Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink for improvement of biophysical and ultrasonography skin parameters
Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink for improvement of biophysical and ultrasonography skin parameters.
Design
It is an interventional study as a randomized double blinded clinical study. 30 healthy adult volunteers will participate enrolled in the study after signing informed consent. Simple randomization is performed to assign each participant, using blind cards. In this way, the name of the formulation is written on the same cards. A card is selected randomly for each person.
Settings and conduct
The study will be conducted in Center for Research & Training in Skin Diseases and Leprosy. Volunteers in two separate groups consume 250ml of collagen-containing and collagen-free drinks daily for two weeks.
The assessments of skin biophysical parameters (skin elasticity, Skin thickness and density and changes in stratum corneum hydration) will be performed before intervention and 4, 8 and 12 weeks after using. Then the changes in each parameter are compared in different groups.
Participant blindness performed packing products in similar containers with different numeric code. For assessor blinding, the randomization list is given to a third person. Formulation to the participants assigned after receiving the randomization code by researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ages 35 to 55, Healthy people with skin type II to V, Signing the consent form for participation in the study.
Exclusion criteria:
History of using RF, anti-aging and intense pulsed light during the past 6 months, Active smoker in last 2 years
Intervention groups
Intervention group: daily consumption of 250 ml of Alis collagen supplement drink for 8 weeks
Control group: daily consumption of 250 ml of a drink without collagen for 8 weeks
Main outcome variables
Changing in skin elasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N22
Registration date:2023-09-20, 1402/06/29
Registration timing:prospective
Last update:2023-09-20, 1402/06/29
Update count:0
Registration date
2023-09-20, 1402/06/29
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink for improvement of biophysical and ultrasonography skin parameters
Public title
Safety and efficacy of assessment of Alis collagen drink (containing 4 g hydrolyzed collagen) compared to a control collagen-free drink
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 35 to 55
Healthy people with skin type II to V
Signing the consent form for participation in the study
Exclusion criteria:
History of using RF, anti aging and intense pulsed light during the past 6 months
.Active smoker in last 2 years
Pregnancy or lactating
Suffering from systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, as well as liver and kidney failure.
History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months
Age
From 35 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by simple randomization using a blind card, In this way, the name of the formulation is written on the same cards. A card is selected randomly for each person.
Blinding (investigator's opinion)
Double blinded
Blinding description
In case of assessor blinding, the randomization list is given to a third person. Assignment of the formulation to participants is made after receiving the code of randomization by researcher. Participant blindness performed packing products in similar containers with different numeric code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The Institute of Pharmaceutical Sciences of Tehran University of Medical Science
Street address
Unit 1-219, 2nd floor, The Institute of Pharmaceutical Sciences, Faculty of Pharmacy, 16 Azar Avenue
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-09-05, 1402/06/14
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.076
Health conditions studied
1
Description of health condition studied
skin aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Skin elasticity
Timepoint
Before intervention , 4, 8 and 12 weeks after using
Method of measurement
Cutometery
Secondary outcomes
1
Description
Skin thickness and density
Timepoint
Before intervention ,4 , 8 and 12 weeks after using
Method of measurement
Skin ultrasound
2
Description
Changes in stratum corneum hydration
Timepoint
Before intervention , 4, 8 and 12 weeks after using
Method of measurement
Corneometry
Intervention groups
1
Description
Intervention group: daily consumption of 250 ml of Alis collagen supplement drink for 8 weeks, which includes: Spring water, hydrolyzed bovine collagen protein (food grade) 4g, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr)
Category
Treatment - Drugs
2
Description
Control group: daily consumption of 250 ml of collagen-free drink for 8 weeks, which includes: Spring water, acerola powder-vitamin A (0.0066 gr/lit), vitamin C (1 gram of acerola powder with 32% purity of vitamin C has been added in the formulation), vitamin E (0.75 gr/lit and hyaluronic acid (0.022gr)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy, Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pishgamane Eixire Sabze Arvand Co.
Full name of responsible person
Nasrin Fayyaz
Street address
No. 108, 3rd Taleghani, Ahmed Abad Street, Mashhad
City
Tehran
Province
Tehran
Postal code
9176755149
Phone
+98 51 3838 7279
Email
info@idcalis.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pishgamane Eixire Sabze Arvand Co.
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Aniseh Samadi
Position
MD and Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Firooz
Position
Dermatologist and professor of Tehran University of Medical Sciences.
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
firozali@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Dermatology
Street address
No. 415, Naderi Aven., Taleghani St.
City
Tehran
Province
Tehran
Postal code
1416613675
Phone
+98 21 8897 2220
Email
dermalab@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available