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

Placebo group that will intake 250 mg of Maltodextrin

Skin Aging

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

Oligopin

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

Placebo

Technological Centre of Nutrition and Health. Eurecat_Reus.

Centro Tecnológico de Nutrición y Salud (Eurecat-Reus)

Effect of Oligopin® on Skin Ageing

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

Skin elasticity measured by using a Cutometer® MPA 580

Skin wrinkles measured using DermoPrime System

Skin hydratation measured using DermoPrime System

Skin spots measured using DermoPrime System

Subepidermal low-echogenic band measured by ultrasound echogenicity quantitative approach

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.

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.

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.

Transcriptomics in PBMCs analyzed using microarrays Agilent technologies

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Technological Centre of Nutrition and Health, Spain

Eurecat

Hospital Universitari Sant Joan de Reus

University Rovira i Virgili

Les Dérivés Résiniques et Terpéniques (DRT) S.A.S.

50 subjects with center-involved diabetic macular edema (CI-DME) and scheduled for treatment with intravitreal injection of anti-VEGF agents will receive softgel placebo containing canola oil, 2 capsules per day during the study duration

50 subjects receiving two DiVFuSS softgels per day

50 subjects receiving 4 DiVFuss softgels per day

Center-involved Diabetic Macular Edema (CI-DME)

The adjunctive nutritional supplement will be the multi-component formula used in the Diabetes Visual Function Supplement Study (Western IRB number 1129944 Olympia, WA), containing the macular carotenoids lutein and zeaxanthin, as well as antioxidants (vitamins B1, B12, C, D, E, lipoic acid, coenzyme Q10, resveratrol), omega3 fatty acids (EPA/DHA) and botanical extracts (Pycnogenol™ [patented extract of French maritime pine bark, Pinus pinaster], grape seed and green tea extracts, curcumin).

Diabetes Visual Function Study (DiVFuSS) softgels

Placebo containing canola oil, 2 softgels per day

canola oil placebo softgels, 2 per day

Sound Retina

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Best-corrected visual acuity at entry and conclusion of study

Change in macular subfield thicknesses from baseline to study conclusion

The number of intravitreal anti-VEGDF injections required for treatment of center-involved diabetic macular edema

The number of subjects in each arm requiring adjunctive laser photocoagulation or intravitreal steroids for treatment of CI-DME

ZeaVision, LLC

This will be an investigator initiated, single-clinic/two location, double-blinded prospective study of 150 adult subjects with newly diagnosed CI-DME receiving anti-VEGF injections, with add-on laser and/or steroid as required on follow-up examination (Standard Treatment) versus standard treatment plus adjunctive DiVFuSS supplementation in one of two doses (2 softgels per day - Supplement Treatment Group 1; and 4 softgels per day - Supplement Treatment Group 2). Subjects will be identified and enrolled with informed consent from two retinal specialty practice sites in Washington State (Sound Retina; Tacoma, WA and Olympia, WA). Subjects will be randomized to Standard Treatment; Supplement Treatment Group 1, or Supplement Treatment Group 2.

After enrollment by the study Primary Investigator, a single retinal specialist from each site, masked to subjects' supplement status, will deliver all treatments per his/her usual protocol for treatment of CI-DME based on individual examination findings. Supplements and identically-appearing placebo will be provided by ZeaVision, LLC of Chesterfield, MO.

Coronary Artery Disease

Pycnogenol

University of Zurich

Pycnogenol and Endothelial Function in Coronary Artery Disease

A Double-blind, Randomized, Placebo-controlled, Cross - Over Design, Single Center Study to Evaluate the Effects of Treatment With Pycnogenol® on Endothelial Function in Subjects With Stable Coronary Artery Disease (Pycno2007-003)

pycnogenol/pinus

Effect of Oligopin® on Skin Ageing

Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

Pycnogenol and Endothelial Function in Coronary Artery Disease

Pycnogenol for the Treatment of Lymphedema

Pycnogenol for the Treatment of Lymphedema of the Arm in Breast Cancer Survivors

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