NCT06971029

Brief Summary

Skin is the largest organ of the human body and performs various vital functions, including protection against external agents, regulation of body temperature, and sensory perception. As we age, our skin undergoes a series of changes that can be noticeable both visually and physically. One of the most evident changes is the appearance of wrinkles and fine lines, resulting from decreased skin elasticity and reduced production of collagen and elastin. Nutrition plays a key role in skin health, influencing its structure, function, and ability to defend against damage and diseases. However, it is unknown to what extent supplementation with different types of collagens can attenuate these effects in middle-aged women. Therefore, the present study aims to recruit 150 middle-aged women (35-58 years old) who will be randomized into three groups, Verisol Collagen 2.5 g/day, Peptech Collagen 2.5 g/day, and Peptech Collagen 10 g/day, 7 days a week, for 3 months. Skin hydration, oiliness, and flexibility, as well as the number and depth of expression lines, will be evaluated, along with plasma levels of Klotho, VEGF, and TGF-beta. Data will be analyzed, and graphs constructed using GraphPad Prism 5.0 software (California, USA). The normality distribution of the data will be assessed by the Kolmogorov-Smirnov test. Data with parametric distribution will be subjected to paired Student's t-test for intragroup comparison, and unpaired t-test will be used for comparison between groups. Significance levels will be considered statistically different for p\<0.05.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

June 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 6, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

Skin healthcollagen supplementationgrowth factors

Outcome Measures

Primary Outcomes (1)

  • Plasma levels of Klotho, VEGF, and TGF-beta

    Three months.

Study Arms (4)

Verisol Collagen 2.5 g/day

EXPERIMENTAL

Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Dietary Supplement: Supplementation with Verisol®

Peptech Collagen 2.5 g/day (GCP 2.5)

EXPERIMENTAL

Supplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Dietary Supplement: Supplementation with Peptech® 2.5G

eptech Collagen 10 g/day (GCP 10)

EXPERIMENTAL

Supplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Dietary Supplement: Supplementation with Peptech® 10.0G

Group Control

OTHER

he control group will undergo the tests but will not receive supplementation.

Diagnostic Test: Control group

Interventions

Supplementation with Verisol® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Verisol Collagen 2.5 g/day

Supplementation with Peptech® collagen will be administered at a dose of 2.5 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

Peptech Collagen 2.5 g/day (GCP 2.5)

Supplementation with Peptech® collagen will be administered at a dose of 10.0 g/day, diluted in water or water-based juice (300-500 mL), and should be consumed daily, 7 days a week, for 3 months.

eptech Collagen 10 g/day (GCP 10)
Control groupDIAGNOSTIC_TEST

The control group will not receive supplementation.

Group Control

Eligibility Criteria

Age35 Years - 58 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.

  • Paula-Vieira RHR, Dias SR, Silva-Reis A, Moura-Maia MS, Ramos-Gomes NV, Jesus-Silva K, Oliveira-Leal YR, Castro-Pimentel LT, Carvalho WSF, Melo F, Martins JLR, Bachi ALL, Vieira RP. Immune-Modulatory Effects of Bioactive Collagen Peptides Improve Skin Health in Middle-Aged Women. Dermatol Ther (Heidelb). 2026 Jan 27. doi: 10.1007/s13555-026-01654-9. Online ahead of print.

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Luis Vicente Franco de Oliveira Coordinator of the Stricto Sensu Graduate Program in Human Mov

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The 150 volunteers will be randomized into three groups (n = 50/group): Verisol Collagen 2.5 g/day (GCV), Peptech Collagen 2.5 g/day (GCP 2.5), and Peptech Collagen 10 g/day (GCP 10).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

June 9, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share