Effects of a Dietary Supplement on Collagen Production and Evaluation of Its Regenerative and Anti-Ageing Propertiess

NCT07521423 | Completed

• 1 other identifier: 3 8 1 3 / 1 7 - 0 6 - 2 0 2 4
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of a dietary supplement containing natural bioactive compounds on biological processes associated with skin ageing and extracellular matrix integrity. Ageing is characterized by a progressive decline in the function of dermal fibroblasts, the primary cells responsible for collagen production and maintenance of skin structure. Over time, these cells exhibit reduced proliferative capacity, decreased collagen synthesis, and increased accumulation of oxidative and glycative damage, leading to deterioration of skin elasticity and overall tissue homeostasis. The study integrates in vitro and clinical approaches to investigate the potential benefits of the formulation. In the clinical component, healthy adult participants received either the nutraceutical formulation or a matched placebo daily for a period of six weeks. Blood samples were collected at baseline and at the end of the intervention to assess changes in systemic biomarkers associated with collagen metabolism, oxidative stress, and glycation. Specifically, the study measured circulating levels of Pro-Collagen I Alpha as an indicator of collagen biosynthesis, protein carbonyls as markers of oxidative protein damage, and Advanced Glycation End Products as markers of glycation-related molecular damage. These biomarkers collectively reflect key biological mechanisms underlying skin ageing and broader ageing processes. The objective of the study is to determine whether supplementation with the formulation can support extracellular matrix homeostasis, enhance collagen production, and reduce molecular damage associated with oxidative stress and glycation, thereby contributing to healthy ageing.

Conditions

Healthy Ageing; Skin Ageing; Oxidative Stress

Keywords

Healthy Ageing; Skin Ageing; Collagen Biosynthesis; Extracellular Matrix; Oxidative Stress; Protein Carbonyls; Advanced Glycation End Products; Proteostasis; Nutraceutical; Dietary Supplement; Antioxidants; Collagen Metabolism

Outcome Measures

Primary Outcomes (3)

• Change in plasma Pro-Collagen I Alpha levels

  Change in circulating Pro-Collagen I Alpha concentrations as a biomarker of collagen biosynthesis and extracellular matrix turnover.

  Baseline (Day 0) and Week 6

• Change in plasma protein carbonyl levels

  Change in plasma protein carbonyl concentrations as a measure of oxidative protein damage.

  Baseline (Day 0) and Week 6

• Change in plasma Advanced Glycation End Products (AGEs) levels

  Change in plasma AGEs concentrations as a measure of glycation-related molecular damage.

  Baseline (Day 0) and Week 6

Secondary Outcomes (1)

• Participant-reported self-assessment of skin-related effects and tolerability

  Week 6

Study Arms (2)

Nutraceutical Formulation

EXPERIMENTAL

Participants receive an oral nutraceutical formulation containing collagen peptides, amino acids, antioxidants, vitamins, and trace elements designed to support collagen biosynthesis, extracellular matrix homeostasis, and reduction of oxidative and glycative stress. The formulation is administered daily for six weeks.

Dietary Supplement: Collagen-Supporting Nutraceutical Formulation

Placebo Comparator

PLACEBO COMPARATOR

Participants receive a matched placebo formulation administered orally on a daily basis for six weeks. The placebo is similar in appearance and dosing schedule to the active intervention but does not contain bioactive ingredients.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

The placebo consists of an inert oral formulation matched in appearance and administration schedule to the active dietary supplement. It contains excipients without active bioactive ingredients and is administered daily for six weeks.

Placebo Comparator

Collagen-Supporting Nutraceutical Formulation DIETARY_SUPPLEMENT

The intervention consists of an oral dietary supplement formulated to support collagen biosynthesis and extracellular matrix homeostasis. Each tablet contains hydrolyzed marine collagen peptides, hyaluronic acid, and amino acids (glycine, proline, hydroxyproline) involved in collagen formation and stabilization. The formulation also includes antioxidant compounds (quercetin, reduced glutathione, astaxanthin) to support redox balance, as well as vitamin C and zinc as cofactors in collagen synthesis. Additional components include vitamin D3 and biotin to support cellular and skin health. The supplement is administered daily for six weeks.

Nutraceutical Formulation

Eligibility Criteria

• Age: 29 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 29 to 82 years Individuals with Fitzpatrick skin types I-VI Presence of mild to moderate fine lines and wrinkles Presence of mild to moderate photoaging consistent with chronological ageing Generally healthy individuals without known medical conditions that, in the opinion of the investigator, could interfere with study participation Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• \. Body mass index (BMI) greater than 28 kg/m² Current diagnosis of cancer and/or undergoing chemotherapy or radiotherapy Use of dietary supplements during the study period Ongoing long-term treatment for autoimmune or chronic diseases Pregnancy, breastfeeding, or intention to become pregnant during the study period Severe photoaging beyond mild to moderate classification History of cosmetic procedures or dermatological conditions that, in the opinion of the investigator, could interfere with accurate skin assessment, including but not limited to rosacea, acne, or excessively oily or dry skin Known hypersensitivity or allergic reaction to any component of the study product

Sponsors & Collaborators

• Marianna Kapetanou: lead

Study Sites (1)

Hellenic Pasteur Institute

Athens, Attica, 11521, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)