A Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omega 3-9-11, Placebo.
- Who it may be relevant to
- Registry conditions: Skin Health. Basic parameters: 35 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomised, Placebo-Controlled Study to Evaluate the Effect of Fish Oil Concentrate on Skin Function
Overview
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.
Detailed description
The long chain mono-unsaturated fatty acids, cetoleic acid (C22:1 n-11) and gondoic acid (C20:1 n-9) found in some North Atlantic fish have been shown to lower inflammatory markers. This has been shown in preclinical studies with particular effect in adipose tissue, and in a human clinical study measuring redness of the face. Omega-3 is also known for reducing skin erythema evoked as a response to UVB exposure, and to decreasing systemic inflammatory biomarkers.
This provides a hypothesis that a combination oil with known bioaccumulation in both subcutaneous fat and in dermal/epidermal layers will contribute to healthy skin function, as shown by a reduction in inflammatory markers and skin erythema and improved barrier function.
The study will recruit subjects to one of 3 arms, a placebo, a low dose and a high dose of omega 3-9-11. Subjects will receive capsules for 3 months and undergo a series of measurements at baseline, 6 weeks and 12 weeks.
Interventions
- Dietary supplement 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. - Dietary supplement Placebo
Corn oil capsules
Primary outcome measures
- Erythema [Time frame: 3 months intervention]
- Skin hydration [Time frame: 3 months intervention]
Secondary outcome measures (2)
- Skin parameters, placebo adjusted [Time frame: 3 months intervention]
- Skin health by Omega-3 index [Time frame: 3 months intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- Cutest Systems Ltd — Cardiff
Identifiers
NCT: NCT07133477 · AN3991