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AzTrials

Healthy AgeingREGEN-CNCT07521423

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

A study testing Collagen-Supporting Nutraceutical Formulation in people with Healthy Ageing and Skin Ageing, run by Marianna Kapetanou at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 29 to 82 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Ageing, Skin Ageing, Oxidative Stress
What is being tested?
Collagen-Supporting Nutraceutical Formulation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteGreece
Study dates
1 Oct 2025to 1 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 29 to 82 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 1. 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

Trial locations and contacts

1 site in 1 country.

Greece1 site
  • Hellenic Pasteur Institute

    Athens, Attica, 11521

Other trials in Greece

About this study

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.

Read more

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.

Read the detailed description

Ageing of the skin is a multifactorial biological process characterized by progressive structural and functional decline of the dermis. Dermal fibroblasts are the principal cells responsible for the synthesis and maintenance of the extracellular matrix (ECM), including type I and type III collagen, which are essential for maintaining skin integrity, elasticity, and mechanical strength. During ageing, fibroblasts progressively lose proliferative capacity and enter a state of replicative senescence associated with irreversible cell-cycle arrest and altered cellular function. This transition is driven by mechanisms such as telomere shortening, oxidative stress, mitochondrial dysfunction, and persistent DNA damage responses, ultimately leading to reduced collagen synthesis and impaired tissue repair.

In parallel, ageing is accompanied by increased oxidative and glycative stress, which contribute to cumulative molecular damage. Oxidative modification of proteins results in the formation of protein carbonyls, widely recognized as stable markers of oxidative protein damage. Glycation reactions lead to the formation of Advanced Glycation End Products (AGEs), which accumulate in long-lived proteins such as collagen, promoting crosslinking, reduced tissue elasticity, and impaired extracellular matrix remodeling. These processes are further amplified by the accumulation of senescent fibroblasts, which secrete pro-inflammatory and matrix-remodeling factors, contributing to chronic low-grade inflammation and progressive tissue deterioration.

Targeting these interconnected mechanisms, including extracellular matrix metabolism, oxidative stress, glycation, and proteostasis, represents a promising strategy for supporting healthy ageing. Nutraceutical formulations containing natural bioactive compounds have emerged as potential modulators of these pathways, with evidence suggesting their ability to enhance antioxidant defenses, reduce protein damage, and support collagen biosynthesis.

The present study applies a translational framework to evaluate the biological effects of a collagen-supporting nutraceutical formulation. The investigation included an initial in vitro component using human fibroblasts to assess cellular responses related to ageing dynamics, followed by a randomized, placebo-controlled clinical intervention in healthy adults to determine systemic effects.

In the clinical study, participants received either the nutraceutical formulation or a matched placebo administered orally for six consecutive weeks. The formulation consisted of a combination of structural components of collagen, amino acids involved in collagen biosynthesis, antioxidants, enzymatic cofactors, and micronutrients supporting skin and cellular homeostasis. Specifically, each tablet contained hydrolyzed marine collagen peptides (200 mg) and hyaluronic acid (100 mg) to support extracellular matrix structure and hydration. It also included key amino acids required for collagen synthesis, namely glycine (120 mg), proline (60 mg), and hydroxyproline (60 mg), which contribute to collagen formation, stabilization, and maturation.

To address oxidative stress and molecular damage, the formulation incorporated antioxidant compounds including quercetin (50 mg), reduced glutathione (50 mg), and astaxanthin (0.1 mg), aiming to enhance cellular redox balance and protect proteins and membranes from oxidative modification. In addition, vitamin C (80 mg) and zinc (10 mg) were included as essential cofactors for enzymatic processes involved in collagen biosynthesis. The formulation was further supplemented with vitamin D3 (30 μg, 1200 IU) and biotin (100 μg) to support cellular homeostasis, skin health, and metabolic regulation. Excipients were included to ensure stability and appropriate tablet formulation.

Blood samples were collected at baseline and at the end of the intervention period to evaluate changes in circulating biomarkers associated with key biological processes relevant to ageing. The selected biomarkers included Pro-Collagen I Alpha as an indicator of collagen biosynthesis and extracellular matrix turnover, protein carbonyls as markers of oxidative protein damage, and Advanced Glycation End Products as markers of glycation burden. Together, these biomarkers provide complementary information on collagen metabolism, oxidative stress, and protein modification, allowing for an integrated assessment of biological ageing processes.

The study is designed to determine whether supplementation with the formulation can modulate these biomarkers in a manner consistent with improved extracellular matrix homeostasis and reduced molecular damage. By focusing on measurable systemic endpoints linked to fundamental mechanisms of ageing, the study aims to provide evidence for the potential role of targeted nutraceutical interventions in supporting skin health and broader healthy ageing trajectories.

Being tested
Collagen-Supporting Nutraceutical Formulation, Placebo
Keywords
Healthy Ageing, Skin Ageing, Collagen Biosynthesis, Extracellular Matrix, Oxidative Stress, Protein Carbonyls, Advanced Glycation End Products, Proteostasis, Nutraceutical, Dietary Supplement, Antioxidants, Collagen Metabolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collagen-Supporting Nutraceutical FormulationDietary 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.

  • PlaceboDietary 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.

Study groups in NCT07521423
Study groupRoleWhat they receive
Nutraceutical FormulationExperimentalParticipants 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.
Receives: Dietary Supplement: Collagen-Supporting Nutraceutical Formulation
Placebo ComparatorPlacebo comparatorParticipants 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.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 0) and Week 6

  2. Change in plasma protein carbonyl levels

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

    Measured: Baseline (Day 0) and Week 6

  3. Change in plasma Advanced Glycation End Products (AGEs) levels

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

    Measured: Baseline (Day 0) and Week 6

Secondary outcomes (1)
  1. Participant-reported self-assessment of skin-related effects and tolerability

    Self-administered participant questionnaire evaluating perceived effects of the intervention on skin appearance and condition, including elasticity, hydration, wrinkle appearance, pigmentation-related changes, and overall skin quality, together with general well-being and any self-reported adverse effects.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start1 Oct 2025
  3. Primary completion1 Feb 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07521423
Sponsor's protocol ID
3 8 1 3 / 1 7 - 0 6 - 2 0 2 4
Acronym
REGEN-C
Status last verified
Mar 2026
First submitted
3 Apr 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) will not be shared due to privacy and data protection considerations, including compliance with applicable regulations such as the General Data Protection Regulation (GDPR). Data will be reported and made available in aggregate form to ensure participant confidentiality.

Questions about this trial

What is this clinical trial studying?

A study testing Collagen-Supporting Nutraceutical Formulation in people with Healthy Ageing and Skin Ageing, run by Marianna Kapetanou at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma Pro-Collagen I Alpha levels (time frame: Baseline (Day 0) and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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