Effect of Oligopin® on Skin Ageing

NCT04141059 | Completed

• 1 other identifier: OLIGOSKIN
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Aging

Keywords

Photoaging; Polyphenols; Natural extracts; Collagen metabolism

Outcome Measures

Primary Outcomes (1)

• Change in skin elasticity

  Skin elasticity measured by using a Cutometer® MPA 580

  At weeks 2, 3 and 4

Secondary Outcomes (20)

• Change in skin wrinkles

  At weeks 2, 3 and 4

• Change in skin hydratation

  At weeks 2, 3 and 4

• Change in skin spots

  At weeks 2, 3 and 4

• Change in subepidermal low-echogenic band

  At weeks 2, 3 and 4

• Change in biomarkers of collagen and elastin dynamics in serum

  At weeks 2 and 4

Study Arms (2)

Oligopin

EXPERIMENTAL

Intervention group that will intake 100 mg of Oligopin® for 6 weeks

Dietary Supplement: Oligopin

Placebo

PLACEBO COMPARATOR

Placebo group that will intake 250 mg of Maltodextrin

Dietary Supplement: Placebo

Interventions

Oligopin DIETARY_SUPPLEMENT

Oligopin capsules composition is :100 mg Oligopin®, 150 mg Maltodextrin, 1.5 mg Mg stearate.

Oligopin

Placebo DIETARY_SUPPLEMENT

Placebo capsules composition is: 250 mg Maltodextrin and 1.5 mg Mg stearate

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 35 years or more age.
• Fitzpatrick skin phototype II-IV.
• Signed informed consent.

You may not qualify if:

• Present intolerances and/or food allergies related to Oligopin®.
• Being pregnant or intending to become pregnant.
• Be in breastfeeding period.
• Be a smoker.
• 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.

Sponsors & Collaborators

• Technological Centre of Nutrition and Health, Spain: lead
• Fundació Eurecat: collaborator
• Hospital Universitari Sant Joan de Reus: collaborator
• University Rovira i Virgili: collaborator
• Les Dérivés Résiniques et Terpéniques (DRT) S.A.S.: collaborator

Study Sites (1)

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Reus, Tarragona, 43204, Spain

Location

Related Links

• Technological Centre of Nutrition and Health. Eurecat\_Reus.

MeSH Terms

Interventions

Oligopin

Study Officials

• Rosa Solà, Dr

  UTNS (Eurecat_Reus)/HUSJR. Reus, Tarragona, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 28, 2019
• Study Start: November 19, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)