Oral Supplementation With Active Collagen Peptides and Skin Health Improvement

NCT06321770 | Completed

• 1 other identifier: 075-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Wrinkles; Skin Hydration

Keywords

low molecular weight collagen peptides; aging; skin health; wrinkles; moisturization; elasticity; nutraceutical; randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• Skin wrinkling volume (px^3)

  Measurement of skin wrinkling volume (px\^3) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)

  6 weeks

• Skin wrinkling area (px^2)

  Measurement of skin wrinkling area (px\^2) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)

  6 weeks

• Skin wrinkling depth (px)

  Measurement of skin wrinkling depth (px) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera)

  6 weeks

• R0= Skin firmness (mm)

  R0 was used as a measure of skin firmness (mm), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties

  6 weeks

• R2= gross elasticity (%) of the skin

  R2 was used as measure of skin gross elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties

  6 weeks

• R5= Skin net elasticity (%)

  R5 was used as measure of skin net elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties

  6 weeks

• R7= Skin elastic recovery (%)

  R7 was used as a measure of skin elastic recovery (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties

  6 weeks

• R9= Skin fatigue (mm)

  R9 was used as a measure of skin fatigue (mm), assessed at the crow's feet region, so a Cutometer® dual MPA 580 (Courage \& Khazaka) was used to assess skin biomechanical properties

  6 weeks

• Skin hydration (AU)

  Measurement of skin hydration (AU) of the stratum corneum was performed at each study visit by the electrical capacitance method using a Corneometer® CM 825 (Courage \& Khazaka, Cologne, Germany).

  6 weeks

Secondary Outcomes (3)

• Subjective perception of product efficacy

  At (T6), six weeks after the trial began

• Subjective perception of the organoleptic characteristics of the product

  At (T6), six weeks after the trial began

• Opinion on the degree of satisfaction with the product

  At (T6), six weeks after the trial began

Study Arms (2)

Bioactive collagen peptide

EXPERIMENTAL

The active treatment group included 40 women who received the bioactive collagen peptide-based food supplement orally

Dietary Supplement: Bioactive collagen peptides

Placebo

PLACEBO COMPARATOR

Oral suspension and sealed in sachets that were identical in appearance and odor. ingredients, which were also contained in the placebo, were 467 mg lemon flavour, 150 mg citric acid, 8.5 mg sucralose and 7.1 mg stevia (97%). The placebo did not contain any nutrients.

Dietary Supplement: Placebo

Interventions

Bioactive collagen peptides DIETARY_SUPPLEMENT

2,5 g collagen peptides

Bioactive collagen peptide

Placebo DIETARY_SUPPLEMENT

Placebo sachet daily

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Women aged 30 to 60 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women (aged 30-65 years) with phototypes I-IV, who were mentally and physically healthy, had a BMI 20.0-29.9 kg/m2 and displayed visible signs of natural and photoaging on their face (crow´s feet) rated from moderate to severe

You may not qualify if:

• Pregnancy, lactation, acute or chronic skin disease 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 unavoidable exposure to UV radiation; tattoos on or near the test area; use of systemic corticosteroids 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 and/or unable to give informed consent; or had any other condition which in the medical investigator\'s opinion may adversely affect the individual\'s ability to complete the study or its measures or which may pose significant risk to the individual.

Sponsors & Collaborators

• Gala Servicios Clinicos S.L.: lead

Study Sites (1)

GALA Laboratories

Don Benito, Badajoz, 06400, Spain

Location

Related Publications (11)

• Tobin DJ. Introduction to skin aging. J Tissue Viability. 2017 Feb;26(1):37-46. doi: 10.1016/j.jtv.2016.03.002. Epub 2016 Mar 14.

  PMID: 27020864 BACKGROUND

• de Miranda RB, Weimer P, Rossi RC. Effects of hydrolyzed collagen supplementation on skin aging: a systematic review and meta-analysis. Int J Dermatol. 2021 Dec;60(12):1449-1461. doi: 10.1111/ijd.15518. Epub 2021 Mar 20.

  PMID: 33742704 BACKGROUND

• Wang H. A Review of the Effects of Collagen Treatment in Clinical Studies. Polymers (Basel). 2021 Nov 9;13(22):3868. doi: 10.3390/polym13223868.

  PMID: 34833168 BACKGROUND

• Shenoy M, Abdul NS, Qamar Z, Bahri BMA, Al Ghalayini KZK, Kakti A. Collagen Structure, Synthesis, and Its Applications: A Systematic Review. Cureus. 2022 May 9;14(5):e24856. doi: 10.7759/cureus.24856. eCollection 2022 May.

  PMID: 35702467 BACKGROUND

• Lupu MA, Gradisteanu Pircalabioru G, Chifiriuc MC, Albulescu R, Tanase C. Beneficial effects of food supplements based on hydrolyzed collagen for skin care (Review). Exp Ther Med. 2020 Jul;20(1):12-17. doi: 10.3892/etm.2019.8342. Epub 2019 Dec 17.

  PMID: 32508986 BACKGROUND

• Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x.

  PMID: 19159383 BACKGROUND

• Pu SY, Huang YL, Pu CM, Kang YN, Hoang KD, Chen KH, Chen C. Effects of Oral Collagen for Skin Anti-Aging: A Systematic Review and Meta-Analysis. Nutrients. 2023 Apr 26;15(9):2080. doi: 10.3390/nu15092080.

  PMID: 37432180 BACKGROUND

• Bolke L, Schlippe G, Gerss J, Voss W. A Collagen Supplement Improves Skin Hydration, Elasticity, Roughness, and Density: Results of a Randomized, Placebo-Controlled, Blind Study. Nutrients. 2019 Oct 17;11(10):2494. doi: 10.3390/nu11102494.

  PMID: 31627309 BACKGROUND

• Choi FD, Sung CT, Juhasz ML, Mesinkovsk NA. Oral Collagen Supplementation: A Systematic Review of Dermatological Applications. J Drugs Dermatol. 2019 Jan 1;18(1):9-16.

  PMID: 30681787 BACKGROUND

• Asserin J, Lati E, Shioya T, Prawitt J. The effect of oral collagen peptide supplementation on skin moisture and the dermal collagen network: evidence from an ex vivo model and randomized, placebo-controlled clinical trials. J Cosmet Dermatol. 2015 Dec;14(4):291-301. doi: 10.1111/jocd.12174. Epub 2015 Sep 12.

  PMID: 26362110 BACKGROUND

• Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.

  PMID: 23949208 BACKGROUND

Study Officials

• Juan Antonio Carrillo

  University of Extremadura

  PRINCIPAL INVESTIGATOR

• Rafael Guerrero

  University of Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, Double-Blind, Placebo-Controlled Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Study

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 20, 2024
• Study Start: March 1, 2024
• Primary Completion: April 16, 2024
• Study Completion: June 3, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)