Impact of Oral Supplementation of Specific Bioactive Collagen Peptides on Human Skin Physiology: A Randomized, Double-Blind, Placebo-Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Collagen Research Institute
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- stratum corneum hydration (SCH)
Overview
Brief Summary
The goal of this clinical trial is to evaluate whether daily oral supplementation with 2.5 g of specific bioactive collagen peptides (SCP) can improve skin physiology in healthy adult women aged 35-55 years. The main questions it aims to answer are:
Does SCP supplementation increase skin hydration and barrier function? Does SCP improve skin elasticity, firmness, and collagen content? Does SCP reduce the appearance of periorbital wrinkles and improve overall skin appearance? Researchers will compare SCP supplementation to a placebo (a look-alike substance containing no collagen peptides) to see if SCP supports skin structure and appearance over eight weeks.
Participants will:
Consume one sachet of SCP or placebo daily for eight weeks Attend three study visits at baseline, week 4, and week 8 for facial imaging, instrumental skin measurements, and expert assessments Have objective measures taken, including skin hydration, transepidermal water loss, elasticity, firmness, dermal collagen content, and 3D wrinkle morphology Complete subjective skin assessments rated by trained evaluators using a visual analogue scale Report any adverse events or intolerance reactions at each visit This study is designed to provide an integrated evaluation of multiple skin parameters, including barrier function, biomechanical properties, dermal matrix composition, and wrinkle characteristics, in a single trial. By combining objective and subjective measures, the study aims to generate robust and clinically interpretable evidence for the effects of oral collagen peptide supplementation on skin health.
Detailed Description
This clinical trial investigates whether daily oral supplementation with specific bioactive collagen peptides (SCP) can support healthy skin in adult women. Skin aging is a natural process influenced by genetics, hormones, and lifestyle, leading to wrinkles, reduced elasticity, and changes in skin structure. Collagen is a key protein that helps maintain skin strength and elasticity, and its levels decline with age.
The study will evaluate the effects of an 8-week course of SCP supplementation compared to a placebo in healthy women aged 35-55 years. Researchers aim to determine whether oral collagen peptides can improve skin hydration, elasticity, firmness, and overall appearance. This trial combines multiple objective and subjective measures to provide a comprehensive assessment of skin health, offering insights into non-invasive nutritional strategies to maintain skin structure and appearance over time.
The findings from this study are expected to enhance understanding of how collagen peptides affect skin physiology and contribute to evidence-based recommendations for supporting healthy skin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Fitzpatrick skin type III-IV
- •Presence of crow's feet wrinkles graded 2-4
- •Presence of under-eye fine lines graded 2-5
- •Generally in good health
- •Able to comply with study procedures and visit schedule
Exclusion Criteria
- •Use of systemic or topical anti-inflammatory medication, including corticosteroids, within the 4 weeks prior to baseline
- •Known hypersensitivity or allergy to any ingredient of the investigational products
- •Pregnancy, breastfeeding, or intention to become pregnant during the study period
- •History of relevant dermatological conditions: psoriasis, eczema, atopic dermatitis, or severe acne
- •Presence of birthmarks, hyperpigmentation, active inflammation, or other visible skin abnormalities in the test areas
- •Recent aesthetic procedures Use of anti-aging or topical treatments
- •Intake of nutritional supplements
- •Participation in other clinical studies within the past 2 months
- •Significant lifestyle or dietary changes during the study period
- •Excessive UV exposure
Arms & Interventions
Specific Collagen Peptides
Participants in this arm receive 2.5 g of specific bioactive collagen peptides (VERISOL®) once daily for 8 weeks. The powder is dissolved in warm water and consumed orally. The supplement contains defined collagen peptides derived from bovine type I collagen, which have been shown to support skin hydration, elasticity, firmness, dermal collagen content, and wrinkle reduction. Participants continue their usual lifestyle habits while taking the supplement.
Intervention: Specific Collagen Peptides (Dietary Supplement)
Maltodextrin
Participants in this arm receive a matching placebo sachet once daily for 8 weeks. The placebo contains plant-derived maltodextrin and is identical in appearance, taste, and texture to the collagen peptide supplement. It is dissolved in warm water and consumed orally. Participants continue their usual lifestyle habits while taking the placebo.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
stratum corneum hydration (SCH)
Time Frame: From enrollment to the end of treatment at 8 weeks
Stratum corneum hydration (SCH) measures the water content in the outermost layer of the skin, reflecting the skin's ability to retain moisture and maintain a healthy barrier. In this study, SCH is the primary efficacy endpoint, used to compare the effect of daily oral supplementation with specific bioactive collagen peptides (SCP) versus placebo over an 8-week period. SCH is assessed using a Corneometer CM825 at the cheek. Each site is measured six times, and the mean value is used for analysis. Higher SCH values indicate better skin hydration, whereas lower values suggest dryness or impaired barrier function. Changes in SCH over time are compared between the treatment and placebo groups to evaluate the impact of collagen peptide supplementation on skin hydration.
Secondary Outcomes
- Transepidermal Water Loss (TEWL)(From enrollment to the end of treatment at 8 weeks)
- Skin Elasticity (R2 and R5) and Firmness (F4)(From enrollment to the end of treatment at 8 weeks)
- Dermal collagen content(From enrollment to the end of treatment at 8 weeks)
- Wrinkle Morphology(From enrollment to the end of treatment at 8 weeks)
- Skin Appearance (3D Imaging + VAS)(From enrollment to the end of treatment at 8 weeks)