Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-01 @ 11:08 AM
Study NCT ID:
NCT05711303
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Effect of Superba Boost on the Skin
Sponsor:
Atlantia Food Clinical Trials
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
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 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.
Each subject must fulfill all inclusion criteria and will not be allowed to meet any of the exclusion criteria.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: