Health TrialsbyHealthPanel

A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function

ConditionSkin Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorEpax Norway AS

About this trial

The primary objective of the study is to determine the benefits of the food product EPAX Omega 3-9-11 on skin function.

Benefits (if any) will be determined by evaluating biophysical measurements of the face and inner forearm. Moreover, the study will determine the dosage effect of Omega-3-9-11 on these measurements.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Volunteers who are able to provide signed informed consent

Healthy male or female volunteers between the ages of 35 and 65 years

Volunteers with a self-perceived history of atopic skin, prone to redness and/or dryness

Disqualifiers

Females who are pregnant, breast feeding, or have given birth within the previous 6 weeks or are planning to be pregnant during the study

Volunteers with previous experience of intolerance or allergic reactions to fish or fish products

Volunteers with an active skin disorder or a significant history of skin disorders (e.g. psoriasis, eczema, vitiligo, pityriasis versicolor, acne) which in the opinion of a trained assessor or dermatologist may affect the test results

Volunteers currently taking or who have recently taken antihistamines, antibiotics, systemic anti-inflammatory drugs during the previous week

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omega 3-9-11

    Dietary supplement

    Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.

  • Placebo

    Dietary supplement

    Corn oil capsules

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Low doseExperimental treatment 2 interventions
Group C: High doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Erythema

1\. Facial erythema measured using the validated erythema image analysis algorithm within the quantitative measurement system of the Visia CRII image analysis system. Comparison of erythema area (pixels on erythema algorithm map) in pre and post analysis situations will be evaluated statistically for mean and median changes across the study cohort.

Time frame
3 months intervention
2

Skin hydration

2\. Transepithelial water loss will be measured using a non-invasive Tewameter. Values are given as g/m2/hour, higher values relate to increased water loss. Measurements will be made pre and post intervention (for doses together and separately) compared to placebo

Time frame
3 months intervention

Secondary outcomes

1

Skin parameters, placebo adjusted

1\. Facial erythema measured using VISIA facial analysis system and Tewameter, placebo adjusted values between dosing groups.

Time frame
3 months intervention
2

Skin health by Omega-3 index

4\. Primary and secondary measurements as a function of omega-3 index. Omega-3 index is the measurement of EPA and DHA as a % of total lipid in red blood cells.

Time frame
3 months intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Epax Norway AS

Lead sponsor

Cutest Systems Ltd

Collaborator

Source ClinicalTrials.gov
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