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临床试验/NCT07521423
NCT07521423已完成不适用

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

Marianna Kapetanou1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
92
试验地点
1
主要终点
Change in plasma Pro-Collagen I Alpha levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
29 Years 至 82 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Collagen-Supporting Nutraceutical Formulation (Dietary Supplement)

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.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change in plasma Pro-Collagen I Alpha levels

时间窗: Baseline (Day 0) and Week 6

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

Change in plasma protein carbonyl levels

时间窗: Baseline (Day 0) and Week 6

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

Change in plasma Advanced Glycation End Products (AGEs) levels

时间窗: Baseline (Day 0) and Week 6

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

次要结局

  • Participant-reported self-assessment of skin-related effects and tolerability(Week 6)

研究者

发起方
Marianna Kapetanou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marianna Kapetanou

Principal Investigator

Hellenic Pasteur Institute

研究点 (1)

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