Comparison of weight, BMI, fat mass, fat free mass, and waist circumference in each group and between study groups
Design
This study is a randomized controlled clinical trial with 2 groups. 80 patients will be randomly assigned into diet/placebo and diet/beautyslim.
Settings and conduct
Patients will be selected from individuals refer to Fayaz balkhsh Hospital day clinic. After assessing the inclusion criteria, information on demographic data and anthropometric measurements will be recorded. BMI will be calculated and body composition will be measured using BIA (a standard method for assessing body composition). The level of daily physical activity will be estimated using a standard physical activity questionnaire (MET) at the beginning and end of the study. Participants in both case and control groups will receive weight loss diets during the study period. To adjust the diet, after calculating the basal energy requirement individually, 500-300 calories will deduct from it and a calorie restricted diet will be given to participants. Depending on the group in which they are allocated, they will receive the supplement or placebo with the diet for 8 weeks. At the end of the 8th week, anthropometric indices will be assessed. In order to evaluate the patients' diet in terms of energy intake at the beginning and end of the study, a 3-day food recall will be completed for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: BMI>23.5, age: 20-64 years, Exclusion criteria: Having chronic or acute diseases, using weight reduction medication, substance overuse, pregnancy or lactation, using oral contraceptive
Intervention groups
Supplement group: Beauty slim supplement and weight reduction diet, Placebo group: placebo and weight reduction diet
Main outcome variables
weight; fat mass; fat free mass; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140804018677N10
Registration date:2021-08-04, 1400/05/13
Registration timing:registered_while_recruiting
Last update:2021-08-04, 1400/05/13
Update count:0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of beauty slim supplement compared to placebo on weight loss in adults with obesity or overweight
Public title
Beauty slim supplement and weight reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index>23.5
age of 20-64 years
Exclusion criteria:
Having chronic or acute illnesses
Consuming weight reduction medications
substance overuse
pregnancy or lactation
Consuming oral contraceptive
Age
From 20 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization method is used to randomize the patients. For randomization, we visited the www.sealedenvelope.com and used randomization tab to make a list considering the number of intervention groups, sample size, block size ( 4 is selected for current study). The prepared list that contains the pattern of patient allocation was obtained and will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code at the time of sampling. The following groups of people involved in the trial: participants, Research team including principle investigator, data collectors, and outcome assessors will be blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences
Street address
No. 5, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1028
Health conditions studied
1
Description of health condition studied
Overweight and Obese individuals
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Weight
Timepoint
Baseline and after 2 months from the beginning of the study
Method of measurement
Scale
2
Description
Fat mass
Timepoint
Baseline and after 2 months from the beginning of the study
Method of measurement
Omron BF511 body composition scale
3
Description
Fat free mass
Timepoint
Baseline and after 2 months from the beginning of the study
Method of measurement
Omron BF511 body composition scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: calorie restricted diet + beauty slim (dried green tea and Coriander) (Sun pharmed), for two months, three capsules daily
Category
Treatment - Other
2
Description
Control group: calorie restricted diet + placebo (Sun pharmed), For two months, three capsules daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayaz Bakhsh Hospital
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Deputy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Deputy, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razeghi Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data would be available to public
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
To all
Under which criteria data/document could be used
Have no other condition
From where data/document is obtainable
Email to soodehrazeghi@gmail.com
What processes are involved for a request to access data/document