Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Total antioxidant capacity in skin biopsies
Time frame: Day 0, Day 112
Total antioxidant capacity in skin biopsies
Time frame: Day 0, Day 56
Total antioxidant capacity in buccal mucosa cells (BMCs)
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Total antioxidant capacity in plasma
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Plasma levels of vitamin C and E and carotenoids
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Levels of vitamin E and carotenoids in skin biopsies
Time frame: Day 0, 56, 112
Levels of vitamin E and carotenoids in BMCs
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Number of subjects with adverse events
Time frame: up to 119 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 112
Assessment of tolerability by volunteers on a 4-point scale
Time frame: Day 112
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 112 days
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