The effects of slimming topical gel on anthropometric indices and body composition and biochemical factors in overweight and obese women: A double blind randomized controlled trial
The effects of slimming topical gel on anthropometric indices and body composition and biochemical factors in overweight and obese women: A randomized controlled study
Design
The study will be conducted on 30 obese and overweight women.
Settings and conduct
The study will be conducted at the Nutrition Research Center of Tabriz University of Medical Sciences and the duration of using slimming gel will be 8 weeks. The topical gels of the intervention and placebo groups will be coded by the person responsible for preparation, and the main researchers and patients will be blinded to the type of supplement consumed in each group.
Participants/Inclusion and exclusion criteria
inclusion criteria: women ,19-65 years old
body mass index above30 or above 27 with one or two risk factors like hypertension and type 2 diabetes.
exclusion criteria:consumption of weight loss drugs and supplements three months before the intervention
Hypothyroidism
heart disease
Taking high-dose oral corticosteroids
Pregnant and lactating women
Smoking and alcohol consumption
Intervention groups
3 groups of 10 people 1) topical use of gel Slimming for the entire abdominal circumference 2) Using slimming gel for half the abdominal circumference 3) Using Oserin as a placebo for the abdominal circumference
Main outcome variables
Anthropometric indices (Weight, Height, BMI, Waist circumference, Hip circumference, Waist to Hip Ratio)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002017N37
Registration date:2023-06-14, 1402/03/24
Registration timing:prospective
Last update:2023-06-14, 1402/03/24
Update count:0
Registration date
2023-06-14, 1402/03/24
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
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of slimming topical gel on anthropometric indices and body composition and biochemical factors in overweight and obese women: A double blind randomized controlled trial
Public title
The effects of slimming topical gel on overweight and obese women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
19-65 years old
body mass index above30 or above 27 with one or two risk factors like hypertension and type 2 diabetes
Exclusion criteria:
consumption of weight loss drugs and supplements three months before the intervention
Hypothyroidism
heart disease
Taking high-dose oral corticosteroids
Pregnant and lactating women
Smoking and alcohol consumption
Age
From 19 years old to 65 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
participants randomly using random block method and RAS (Random Allocation Software) and allocation ratio 1:1:1 and after equalization based on body mass index into 3 groups of 10 people 1) topical use of gel Slimming for the entire abdominal circumference 2) Using slimming gel for half the abdominal circumference 3) Using Oserin as a placebo for the abdominal circumference for 8 weeks
Blinding (investigator's opinion)
Double blinded
Blinding description
For all three study groups, the topical gel used will be the same in terms of shape, color and dosage. Participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded.
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
Vice Chancellor for Research and Technology,Golgasht St
City
tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.119
Health conditions studied
1
Description of health condition studied
obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Antropometric indices (Weight, Height, BMI, Waist circumference, Hip circumference, Waist to Hip Ratio)
Timepoint
Baseline and at the end of intervention
Method of measurement
Physical exam
Secondary outcomes
1
Description
body composition
Timepoint
baseline and after intervention
Method of measurement
tanita body composition analysis device
2
Description
Liver enzymes, BUN and creatinine
Timepoint
baseline and after intervention
Method of measurement
biochemical methods
3
Description
appetite
Timepoint
baseline and after intervention
Method of measurement
visual analog scale appetite
Intervention groups
1
Description
Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the whole abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet.
Category
Treatment - Drugs
2
Description
Intervention group: The intervention group will apply the topical jell every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet.
Category
Treatment - Drugs
3
Description
placebo group: The placebo group will apply the topical oserin every day for 8 weeks. The instruction to use the ointment will be applying 1 cc to the half of the abdominal area except around the belly button (i.e., 10 cm2) and to cover the area with a plastic sheet.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Research Center
Full name of responsible person
Dr.Alireza Ostadrahimi
Street address
Nutrition Research Center, Tabriz University of Medical Sciences; Attar Neishabouri Avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
ostadrahimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parviz SHahabi
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Street, Golgasht Avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Samira Pourmoradian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Faculty, Attar Neyshabouri Avenue, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
pourmoradians@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Data will be available 12 months after manuscript publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document