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| Name | Class |
|---|---|
| Cutest Systems Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1g corn oil capsules |
|
| Low dose | Experimental | Subjects will receive 2g of Omega 3-9-11 oil |
|
| High dose | Experimental | Subjects will receive 4g of Omega 3-9-11 oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months intervention |
| 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 | 3 months intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Skin parameters, placebo adjusted | 1. Facial erythema measured using VISIA facial analysis system and Tewameter, placebo adjusted values between dosing groups. | 3 months intervention |
| Skin health by Omega-3 index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cutest Systems Ltd | Recruiting | Cardiff | United Kingdom |
Per patient data will be shared to relevant researchers. All data will be fully anonymised.
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Subjects are randomised in a blinded fashion to one of 3 groups. Placebo, dose 1 and dose 2.
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Subjects will take a total of 4 capsules with a different ratio of fish oil and placebo according to which group they are selected for. Labelling is coded to maintain blinding.
| Placebo | Dietary Supplement | Corn oil capsules |
|
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.
| 3 months intervention |