The effect of tripterygium wilfordii roots supplementation on the metabolic status, anthropometric parameters and serum levels of leptin and Chemerin in obese women
The purpose of this clinical trial is to evaluate the effect of tripterygium wilfordii roots supplementation on the metabolic status, anthropometric parameters and serum levels of leptin and Chemerin in obese women. Sample size is 44 person. This trial is a randomized, double-blind, placebo-controlled clinical trial. Blinding will be performed for patients and the study researchers. After meeting the inclusion and exclusion criteria, patients will allocated randomly (by random numbers table) into two intervention and control groups. At the beginning of the study, five ml of blood (after 8-12 hours of fasting) will be taken. After determining the persons to the intervention and control groups, a cloudy and closed envelopes will be used for allocation to two groups. For everyone in the envelopes, the capsule will be similar. 200 mg capsules with people on a daily basis will eat lunch. Fasting blood was used for lipid Parameters profile, leptin, insulin and Chemerin. Blood pressure also was measured.. They will be evaluated based on the following criteria: women 50-25 years of age and BMI of between 30- 40
Exclusion criteria: the use of lipid lowering agents; weight loss drugs and addiction
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610084105N29
Registration date:2017-07-01, 1396/04/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2017-07-11, 1396/04/20
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tripterygium wilfordii roots supplementation on the metabolic status, anthropometric parameters and serum levels of leptin and Chemerin in obese women
Public title
The effect of the tripterygium wilfordii on obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 25-50 year old women; BMI of between 30- 40; willingness to cooperate.
Exclusion criteria: use of lipid lowering agents; use of body weight loss medications; Addiction and Smoking; Menopause; Sensitivity to placebo; cancer; cardiovascular disease; liver disorders; kidney disease and anemia; use of antioxidant supplements, fish oil supplements and alcohol; pregnancy and lactation
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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 Sciences
Street address
Ghol-Ghasht Ave, Azadi St, Tabriz
City
Tabriz
Postal code
Approval date
2017-05-25, 1396/03/04
Ethics committee reference number
IR.TBZMED.REC.1396.179
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
HDL
Timepoint
At baseine and after 3 month of intervention
Method of measurement
Enzymatic and colorimetric method
2
Description
whight
Timepoint
At baseine and after 3 month of intervention
Method of measurement
scale
3
Description
LDL
Timepoint
At baseine and after 3 month of intervention
Method of measurement
Enzymatic and colorimetric method
4
Description
Triglyceride
Timepoint
Beginning of the study and after three months
Method of measurement
Enzymatic and colorimetric method
5
Description
Total Cholesterol
Timepoint
At baseine and after 3 month of intervention
Method of measurement
Enzymatic and colorimetric method
6
Description
Serum Chemerin
Timepoint
At baseine and after 3 month of intervention
Method of measurement
ELISA
7
Description
Serum Leptin
Timepoint
At baseine and after 3 month of intervention
Method of measurement
ELISA
8
Description
BMI
Timepoint
At baseine and after 3 month of intervention
Method of measurement
W/H.t2
9
Description
FBS
Timepoint
At baseine and after 3 month of intervention
Method of measurement
Glucose oxidase enzymatic and colorimetric
10
Description
Insulin levels
Timepoint
At baseine and after 3 month of intervention
Method of measurement
Enzymatically using autoanalyzer
11
Description
Insulin resistance
Timepoint
At baseine and after 3 month of intervention
Method of measurement
HOMAIR
Secondary outcomes
1
Description
Food intake
Timepoint
At baseine of the study, sixth week and three months later
Method of measurement
The questionnaires and Software nutrition 4
2
Description
blood pressure
Timepoint
At baseine of the study, sixth week and three months later
Method of measurement
Standard mercury manometer
3
Description
Physical activity
Timepoint
At baseine of the study, sixth week and three months later
Method of measurement
The International physical activity questionnaire
Intervention groups
1
Description
Intervention group: patients will recieve a daily capsule containing 200 mg of tripterygium wilfordii root poweder, for three months. Capsules should taken with food and a glass of water.
Category
Treatment - Drugs
2
Description
Control group: patients will receive a placebo capsule, daily for three months..
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of nutrition Kermanshah University of Medical Sciences
Full name of responsible person
Dr mostafa nachvak
Street address
Faculty of nutrition Kermanshah University of Medical Sciences, Dolatabad, Isar Sq, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi, Research Assistant of Tabriz University of Medical Sciences
Street address
Ghol-Ghasht Ave.,Azadi St.,Tabriz.
City
Tabriz
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, 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
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mousavi Mele
Position
MSc. Student of Nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave.,Azadi St.,Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
mahdijj8730@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mousavi Mele
Position
msc.student of nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave., Azadi St.,Tabriz.
City
Tabriz
Postal code
00984133357581
Phone
+98 41 3335 7581
Fax
Email
mahdijj8730@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Mahdi Mousavi Mele
Position
MSC student of nutrition
Other areas of specialty/work
Street address
Ghol-Ghasht Ave., Azadi St.,Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3335 7581
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)