Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321770
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2024-03-09
Brief Title:
Oral Supplementation With Active Collagen Peptides and Skin Health Improvement
Sponsor:
Gala Servicios Clinicos SL
Organization:
Gala Servicios Clinicos SL
Study Overview
Official Title:
Oral Supplementation With Low Molecular Weight Collagen Peptides Improves Facial Wrinkles and Skin Hydration Results From a Six-Week Randomized Double-Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study aims to investigate the efficacy of daily supplementation with COLLinstant LMW over a 6-week period in improving visible signs of aging This in-cludes assessing its impact on skin wrinkle reduction as well as its potential to en-hance skin elasticity and moisturization COLLinstant LMW was administered orally in a single-center randomized double-blind placebo-controlled clinical trial A sec-ondary objective involves comparing skin improvement product satisfaction and monitoring adverse events among middle-aged female volunteers
Detailed Description:
Study design and ethical aspects This was a 6-week prospective randomized placebo-controlled double-blind monocentric study performed at GALA Laboratories in Don Benito-Villanueva Badajoz Spain
Participants were individually randomized 11 ratio to a strategy of receiving either COLLinstant LMW collagen group or a placebo regimen and followed up for 6 weeks Subjects were instructed to dose both product regimens as per the manufacturers package instructions or when appropriate investigator guidance
The investigation was performed according to the ethical guidelines detailed in the Declaration of Helsinki amendment of the 64th General Assembly Fortaleza Brazil October 2013 and with national regulations of Spain and in full compliance with the applicable principles of good clinical practice GCP and International Council for Harmonisation ICH of Technical Requirements for Pharmaceuticals for Human Use The trial protocol was approved code 075-2022 by the Clinical Research Ethics Committee at the University Hospital of Cáceres Caceres Spain and written informed consent was obtained from all subjects prior to any study procedures being ini-tiated
Interventionstudy products The test product is classified as a food supplement The preparation under study was COLLinstant LMW Viscofan DE GmbH Weinheim Germany an oral food supplement based on bovine bioactive hydrolyzed type I and III-collagen peptides
Following ICH-GCP requirements and applicable local regulations the inves-tigational product and placebo were presented as a powder for oral suspension and sealed in sachets that were identical in appearance and odor
Each sachet of the active COLLinstant LMW contained low molecular weight hydrolyzed 25 g collagen peptides Other ingredients which were also contained in the placebo were 467 mg lemon flavour 150 mg citric acid 85 mg sucralose and 71 mg stevia 97 The placebo did not contain any nutrients
Study subjects We recruited a total of 80 women aged 30-65 years with phototypes I-IV who were mentally and physically healthy had a BMI 200-299 kgm2 and displayed visible signs of natural and photoaging on their face crows feet rated from moderate to se-vere 21
The Fitzpatrick scale is a numerical classification for human skin color in a scale of I-VI with the amount of melanin in the skin indicating the type of skin its suscep-tibility to burns and its ability to tan
During the screening phase the participants satisfied all inclusion and exclusion criteria and agreed to avoid prolonged exposure to ultraviolet UV radiation for the duration of the study
Subjects were excluded in case of pregnancy lactation acute or chronic skin dis-ease or dermatological disorder use of natural health supplements for improving the skin within 1 month before the start of the study low protein diet planned or una-voidable exposure to UV radiation tattoos on or near the test area use of systemic cor-ticosteroids or applied topical alpha hydroxyl acids near the test site within 4 weeks of enrolment use of topical medications near the test area within 6 weeks of enrolment Botulinum toxin A Botox treatment or filler injection collagen hyaluronic acid etc near the test sites within 2 years of enrolment subjects cognitively impaired andor unable to give informed consent or had any other condition which in the medical in-vestigators opinion may adversely affect the individuals ability to complete the study or its measures or which may pose significant risk to the individual
Study schedule and biometric evaluation All participants test and placebo group were instructed to consume the content of one sachet daily in the morning on an empty stomach for 6 weeks It was required that the product was dissolved in at least 100 ml of water juice or other liquid
For all women participating in the study biometric characteristics were assessed at baseline T0 and after 6 weeks of treatment with the products T6
Measurement of skin wrinkling parameters volume area and depth was evalu-ated at the crows feet region and changes were analyzed and digitally photographed in all patients by VisioFace 1000D equipped with a high-resolution reflex camera
Afterwards subjects were acclimatized for at least 30 min in the air-conditioned measurement room at a temperature of 21 1C and a relative humidity of 50 5
Skin elasticity was measured at the crows feet region so a Cutometer dual MPA 580 Courage Khazaka was used to assess skin biomechanical properties This non-invasive tool evaluated the skin elasticity by negative force that distorts the skin mechanically The functional principle is based on suction of the skin using a probe with negative pressure 450 mbar which causes the test area to be drawn into the ap-erture of the probe A non-contact optical measuring system determined the penetra-tion depth of the skin The parameters evaluated were R0 R2 R5 R7 y R9 and measurements were carried out in triplicate
R0 represents the final distension of the first curve ie the passive behavior of the skin to the suction force and correlates to the skin firmness This parameter is meas-ured from the highest point of amplitude at the end of the suction phase to the baseline reading R0 Uf
The R2 parameter is related to the gross elasticity viscoelasticity which is the skins resistance to the mechanical suction force versus its ability to recover R2 UaUf
R5 refers to net elasticity and is represented by the ratio of the elastic portion of the suction stage to fast recovery throughout relaxation stage R5 UrUe meaning the higher the value the more elastic the skin R7 is related to biological elasticity R7 is the immediate elastic recovery in the first 01 s compared with the amplitude total deformation after suction R7 UrUf and can be interpreted as another marker of elasticity with aging causing its reduction and R9 the residual deformation at the end of the measuring cycle indicating the tiring effects or fatigue of skin after repeated suction R9 R3 - R0
In addition measurement of stratum corneum hydration was performed at each study visit by the electrical capacitance method using a Corneometer CM 825 Courage Khazaka Cologne Germany At least five determinations per measure-ment area at four different locations middle forehead both right and left cheek bone and the chin area were performed then the average was used for analysis
Self-reported measures After 6 weeks of treatment the volunteers filled out questionnaires to subjectively assess their perception of different parameters such as efficacy organoleptic properties and satisfaction since the last time they took the product The Spanish version of the Treatment Satisfaction Questionnaire with Medication TSQM and a 3-point Likert scale with the following items Dissatisfied slightly satisfied and very satisfied were used
Participants were individually randomized 11 ratio to a strategy of receiving either COLLinstant LMW collagen group or a placebo regimen and followed up for 6 weeks Subjects were instructed to dose both product regimens as per the manufacturers package instructions or when appropriate investigator guidance
The investigation was performed according to the ethical guidelines detailed in the Declaration of Helsinki amendment of the 64th General Assembly Fortaleza Brazil October 2013 and with national regulations of Spain and in full compliance with the applicable principles of good clinical practice GCP and International Council for Harmonisation ICH of Technical Requirements for Pharmaceuticals for Human Use The trial protocol was approved code 075-2022 by the Clinical Research Ethics Committee at the University Hospital of Cáceres Caceres Spain and written informed consent was obtained from all subjects prior to any study procedures being ini-tiated
Interventionstudy products The test product is classified as a food supplement The preparation under study was COLLinstant LMW Viscofan DE GmbH Weinheim Germany an oral food supplement based on bovine bioactive hydrolyzed type I and III-collagen peptides
Following ICH-GCP requirements and applicable local regulations the inves-tigational product and placebo were presented as a powder for oral suspension and sealed in sachets that were identical in appearance and odor
Each sachet of the active COLLinstant LMW contained low molecular weight hydrolyzed 25 g collagen peptides Other ingredients which were also contained in the placebo were 467 mg lemon flavour 150 mg citric acid 85 mg sucralose and 71 mg stevia 97 The placebo did not contain any nutrients
Study subjects We recruited a total of 80 women aged 30-65 years with phototypes I-IV who were mentally and physically healthy had a BMI 200-299 kgm2 and displayed visible signs of natural and photoaging on their face crows feet rated from moderate to se-vere 21
The Fitzpatrick scale is a numerical classification for human skin color in a scale of I-VI with the amount of melanin in the skin indicating the type of skin its suscep-tibility to burns and its ability to tan
During the screening phase the participants satisfied all inclusion and exclusion criteria and agreed to avoid prolonged exposure to ultraviolet UV radiation for the duration of the study
Subjects were excluded in case of pregnancy lactation acute or chronic skin dis-ease or dermatological disorder use of natural health supplements for improving the skin within 1 month before the start of the study low protein diet planned or una-voidable exposure to UV radiation tattoos on or near the test area use of systemic cor-ticosteroids or applied topical alpha hydroxyl acids near the test site within 4 weeks of enrolment use of topical medications near the test area within 6 weeks of enrolment Botulinum toxin A Botox treatment or filler injection collagen hyaluronic acid etc near the test sites within 2 years of enrolment subjects cognitively impaired andor unable to give informed consent or had any other condition which in the medical in-vestigators opinion may adversely affect the individuals ability to complete the study or its measures or which may pose significant risk to the individual
Study schedule and biometric evaluation All participants test and placebo group were instructed to consume the content of one sachet daily in the morning on an empty stomach for 6 weeks It was required that the product was dissolved in at least 100 ml of water juice or other liquid
For all women participating in the study biometric characteristics were assessed at baseline T0 and after 6 weeks of treatment with the products T6
Measurement of skin wrinkling parameters volume area and depth was evalu-ated at the crows feet region and changes were analyzed and digitally photographed in all patients by VisioFace 1000D equipped with a high-resolution reflex camera
Afterwards subjects were acclimatized for at least 30 min in the air-conditioned measurement room at a temperature of 21 1C and a relative humidity of 50 5
Skin elasticity was measured at the crows feet region so a Cutometer dual MPA 580 Courage Khazaka was used to assess skin biomechanical properties This non-invasive tool evaluated the skin elasticity by negative force that distorts the skin mechanically The functional principle is based on suction of the skin using a probe with negative pressure 450 mbar which causes the test area to be drawn into the ap-erture of the probe A non-contact optical measuring system determined the penetra-tion depth of the skin The parameters evaluated were R0 R2 R5 R7 y R9 and measurements were carried out in triplicate
R0 represents the final distension of the first curve ie the passive behavior of the skin to the suction force and correlates to the skin firmness This parameter is meas-ured from the highest point of amplitude at the end of the suction phase to the baseline reading R0 Uf
The R2 parameter is related to the gross elasticity viscoelasticity which is the skins resistance to the mechanical suction force versus its ability to recover R2 UaUf
R5 refers to net elasticity and is represented by the ratio of the elastic portion of the suction stage to fast recovery throughout relaxation stage R5 UrUe meaning the higher the value the more elastic the skin R7 is related to biological elasticity R7 is the immediate elastic recovery in the first 01 s compared with the amplitude total deformation after suction R7 UrUf and can be interpreted as another marker of elasticity with aging causing its reduction and R9 the residual deformation at the end of the measuring cycle indicating the tiring effects or fatigue of skin after repeated suction R9 R3 - R0
In addition measurement of stratum corneum hydration was performed at each study visit by the electrical capacitance method using a Corneometer CM 825 Courage Khazaka Cologne Germany At least five determinations per measure-ment area at four different locations middle forehead both right and left cheek bone and the chin area were performed then the average was used for analysis
Self-reported measures After 6 weeks of treatment the volunteers filled out questionnaires to subjectively assess their perception of different parameters such as efficacy organoleptic properties and satisfaction since the last time they took the product The Spanish version of the Treatment Satisfaction Questionnaire with Medication TSQM and a 3-point Likert scale with the following items Dissatisfied slightly satisfied and very satisfied were used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None