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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05128240
Other study ID # P237921
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 23, 2021
Est. completion date March 1, 2022

Study information

Verified date November 2021
Source Epax Norway AS
Contact Derek Tobin, PhD
Email derek.tobin@pelagia.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.


Description:

Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 1, 2022
Est. primary completion date December 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: Healthy women in the age of 30-65 Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention): - Do not take omega-3 supplements - do not take supplements containing vitamin A - do not take supplements containing collagen - try to avoid using skin products containing vitamin A - do not undergo skin treatment Exclusion Criteria: Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period -

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo
1g corn oil capsules
Ceto 10
1g capsules containing oil broad spectrum marine oil from north atlantic fish

Locations

Country Name City State
Norway Møreforsking AS Ålesund

Sponsors (2)

Lead Sponsor Collaborator
Epax Norway AS Møreforsking AS

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the change in skin quality of healthy women after supplementation with fish oil compared to corn oil Changes in quantitative analysis of facial inflammation, wrinkles and fine lines and skin texture will be performed using the VISIA Skin Analysis system. Measurements will be made at baseline and at end of supplementation period. 3 months
Secondary Determine the change in omega-3 index (%EPA and DHA in red blood cells) after daily intake of 4g of north atlantic fish oil compared to placebo Fatty acid profiles will be measured from blood samples using the Omega-quant test 3 months
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