Omega 3-9-11: Fish oil capsules containing a fish oil concentrate from North Atlantic fish species containing EPA / DHA / cetoleic acid and gondoic in controlled amounts.
Placebo: Corn oil capsules
Study summary
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
Sex
ALL
Min age
35 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Volunteers currently taking or who have recently taken retinoids, immunosuppressive drugs, anti-cancer drugs during the six previous months
* Volunteers who have started, stopped or changed hormonal treatment (including contraceptive pills) in the five previous weeks
* Volunteers whose skin has been exposed to excessive levels of sun or UV rays during the previous month
* Volunteers who are suffering from chronic asthma, a malfunction of the lymphatic system, or an auto immune deficiency disease (e.g. lupus, thyroiditis)
* Volunteers with a history of skin tumours or malignant disease
* Volunteers who have participated in any clinical study involving the test sites within the previous month
* Volunteers taking fish oil supplements or other lipid-based supplements regularly during the last 4 weeks
Primary outcome measure(s)
Erythema — 3 months intervention 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.
Skin hydration — 3 months intervention 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
Trial sites (1)
Facility
City
Region
Status
Cutest Systems Ltd
Cardiff
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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