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Skin AgingOLIGOSKINNCT04141059

Effect of Oligopin® on Skin Ageing

A study testing Oligopin in people with Skin Aging, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.

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

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. Read more about this study

Who is it for?
Ages 35 years and olderHealthy volunteers can take part
Conditions the study is for
Skin Aging
What is being tested?
Oligopin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteSpain
Study dates
19 Nov 2019to 10 Sep 2020
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 35 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

    Reus, Tarragona, 43204

Other trials in Spain

About this study

Official title: Effect of a French Maritim Pine Bark Extract Oligopin® on Skin Ageing. Double Blind, Parallel, Randomized, Placebo Controled Intervention Trial

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.

Read the detailed description

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.

Furthermore, although the insoluble products in water are low in both products, lower and more adequate concentrations are present in Oligopin® (Oligopin ® typically 2 to 4% to a maximum at 5% versus Pycnogenol®: 6% - 8.1%).

The degree of polymerization of OPC can determine its absorption across cell membranes and, as it has been observed in rats, only a certain OPC of a lower degree of polymerization is absorbed during transit in the gut. Consequently, the effect of FMPB extract could be determined, in part, by the quality of its OPC.

The hypothesis of the present study is that circulating metabolic fraction of Oligopin® might exert beneficial actions on collagen metabolism, which is directly linked to skin strength and elasticity.

In consequence, the daily consumption of Oligopin® will exert beneficial effects on skin ageing through the modulation of the proteins involved in the metabolism of collagen in humans.

The main objective of the study is to determine the beneficial effects of Oligopin® on skin aging, through the improvement of skin elasticity in participants with photo-aging.

The secondary objectives of the study are:

  • To evaluate the effects of Oligopin® on skin aging through the measurement of wrinkles, spots, skin hydration and subepidermal band.
  • To evaluate the effects of Oligopin® on the dynamics of collagen and elastin through the determination of different biomarkers in serum and the expression of genes in peripheral blood mononuclear cells (PBMCs).
  • To discover new biomarkers of the effects of Oligopin® through transcriptomic analysis in PBMCs and serum metabolomic analysis.
  • To characterize the metabolites of Oligopin® (MFO) in plasma.
  • To establish potential correlations between specific metabolites of MFO and the beneficial effects of Oligopin® on the skin, as well as between serum biomarkers and PBMC.
  • To evaluate the ability of the MFO to modulate the dynamics of collagen through the use of cellular models of human fibroblasts.

In an initial phase, an acute postprandial study will be carried out with 20 of the 60 volunteers with the consumption of 700 mg of Oligopin® in a single day, with the aim of obtaining the MFO. With MFO, the mechanisms by which Oligopin® exerts the beneficial effects on skin aging will be studied through in vitro studies with cellular models. The 60 participants will participate in the second phase of the study, which will be randomly divided into two groups of 30 participants, depending on whether they consume a 100 mg Oligopin® capsule or a placebo capsule, with the same appearance as the Oligopin® capsule but will not contain the botanical extract. In this second phase, participants will consume one capsule each day for a total of 6 weeks.

During the study there will be 5 visits, one of selection (V0), one of the first phase of the study (V1; week 1) and 3 visits of the second phase of the study (V2, V3 and V4; weeks 2, 3 and 4).

Conditions
Skin Aging
Being tested
Oligopin, Placebo
Keywords
Photoaging, Polyphenols, Natural extracts, Collagen metabolism

What participants receive

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

  • OligopinDietary supplement

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

  • PlaceboDietary supplement

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

Study groups in NCT04141059
Study groupRoleWhat they receive
OligopinExperimentalIntervention group that will intake 100 mg of Oligopin® for 6 weeks
Receives: Dietary Supplement: Oligopin
PlaceboPlacebo comparatorPlacebo group that will intake 250 mg of Maltodextrin
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Change in skin elasticity

    Skin elasticity measured by using a Cutometer® MPA 580

    Measured: At weeks 2, 3 and 4

Secondary outcomes (20)
  1. Change in skin wrinkles

    Skin wrinkles measured using DermoPrime System

    Measured: At weeks 2, 3 and 4

  2. Change in skin hydratation

    Skin hydratation measured using DermoPrime System

    Measured: At weeks 2, 3 and 4

  3. Change in skin spots

    Skin spots measured using DermoPrime System

    Measured: At weeks 2, 3 and 4

  4. Change in subepidermal low-echogenic band

    Subepidermal low-echogenic band measured by ultrasound echogenicity quantitative approach

    Measured: At weeks 2, 3 and 4

  5. Change in biomarkers of collagen and elastin dynamics in serum

    Serum levels of Human Procollagen I N-Terminal Propeptide, Human Procollagen I C-Terminal Propeptide, Human C-Telopeptide of Type I Collagen, Fibronectin, Elastin, Hyaluronic acid, MMP-1, TIMP-1. These biomarkers will be measured using humans ELISA kits.

    Measured: At weeks 2 and 4

  6. Change in expression levels of genes related to collagen synthesis and degradation in PBMCs

    Expression levels in PBMCs by quantitative polymerase chain reaction (qPCR) of the following genes: Collagen type I alpha 1 chain gene (Col1a1), Collagen type I alpha 2 chain gene (Col1a2), Mmp-2, Timp-1.

    Measured: At weeks 2 and 4

  7. Oligopin® long-term blood metabolites characterization

    Oligopin® blood metabolites will be measured by liquid chromatography quadruple Time-of-Flight (LC-qTOF). It will be analyzed the correlations between specific Oligopin® metabolites and its effects on skin, as well as on serum and PBMCs biomarkers.

    Measured: At weeks 2 and 4

  8. Transcriptomics in PBMCs

    Transcriptomics in PBMCs analyzed using microarrays Agilent technologies

    Measured: At weeks 2 and 4

  9. Metabolomics in serum

    Non-targeted metabolomics of aqueous and lipid fraction of serum samples measured using proton nuclear magnetic resonance

    Measured: At weeks 2 and 4

  10. Postprandial Oligopin® blood metabolites characterization

    Postprandial Oligopin® blood metabolites characterization after 700 mg Oligopin® consumption and measured by LC-qTOF. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  11. Capacity of Oligopin® blood metabolites to modulate collagen levels

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of total collagen concentration in cells and cultured media. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  12. Capacity of Oligopin® blood metabolites to modulate secreted collagen type I

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of secreted collagen type I. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  13. Capacity of Oligopin® blood metabolites to modulate secreted collagen type III

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of secreted collagen type III. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  14. Capacity of Oligopin® blood metabolites to modulate pyruvate target genes

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of mRNA levels of pyruvate target genes in cells measuring expression levels of elastin, Col1a1, Col1a2, Col3a1, Mmp-1 and Timp-1 genes. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  15. Capacity of Oligopin® blood metabolites to modulate MMP-1 activity

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of MMP-1 activity in culture medium. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  16. Capacity of Oligopin® blood metabolites to modulate TIMP-1 levels

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of TIMP-1 levels in culture medium. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  17. Capacity of Oligopin® blood metabolites to inhibit MMP-1 activity

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of inhibitory effect on MMP-1. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  18. Capacity of Oligopin® blood metabolites to inhibit MMP-2 activity

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of inhibitory effect on MMP-2. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  19. Capacity of Oligopin® blood metabolites to inhibit MMP-9 activity

    The capacity of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of inhibitory effect on MMP-9. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

  20. Effect of Oligopin® blood metabolites on collagen fibers cross-linking

    The effect of Oligopin® blood metabolites to modulate collagen dynamics using human fibroblast cell line treated with Oligopin® blood metabolites and determination of collagen fibers cross-linking effect. The measurements will be done at 0 hours, 2 hours and 6 hours.

    Measured: At week 1

Timeline

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

  1. First posted28 Oct 2019
  2. Study start19 Nov 2019
  3. Primary completion10 Sep 2020
  4. Study completion10 Sep 2020

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141059
Sponsor's protocol ID
OLIGOSKIN
Acronym
OLIGOSKIN
Status last verified
Mar 2022
First submitted
17 Oct 2019
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oligopin in people with Skin Aging, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.

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 3 inclusion and 13 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 2 Mar 2022. 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 Spain. 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 skin elasticity (time frame: At weeks 2, 3 and 4). 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 2 Mar 2022.

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