Effects of Dried Extract of Glycyrrhiza Glabra Root with Weight Loss Diet on Anthropometric Indices, Vaspin Hormone, Zinc α2- glycoprotein and Lipid Profile in Obese Subjects
The aim of this study is to determine effects of dried extract of Glycyrrhiza Glabra root with weight loss diet on anthropometric indices, vaspin hormone, zinc α2- glycoprotein and lipid profile in obese subjects. In this study, 54 eligible subjects with body mass index equal or more than 25 will enter to the study and will be divided randomly into two intervention and placebo groups with 27 subjects. Participants will recieve one 500 mg capsule,3 times a day before meal for two months. Personality questionnaire, 24 hours food recall and international physical activity questionare will be filled from study subjects. For all of participants(intervention and placebo groups) weight loss diet with 500 Kcal reduction from their daily-needed amount of calorie will be desighned. The anthropometric measurements (weight,height,waist and hip circumferences) and biochemical measurements (lipid profile,vaspin and zinc alpha-2 glycoprotein) at baseline and the end of the study will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013062811288N3
Registration date:2013-08-29, 1392/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-29, 1392/06/07
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutrition Research Center, Health and Nutrition Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2013-04-19, 1392/01/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Dried Extract of Glycyrrhiza Glabra Root with Weight Loss Diet on Anthropometric Indices, Vaspin Hormone, Zinc α2- glycoprotein and Lipid Profile in Obese Subjects
Public title
Effects of Glycyrrhiza Glabra on Obese Subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: BMI equal or greater than 25; subjects with 25-50 years old;following no weight loss or any special diet during 6 months ago. Exclusion criteria: vitamin and mineral supplement consumption, losing weight drugs during 3 months age;pregnancy or lactation; smoking; 5-being hypertention,cardiovascular diseases,diabetes,liver,kindney,tyroid,types 1 or 2 diabetes
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
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
Ethics committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-07-22, 1392/04/31
Ethics committee reference number
9271
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Lipid profile mesearment
Timepoint
Beginning and the end of the intervention
Method of measurement
TC,TG,HDL-C,LDL-C mesearment with special kits
2
Description
Anthropometric indices
Timepoint
Beginning and the end of the intervention
Method of measurement
Weight,height,waist circumference and hip circumference mesearments
Secondary outcomes
1
Description
Vaspin hormone
Timepoint
Begining and the end of intervention
Method of measurement
ELISA method
2
Description
Zinc α2- glycoprotein
Timepoint
Begining and the end of intervention
Method of measurement
ELISA method
Intervention groups
1
Description
Intervention group:Consumption of 1.5 gr Glycyrrhiza Glabra Root supplement (500 mg capsules three times a day) with weight loss diet
Category
Treatment - Other
2
Description
Control group:1.5 gr starch(500 mg capsules three times a day) with weight loss diet
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheykholrais clinic
Full name of responsible person
Dr.Mohammad Alizadeh
Street address
Sheikhalrayis clinic, Golbad street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center, Health and nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Ostadrahimi
Street address
Block B, Third Floor, Health And Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street Tabriz, East Azerbayjan,Iran, Islamic Republic Of
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Health and nutrition faculty, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
PhD student of nutrition
Other areas of specialty/work
Street address
Block B, Third Floor, Health And Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
nazli.namazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)