Formulation of ِDietary Supplement Using Collagen, Ornithine and Probiotic and its Evaluation on Skin Health Factors in Healthy People: A Double-Blind Randomized Controlled Trial
Design of dietary supplement containing collagen, ornithine and probiotics and its evaluation on skin health indicators in two groups of intervention and control
Design
Two arm parallel-group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Information will be provided for the entry of people with inclusion and exclusion criteria by installing announcements in medical and health centers under the supervision of Shahid Beheshti University of Medical Sciences.Then, the individuals will be divided into two groups of 37 by random block method (blocks with a volume of at least 4 to prevent the blinding of the study to be revealed).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age range 20-60 years
• Do not have any allergies
• Willingness to enter the study
• No supplementation in 6 months before
Exclusion criteria:
• Having any chronic disease
• Having any allergies (whether food or non-food)
• People with digestive problems
Intervention groups
Intervention group: People who will receive collagen, ornithine and probiotic supplements
Control group: People who will receive a maltodextrin supplement
Main outcome variables
Skin health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201226049840N1
Registration date:2021-04-13, 1400/01/24
Registration timing:prospective
Last update:2021-04-13, 1400/01/24
Update count:0
Registration date
2021-04-13, 1400/01/24
Registrant information
Name
Fardin Javanmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
f.javanmardy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation of ِDietary Supplement Using Collagen, Ornithine and Probiotic and its Evaluation on Skin Health Factors in Healthy People: A Double-Blind Randomized Controlled Trial
Public title
Designing a Dietary Supplement to Promote Skin Health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20-60 years
Lack of any allergies
Desire to include the study
Do not take supplements at 6 months ago
Exclusion criteria:
Suffering from any chronic disease
Having any allergies (food or non-food)
People with digestive problems
Age
From 20 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization: Individuals will be assigned to intervention and placebo groups using cards marked 'A' or 'B'. Codes A and B will be written in 70 numbers. So there will be 35 cards A and 35 cards B. After visiting each volunteer, one of these cards will be randomly selected, which will be indicated on the volunteer number card and its group type.
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the people involved in the study, nor any of the interveners, will be aware of the type of intervention being performed on the individuals.The placebo will be completely similar to the formulated powder in terms of appearance, texture and taste, because the same essential oil and color will be used in the placebo and the optimized formula.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Institute of Nutritional Research and Food Industry
Street address
Qods Town( the West ), Shahid Farahzadi Blvd, Shahid Hafezi St
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.SBMU.nnftri.Rec.1400.001
Health conditions studied
1
Description of health condition studied
Healthy subjects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin PH
Timepoint
Before and after 60 days intervention
Method of measurement
PH meter
2
Description
Elasticity
Timepoint
Before and after 60 days of the intervention
Method of measurement
Cotometer
3
Description
Skin moisture
Timepoint
Before and after 60 days of the intervention
Method of measurement
Cornimeter
4
Description
Trans-epidermal water loss
Timepoint
Before and after 60 days of intervention
Method of measurement
Tonometer
5
Description
Skin pigments
Timepoint
Before and after 60 days of the intervention
Method of measurement
Mexameter
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before and after 60 days of intervention
Method of measurement
Scale and meter
Intervention groups
1
Description
Intervention group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet containing collagen, ornithine and probiotic compounds in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again.
Category
Prevention
2
Description
Control group: In this group, on the first day, skin health indicators such as moisture, pH, elasticity, pigment and water loss through the epidermis will be measured. Then, the participants will be trained which dissolve 1 sachet of maltodextrin compounds (22 g) in 200 ml of milk or water daily and eat it as a snack. One sachet will be consumed daily for 60 days during the intervention. Then, at the end of the study, the mentioned skin health indicators will be measured again.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Dolat Dermatology Clinic
Full name of responsible person
Dr. Alireza Firooz
Street address
Daman Afshar Street, Valiasr Avenue, TEHRAN
City
Tehran
Province
Tehran
Postal code
65183 -19697
Phone
+98 21 8888 4196
Email
info@iranderm.net
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Amir Mohammad Mortazavian
Street address
Qods Town( the West ), Shahid Farahzadi Blvd., Shahid Hafezi St.( Western Purple )
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
info@nnftri.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Fardin Javanmardi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Food Technology and Quality Control
Street address
Qods Town( the West ), Shahid Farahzadi Blvd., Shahid Hafezi St
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 6688 0696
Email
f.javanmardy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fardin Javanmardi
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Food Technology and Quality Control
Street address
National Nutrition and Food Technology Research Institute (NNFTRI), West Arghavan St. Farahzadi Blvd., Sharake Qods, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
f.javanmardy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fardin Javanmardi
Position
Ph.D student
Latest degree
Ph.D.
Other areas of specialty/work
Food Technology and Quality Control
Street address
National Nutrition and Food Technology Research Institute (NNFTRI), West Arghavan St. Farahzadi Blvd., Sharake Qods, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Fax
Email
f.javanmardy@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be provided to researchers after analysis and summarization
When the data will become available and for how long
Starting access to results after publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
There are no restrictions on the use of data
From where data/document is obtainable
They should contact with email address: f.javanmardy@gmail.com
What processes are involved for a request to access data/document