Effect of a French Maritim Pine Bark Extract Oligopin® on Skin Ageing. Double Blind, Parallel, Randomized, Placebo Controled Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in skin elasticity
研究概览
简要总结
Extrinsic or exogenous ageing is caused by repetitive exposure of the skin to harmful agents, while primary cause the exposure to ultraviolet (UV) radiation, known as photoageing, including solar effect. Chronic solar UV exposure has multiple damaging effects on skin, such as wrinkling, dryness, dyspigmentation, epidermal thinning and increasing fragility. In addition, solar exposure and age increase a subepidermal band.
Fibrillar collagen, which is synthesized from fibroblasts, is the predominant extracellular matrix (ECM) component of the dermis. Collagen type I and III are considered to be the major interstitial, fiber forming collagen in normal human dermis. In addition, the dermis contains collagen types IV (gelatine), V and VI. Other important component of the EMC of the dermis are elastic fibers being elastin (ELN) their main component and play a critical role in skin elasticity and the reduction of elastic fiber production results in impaired elasticity. UV radiation induces ECM degeneration and consequently an increase in fragility and loss of elasticity of the skin. This process is mediated by an increase in matrix metalloproteinases (MMPs) expression in human skin which are responsible for degrading ECM proteins, such as collagen, fibronectin and elastin. The natural inhibitors of MMPs are tissue inhibitors of metalloproteinases (TIMPs), being TIMP-1 the most relevant TIMP affecting collagen metabolism.
详细描述
Orally administered ingredients can have positive effects on skin characteristics by modulating the internal factors leading to the changes associated with photoageing. Thus, the use of food ingredients and supplements that claim to reduce the risk of skin disorders or alleviate skin ageing is increasing.
Between these ingredients, polyphenols obtained from botanical extracts has been used for cosmetic applications, including Pycnogenol®, a French Maritime Pine Bark extract (FMPBE). showing photoprotective effect against UV-light induced skin damages, and an improvement in hydratation and elasticity of skin in human clinical trials. In another clinical trial, treatment with a different FMPBE called Flavangenol®, significantly decreased skin photo-aged scores. Other human intervention studies with oral administration of polyphenol extracts of different origins such as citrus extract (NutroxSun®), red orange fruit extract (Red Orange Complex®), Polypodium leucotomos and Pomegranate extracts (PPmix® and Fernblock®) have demonstrated beneficials effects of these supplements on improvement of skin characteristics.
The results of the studies cited above suggest that oral administration of polyphenols rich extracts and especially of FMPBE is a promising approach for nutritional photoprotection of skin, reducing photoageing.
Nevertheless, it must be taken into account that most of these studies have been done with a low number of subjects, with combination with other ingredients and/or without placebo group. Thus, well designed clinical trials with a correct volunteer's number are required to obtain robust results about the effects of FMPBE on skin ageing.
Dérivés Résiniques et Terpéniques (DRT) is a company that has developed and commercialize Oligopin®, a polyphenol extract derived from French maritime pine bark. Oligopin® is characterized by a practical absence of tannins ( < 1%) and a high content in low molecular weight oligomeric procyanidins (OPC > 70%; dimers about 20%), a distinctive feature of other proanthocyanidin-rich extracts such as Pycnogenol® which contained about 5% of dimers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 35 years or more age.
- •Fitzpatrick skin phototype II-IV.
- •Signed informed consent.
排除标准
- •Present intolerances and/or food allergies related to Oligopin®.
- •Being pregnant or intending to become pregnant.
- •Be in breastfeeding period.
- •Be a smoker.
- •Participate in or have participate in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- •Present some chronic gastrointestinal disease.
- •Present some chronic disease with clinical manifestation.
- •Receive or are planning to receive facial cosmetic procedures such as facial peel, dermabrasion, laser treatments within six months prior to start the study.
- •Take supplements or multivitamin supplements or phytotherapeutic products that interfere with the treatment under study up to 30 days before the start of the study.
- •Has or are planning to take acne treatments, photoaging treatments or topical prescription products indicated for improving the appearance or condition of skin within 30 days.
- •Present any skin disease (e.g., atopic skin, eczema, neurodermatitis or psoriasis) or other dermatological disorders (e.g., scars, sunburn or moles).
- •Intensive sun or artificial UV exposure (solarium) on the test area within 30 days prior to study start or planned during the study period.
- •Being unable to follow the study guidelines.
结局指标
主要结局
Change in skin elasticity
时间窗: At weeks 2, 3 and 4
Skin elasticity measured by using a Cutometer® MPA 580
次要结局
- Change in skin hydratation(At weeks 2, 3 and 4)
- Capacity of Oligopin® blood metabolites to modulate collagen levels(At week 1)
- Change in biomarkers of collagen and elastin dynamics in serum(At weeks 2 and 4)
- Oligopin® long-term blood metabolites characterization(At weeks 2 and 4)
- Transcriptomics in PBMCs(At weeks 2 and 4)
- Capacity of Oligopin® blood metabolites to modulate secreted collagen type I(At week 1)
- Capacity of Oligopin® blood metabolites to modulate TIMP-1 levels(At week 1)
- Capacity of Oligopin® blood metabolites to inhibit MMP-1 activity(At week 1)
- Capacity of Oligopin® blood metabolites to inhibit MMP-9 activity(At week 1)
- Change in skin spots(At weeks 2, 3 and 4)
- Change in subepidermal low-echogenic band(At weeks 2, 3 and 4)
- Change in expression levels of genes related to collagen synthesis and degradation in PBMCs(At weeks 2 and 4)
- Metabolomics in serum(At weeks 2 and 4)
- Capacity of Oligopin® blood metabolites to modulate secreted collagen type III(At week 1)
- Change in skin wrinkles(At weeks 2, 3 and 4)
- Postprandial Oligopin® blood metabolites characterization(At week 1)
- Effect of Oligopin® blood metabolites on collagen fibers cross-linking(At week 1)
- Capacity of Oligopin® blood metabolites to modulate pyruvate target genes(At week 1)
- Capacity of Oligopin® blood metabolites to modulate MMP-1 activity(At week 1)
- Capacity of Oligopin® blood metabolites to inhibit MMP-2 activity(At week 1)