IMPACT OF SUPPLEMENTATION WITH LOW MOLECULAR WEIGHT HYDROLYZED COLLAGEN AND VERISOL ON THE EXPRESSION OF LINES, SKIN QUALITY, AND LEVELS OF KLOTHO, VEGF, AND TGF-BETA IN THE EYE REGION

NCT ID: NCT06971029

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-09

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Health Collagen Supplementation Growth Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Verisol Collagen 2.5 g/day

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.

Group Type EXPERIMENTAL

Supplementation with Verisol®

Intervention Type DIETARY_SUPPLEMENT

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.

Peptech Collagen 2.5 g/day (GCP 2.5)

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.

Group Type EXPERIMENTAL

Supplementation with Peptech® 2.5G

Intervention Type DIETARY_SUPPLEMENT

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.

eptech Collagen 10 g/day (GCP 10)

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.

Group Type EXPERIMENTAL

Supplementation with Peptech® 10.0G

Intervention Type DIETARY_SUPPLEMENT

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.

Group Control

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

Group Type OTHER

Control group

Intervention Type DIAGNOSTIC_TEST

The control group will not receive supplementation.

Interventions

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Supplementation with Verisol®

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.

Intervention Type DIETARY_SUPPLEMENT

Supplementation with Peptech® 2.5G

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.

Intervention Type DIETARY_SUPPLEMENT

Supplementation with Peptech® 10.0G

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.

Intervention Type DIETARY_SUPPLEMENT

Control group

The control group will not receive supplementation.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

* "Inclusion criteria require that volunteers be between 35 and 58 years old, have been sedentary for at least one year, and, after reading and understanding all stages of the study, agree to and sign the informed consent form (ICF).

Exclusion Criteria:

* "Exclusion criteria include undergoing facial aesthetic procedures involving hyaluronic acid or botulinum toxin, being an active or passive smoker within the past 3 years, using protein- or amino acid-based supplements within the past 6 months, or using cosmetics with skin-repairing properties in the orbicularis oculi region.
Minimum Eligible Age

35 Years

Maximum Eligible Age

58 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rodolfo de Paula Vieira

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

(62)3310-6736

References

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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.

Reference Type RESULT
PMID: 19043850 (View on PubMed)

Other Identifiers

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7.233.377

Identifier Type: -

Identifier Source: org_study_id

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