Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on reduction in Trans-Epidermal Water-Loss (TEWL).
This study is a randomized, double-blind, placebo-controlled, parallel group trial in 70 healthy adult male and female subjects between 20 and 50 years. The primary objective is to assess whether Superba Boost krill oil administered at a dose of 1 g per day for 12 weeks (84 days) has a positive effect on the TEWL, skin hydration and elasticity. At screening, the subjects must have TEWL values of \>10 g/m2/h and \<24.9 g/m2/h when measured by a TWEAmeter, i.e. within the range defined as normal and healthy skin. The change in omega-3 index, defined as EPA and DHA as percentage of total fatty acids in red blood cells, will be measured and correlated to the changes in the skin parameters. The study consists of 4 visits: the screening visit (V1), baseline visit / week 0 / Start of treatment (V2), Interim / Week 6 (V3) and week 12 / end of treatment (V4) . In this study, subjects must have a low habitual consumption of fatty fish and seafood, defined as a frequency of twice per month or less will be recruited. Each subject must fulfill all inclusion criteria and will not be allowed to meet any of the exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
70
To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of intervention using a TEWAMetre.
Atlantia Food Clinical Trials
Cork, Munster, Ireland
To determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on reduction in Trans-Epidermal Water-Loss (TEWL).
Reduction in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of intervention using a TEWAMetre.
Time frame: 12 weeks.
To determine the effect of daily consumption of Superba Boost as compared to placebo on the reduction of Trans-epidermal water loss (TEWL),
Changes in Trans-epidermal water loss (TEWL) from baseline to 6 weeks after start of treatment, using a TEWAMetre
Time frame: 6 weeks.
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration
Changes in skin hydration from baseline (pre-study) to 6 weeks after start of treatment using a Corneometer
Time frame: 6 week
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin hydration
Changes in skin hydration from 6 weeks of treatment until end-of-study using a Corneometer
Time frame: 6 weeks
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness (6 weeks)
Changes in skin firmness from baseline (pre-study) to 6 weeks after start of treatment using a Cutometer
Time frame: 6 weeks
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes in skin firmness
Changes in skin firmness from 6 weeks of treatment until end-of-study using a Cutometer
Time frame: 6 weeks
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To assess the effect of daily consumption of Superba Boost as compared to placebo on changes on subjective evaluation
Subjective evaluation by study subjects, using questionnaires at 6 weeks of treatment
Time frame: 6 weeks
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes on subjective evaluation
Subjective evaluation by study subjects, using visual analogue scale at 12 weeks of treatment lower scores indicating worse outcomes and higher scores indicating better outcomes.
Time frame: 12 weeks
To assess the effect of daily consumption of Superba Boost as compared to placebo on changes on Omega-3 index
Omega-3 index (%), using a blood spot collected by fingerpick
Time frame: 12 weeks