Effects of Nigella Sativa Oil Suplementation with Weight Loss Diet on Some Anthropometric Indices, Lipd Profile and Some Inflammatory Factors in Obese Women with Various Polymorphisms of Adiponectin gene and Type 2 Isoform Peroxisome proliferator-activated receptor gamma
(1)Objectives: Effects of Nigella Sativa oil suplementation with weight loss diet on some anthropometric indices, lipid profile and some inflammatory factors in obese women with various polymorphisms of adiponectin and PPARγ2 genes. (2)Design: Double blind randomized clinical trial. (3)Setting and conduct: 82 eligible women with body mass index 30-34.9 kg/m2 randomly(with random number table) will be divided into two intervention(Nigella Sativa oil) and placebo(sunflower oil) groups. (4)Participants including major eligibility criteria: women with 25-50 years old; Body Mass Index between 30 to 34.9 kg/m2; following no weight loss diet or any special diet during 6 months ago. (5)Intervention: Intervention group: 3gr/day Nigella Sativa oil as 3 capsules of 1000 mg and control group: 3gr/day sunflower oil as 3 capsule of 1000 mg for two months. Also all participants will receive weight loss diet with 500 Kcal less than their daily-needed amount of calorie. (6) Main outcome measures: Anthropometric measurements (weight,height, waist circumference and hip circumference); Lipid profile including: Cholesterol (TC), Triglycerides(TG), Low-density lipoprotein (LDL-c), High-density lipoprotein (HDL-c); Inflammatory factors including Interleukin-6(IL-6), Tumor necrosis factor-alpha (TNF-alpha) and hs-CRP; Dietary intake (24-Hours food recall for two worked days and 1 holiday); distribution and frequency of adiponectin and Peroxisome proliferator-activated receptor gamma-2 isoform.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106191197N10
Registration date:2013-12-17, 1392/09/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-17, 1392/09/26
Registrant information
Name
Reza Mahdavi
Name of organization / entity
Faculty of Health & Nutrition, Tabriz UniV. of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7584
Email address
mahdavir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences and Nutrition Research Center of Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Nigella Sativa Oil Suplementation with Weight Loss Diet on Some Anthropometric Indices, Lipd Profile and Some Inflammatory Factors in Obese Women with Various Polymorphisms of Adiponectin gene and Type 2 Isoform Peroxisome proliferator-activated receptor gamma
Public title
Effects of Nigella Sativa in Obese Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with 25-50 years old; Body Mass Index between 30 to 34.9 kg/m2; following no weight loss diet or any special diet during 6 months ago. Exclusion criteria: taking vitamin-mineral supplement during 3 months ago;taking anti-inflammatory medications, losing weight drugs, asprin and other anticoagulant medications; cardiovascular diseases, liver, kidney and tyroid disorders,type 1 or 2 diabetes; pregnancy and lactation; smoking
Age
From 25 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
82
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: 2) using RAS software.
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, Attar Neyshaboori Street
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
92126
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 indices
Timepoint
Beginning and at the end of the intervention(after 2 months)
Beginning and at the end of the intervention( after 2 months)
Method of measurement
Measurement of IL-6,TNF-α and hs-CRP with special kits
3
Description
Lipid profile
Timepoint
Begining and at the end of study(2 months)
Method of measurement
Measurment of HDL-C,LDL-C,TG,TC with special kits
Secondary outcomes
1
Description
Frequency of adiponectin and PPAR gamma-2 genotypes
Timepoint
Begining of intervention
Method of measurement
PCR-RFLP
Intervention groups
1
Description
Intervention group: Comsumption of 3 gr/day Nigella Sativa oil provided by Daana pharmaceutical company(1 gr soft gel capsule 3 times a day) with weight loss diet for 2 months
Category
Other
2
Description
Control group: 3 gr/day sunflower oil provided by Daana pharmaceutical company(1 gr soft gel capsule 3 times a day) with weight loss diet
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhoraeese clinic
Full name of responsible person
Dr. Mohammad Alizadeh
Street address
Sheikhorayis clinic, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz Uniersity of Medical Sciences
Full name of responsible person
Dr. Reza Rashidi
Street address
Tabriz University Of Medical Sciences , Attar Neyshabori Street, 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 of Tabriz Uniersity of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Nutrition Research Center
Full name of responsible person
Dr. Alireza Ostadrahimi
Street address
Block B, Third Floor, Health And Nutrition Faculty, Tabriz University Of Medical Sciences , Attar Neyshabori Street Tabriz
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
Proportion provided by this source
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, Health and nutrition faculty
Full name of responsible person
Nazli Namazi
Position
Ph.D student of nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
nazli.namazi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Research Center, Health and nutrition faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Mahdavi
Position
PhD of nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1334 1113
Fax
Email
mahdavir@tbzmed.ac.ir;nazli.namazi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health and Nutrition Faculty,Tabriz University of Medical Sciences
Full name of responsible person
Nazli Namazi
Position
Ph.D student of nutrition
Other areas of specialty/work
Street address
Health and Nutrition Faculty,Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 1335 2292
Fax
+98 41 1335 2292
Email
nazli.namazi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)