
Fax
Email
ashrafnejadf@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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