The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.
Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
Parallel
Placebo SoftGel
Dietary supplementThe food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active SoftGel Supplement
Dietary supplementThe food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active Comparator Powder
Dietary supplementActive supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.
Placebo Powder
Dietary supplementActive supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
Skin aging hallmarks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
Incidence of adverse events
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Amazentis SA
Lead sponsor
MS Clinical Research Pvt. Ltd
Collaborator
