Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05711303
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2019-06-25
Brief Title:
Study to Investigate the Effect of Superba Boost on the Skin
Sponsor:
Atlantia Food Clinical Trials
Organization:
Atlantia Food Clinical Trials
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 gm2h and 249 gm2h when measured by a TWEAmeter ie 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:
None
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?:
None