Comparing the changes of body mass index (BMI) and anthropometric measures at the onset of the study, 6 and 12 weeks after treatment. This clinical trial is performed in Guilan Pain Clinic on subjects whom are visited for weight loss or any other purpose. After obtaining a history, physical exam and 12 lead ECG, venous blood is obtained for baseline biochemical serum measurements, as well as CBC- ALT- AST- BUN- Cr-ALKP. The inclusion criteria are patients aged between 18-55 years old; BMI between 24 and 35 kg/m2; low tea consumption (<2 tea bags/day or <4 g loose tea/day). The exclusion criteria; competitive athletes; smokers; use of any medication, apart from over the counter and oral contraceptives; suffering from any medical or psychiatric condition; actively following a weight loss regimen or a medically prescribed dietary regime; losing or gaining >2 kg body weight in the 3 months before the start of the trial; pregnancy and breast feeding. All participants meeting inclusion criteria provide with informed consent and are randomly assigned to two groups of green tea(n=30) and placebo(n=30) by triple blocks. Subjects in green tea group receive a cup of green tea 1 hour before breakfast and lunch. At the onset of the study and after 6 and 12 weeks BMI and anthropometric measures are measured by a person who is not aware from the type of drink. Then the results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504086186N10
Registration date:2015-04-23, 1394/02/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-04-23, 1394/02/03
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-05-23, 1394/03/02
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green tea on BMI and anthropometric measures
Public title
Effect of green tea on BMI and anthropometric measures
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: the patient aged between 30-65 years old candidate for tibia fracture surgery; daily consumed of black tea are not more than 3 tea bags or 4 diluted ones.The exclusion criteria are cognitive or psychiatric disorders; history of any drug abuse; hepatic and renal diseases; pregnancy and breast feeding.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Triple blocks randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
1930596706
Health conditions studied
1
Description of health condition studied
Body Mass Index
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body Mass Index
Timepoint
Baseline ,6 and 12 weeks after treatment
Method of measurement
Kg/m2
2
Description
Anthropometric measures
Timepoint
Baseline ,6 and 12 weeks after treatment
Method of measurement
Cm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: An opaque straw cup with containing 100 cc of green tea which is prepared by a tea bag containing 2 gr of green tea in 80 cc water for 2 minutes. It is prescribed 1 hour before breakfast and lunch.
Category
Treatment - Other
2
Description
Intervention 2: an opaque straw cup with containing 100 cc of warm water. It is prescribed 1 hour before breakfast and lunch.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Bahram Naderi Nabi
Street address
Porsina Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)