Effect of ginger (zingiber officinale Roscoe) supplementation on nutritional status and circulating levels of some adipocytokines in obese women with regard to genetic polymorphism of UCP-1, leptin, adiponectin and beta 3 adrenergic receptors
(1) Objectives: Effect of ginger (zingiber officinale Roscoe) supplementation on nutritional status and circulating levels of some adipocytokines in obese women with regard to genetic polymorphism of UCP-1, leptin, adiponectin and beta 3 adrenergic receptors. (2) Design: Double blind randomized clinical trial. (3) Setting and conduct: 80 eligible obese women which meet the inclusion criteria during a general call will be selected and randomly divided into two groups: intervention (ginger) and control (placebo). (4) Participants including major eligibility criteria: Obese volunteer women (30 ≤ BMI ≤ 40) in the age group 18-48 years without any exclusion criteria including: Pregnancy; Lactation; Menopause; Being under weight loss diets at now or in the past 3 months; Vigorous physical activity; History of diabetes; Cardio- vascular disease; Hypo or hyperthyroidism; Gall stones; Deep depression; Constantly use of medications such as Propranolol or other beta-blockers, Warfarin, Corticosteroids; Any history of allergy to ginger; Constantly taking vitamin supplements or ginger at now or in the past 3 months; Smoking. (5)Intervention: intervention group (receiving 2 grams per day of powdered ginger as 2 tablets, before meals for 3 months) and control group (receiving 2 g corn starch as 2 placebo tablets, before meals for 3 months). (6) Main outcome measures: Anthropometric measurements (weight, BMI, waist and hip circumference) ; Body composition; Appetite; Energy and nutrient intake; Determining genetic polymorphism of UCP-1, leptin, adiponectin and beta 3 adrenergic receptors genes; Serum levels of leptin, adiponectin and resistin ;Serum levels of total antioxidants and malondialdehyde.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311172017N18
Registration date:2014-01-22, 1392/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-22, 1392/11/02
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 Research Center, Tabriz University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ginger (zingiber officinale Roscoe) supplementation on nutritional status and circulating levels of some adipocytokines in obese women with regard to genetic polymorphism of UCP-1, leptin, adiponectin and beta 3 adrenergic receptors
Public title
Effect of ginger (zingiber officinale Roscoe) supplementation on nutritional status and circulating levels of some adipocytokines in obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were:
Obese women (30 ≤ BMI ≤ 40) in the age group 18-48 years.
Exclusion criteria were:
Aged under 18 or over 48; Pregnancy; Lactation; Menopause; Being under weight loss diets at now or in the past 3 months; Vigorous physical activity; History of diabetes; Cardio- vascular disease; Hypo or hyperthyroidism; Gall stones; Deep depression; Constantly use of medications such as propranolol or other beta-blockers, warfarin, corticosteroids; Any history of allergy to ginger; Constantly taking vitamin supplements or ginger at now or in the past 3 months; Smoking.
Age
From 18 years old to 48 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed by permuted block randomization (block size: 4) using RAS software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht street- Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-12-19, 1392/09/28
Ethics committee reference number
92154
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
Anthropometric measurements
Timepoint
4 times during the study: at the beginning and end of each intervention month
Method of measurement
Anthropometric measurements including weight using calibrated Seca scale with a precision of 0.1 kg and a minimum of clothes in the morning, height, waist and hip circumference using a tape measure with an accuracy of 0.1 cm, and BMI and waist-hip ratio was calculated.
2
Description
Body composition
Timepoint
4 times during the study: at the beginning and end of each intervention month
Method of measurement
Measurement of body composition, including fat mass, fat free mass and total body water determination using Bioelectric Impedance Analyzer ( BIA).
3
Description
Appetite
Timepoint
4 times during the study: at the beginning and end of each intervention month
Method of measurement
using 5 items questionnair based on the VAS scale
4
Description
Energy and nutrient intake
Timepoint
3 times; at first, midst and the end of intervention
Method of measurement
3 dayes food record was used and analyzed with Nutritionist 4 software
5
Description
Serum levels of leptin, adiponectin and resistin
Timepoint
Befor and after intervention
Method of measurement
By Laboratory ELISA Kits
6
Description
Serum levels of total antioxidants and Malondialdehyde
Timepoint
Before and after intervention
Method of measurement
TAC: Enzymatic method by commercial kits; MDA: Reaction with thiobarbituric acid by fluorimetry method
7
Description
Determining genetic polymorphism of UCP-1, leptin, adiponectin and beta 3 adrenergic receptors genes
Timepoint
At first- as a independent variable
Method of measurement
RFLP-PCR
Secondary outcomes
1
Description
Fasting blood suger
Timepoint
Before and after intervention
Method of measurement
Enzymatic method
2
Description
Serum level of Insulin
Timepoint
Before and after intervention
Method of measurement
ELISA
3
Description
Serum Lipid profile
Timepoint
Before and after intervention
Method of measurement
Enzymatic method for total cholesterol, triglyceride and HDL.cand Freidwald’s formula for LDL.c
Intervention groups
1
Description
Intervention group: 2 grams powdered dry ginger as 2 tablets per day for 90 day
Category
Treatment - Drugs
2
Description
Control group: 2 grams powdered corn starch as 2 tablets per day for 90 day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Vahideh Ebrahimzadeh Attari
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nutrition Research Center, Tabriz Univercity of Medical Science
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Golgasht Street, Attar neishaboori Avenue, Nutrition Research Center, 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 Research Center, Tabriz Univercity of Medical Science
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
Vahideh Ebrahimzadeh Attary
Position
Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Golgasht Street, Attar Neyshaboori Avenue, Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 2292
Fax
+98 41 1335 7584
Email
ebrahimzadeh.va@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
Alireza Ostadrahimi
Position
Associate professor
Other areas of specialty/work
Street address
Faculty of Nutrition, Golgasht Street, Attar neishaboori Avenue
City
Tabriz
Postal code
Phone
+98 41 1335 2295
Fax
Email
ostadrahimi@tbzmed.ac.i
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
Vahideh Ebrahimzadeh Attari
Position
Ph.D Student of Nutrition
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7584
Fax
+98 41 1335 7584
Email
ebrahimzadeh.va@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)