NCT04013945

Study to Investigate the Effect of Superba Boost on the Skin.

A Randomised, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Effect of Superba Boost (Krill Oil Concentrate) on Various Skin Parameters in Healthy Adult Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Aker BioMarine Human Ingredients AS · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Study to determine the effect of 12 weeks daily consumption of Superba Boost as compared to placebo on changes in Trans-Epidermal Water-Loss (TEWL).

Detailed description

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 TEWAmeter, 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.

Conditions

• Physiology, Skin

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Superba Boost (Active)	To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Superba Boost.
DIETARY_SUPPLEMENT	Vegetable oil (Placebo)	To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Placebo.

Timeline

• Start date: 2019-03-13
• Primary completion: 2019-08-12
• Completion: 2020-03-22
• First posted: 2019-07-10
• Last updated: 2023-02-01

Locations

1 site across 1 country: Ireland