Lycopene compositions and methods for protecting skin against ultraviolet radiation
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example 1
Preparation of Lycopene Composition
[0114]The lycopene used throughout the Examples is natural Tomato lycopene by Lycored®.
[0115]Formulation 1: Each capsule (Lyc-044) contained:[0116]Lycopene 8.2 mg[0117]Vitamin E 2.9 mg[0118]Phytofluene and phytoene 3.00 mg[0119]Beta-carotene 0.46 mg[0120]Carnosic Acid 2 mg
[0121]In soft gel capsules which were prepared according to standard procedures known to the skilled artisan.
example 2
Effect of Lycopene Composition in Protection of Healthy Skin from UV-Induced Photo-Oxidative Damage
Methodology
[0122]A multicentre, double blind, placebo controlled parallel group clinical biostudy. After a 5-week run-in period, during which the intake of lycopene-rich foods and antioxidant supplements was restricted, subjects were randomized to receive formulation 1 soft gel capsules (Lyc-044) or identically appearing medium chain triglycerides soft gel capsules as placebo, twice daily for 12 weeks.
Number of Subjects (Planned and Analysed)
[0123]145 subjects completed the study and were analysed.
Diagnosis and Main Criteria for Inclusion
[0124]Healthy males and females, 20 to 55 years of age, with Fitzpatrick skin type I or II, BMI≤30 kg / m2 and healthy eating habits.
Test Product, Dose and Mode of Administration
[0125]Formulation 1 soft gel capsules administered orally twice daily.
Reference Therapy, Dose and Mode of Administration
[0126]Placebo administered orally twice daily.
Duration of ...
example 3
Lycopene, Phtyofluene and Phytoene Levels in the Serum of the Subjects
[0137]Methodology Compliance was measured by the increase in lycopene, phytofluene and phytoene levels during the study.
[0138]At the randomization visit (prior to receiving supplementation), mean lycopene, phytofluene and phytoene levels in the serum of the subjects of the Lyc-044 and placebo groups were similar. A statistically significant increase in mean lycopene, phytofluene and phytoene levels was observed after 4 weeks of treatment and at the end of the study in the Lyc-044 group compared to placebo (FIG. 3).
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