According to the World Health Organization definition, overweight & obesity are abnormal accumulation of more body fat mass that impair health. Overweight & obesity lead to detrimental metabolic effects on blood pressure, cholesterol, triglycerides & insulin resistance. Obesity especially visceral obesity leads to changes in inflammatory factors that originated from the alterations of cell function in adipose tissue & macrophages. Cellulite is one of the complications of obesity. Cellulite is a fibrous connective tissue. Today, there are devices that emit energy to subcutaneous fat layer of the skin selectively with a aim of improving cellulite and changes in body shape . The aim of this study is reduction of body size, improving lipid profile and inflammatory factors with the assistance of local slimming machine called Majic Pot & Megason. Majic Pot is advanced localized fat reduction system that we have used Radio frequency technology of this device in this project. Transmission of radio waves to adipose tissue stimulate Lipolysis & damaging fat cells. Its Temperature is 50-60 °C. These waves induce the transmission of electromagnetic waves to tissue, renew of old collagen, increase the production of new collagen by stimulating fibroblasts. Megason is another local slimming system that with the assistance of ultrasound tech at 30-70 KHz frequency range, create a negative pressure in the tissue, an increase in the size of fat cells & create vibrations destroy fat cells which are excreted through the lymphatic system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042817475N1
Registration date:2014-06-09, 1393/03/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-09, 1393/03/19
Registrant information
Name
Mahsa Mohammadzadeh
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 7033
Email address
mohammadzm913@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Radio frequency and Cavitation on Biochemical Markers and Body Contouring in Overweight People
Public title
Evaluating the effect of Radio frequency and Cavitation on Biochemical Markers and Body Contouring in Overweight People
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Overweight Women aged between 18 to 65 years; no use of certain drug like the drugs that Reduce sensitivity local steroid neuro drugs in the past six months; no medical history of Cardiovascular disease and Diabetes; not be pregnant and Breastfeeding; BMI between 25 to 30 kg/m2; Not having Cardiac pacemaker.
Exclusion criteria: Pregnancy and Lactation; Age under 18 years or above 65 years; Male gender; Skin infection; Skin sensitivity to sunlight; use of topical steroids; Not being agree to continue working; People with type 1 and type 2 Diabetes; Systemic disease; not having weight reduction diet in the past three months; Having Cardiac pacemaker; BMI over 30 kg/m2 and less than 25 kg/m2
Before starting intervention, during the intervention, at the end of period of intervention
Method of measurement
Tanita body composition analyzer
2
Description
Waist circumference
Timepoint
Before starting intervention, during the intervention, at the end of period of intervention
Method of measurement
Non elastic meter in terms of centimeter
3
Description
Abdominal circumference
Timepoint
Before starting intervention, during the intervention, at the end of period of intervention
Method of measurement
Non elastic meter in terms of centimeter
4
Description
Hip circumference
Timepoint
Before starting intervention, during the intervention, at the end of period of intervention
Method of measurement
Non elastic meter in terms of centimeter
5
Description
Waist to Hip circumference
Timepoint
Before starting intervention, during the intervention, at the end of period of intervention
Method of measurement
Non elastic meter in terms of centimeter
6
Description
Totall cholesterol
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
7
Description
Improvement of Cellulite
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Nurnberger- Muller score
8
Description
Blood pressure
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Sphygmomanometer
9
Description
LDL-C
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
10
Description
HDL-C
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
11
Description
TG
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
12
Description
Fasting Blood Sugar (FBS)
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
13
Description
Pro oxidant Antioxidant Balance
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Spectrophotometric
14
Description
Interleukin-1α
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
15
Description
Interleukin-1β
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
16
Description
Interleukin-2
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
17
Description
Interleukin-4
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
18
Description
Interleukin-6
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
19
Description
Interleukin-10
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
20
Description
Tumour Necrosis Factor Alpha
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
21
Description
Interferon Gamma
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
22
Description
Epidermal Growth Factor
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
23
Description
Vascular Endothelial Growth Factor
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
24
Description
Monocyte Chemoattractant Protein-1
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
25
Description
Interleukin-8
Timepoint
Before starting intervention, at the end of period of intervention
Method of measurement
Enzyme-Linked Immunosorbent Assay (ELISA)
Secondary outcomes
empty
Intervention groups
1
Description
In the case group, working with local slimming machine for five weeks with two sessions per week (overally, 10 sessions that will have a working session with Majic Pot and a working session with Megason) Each session lasts 40 minutes. Diet to lose weight with 500 kilocalories reduction was given at the same time.
Category
Treatment - Devices
2
Description
A diet to lose weight with 500 kilocalories reduction in order to lose weight was given to the control group for five weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Special clinic of Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Abdolreza Norouzy
Street address
Nutrition Department of Medical College, Vakilabad Blvd
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Abdolreza Norouzy
Position
Assistant Professor
Other areas of specialty/work
Street address
Nutrition Department of Medical College,Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 1800 2382
Fax
Email
norouzyA@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Abdolreza Norouzy
Position
Assistant Professor
Other areas of specialty/work
Street address
Nutrition Department of Medical College, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 1800 2382
Fax
Email
norouzyA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Mohammadzadeh
Position
Master of Science Student
Other areas of specialty/work
Street address
Nutrition Department of Medical College, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 1882 7033
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)