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

Epax

Status: Enrolling

Conditions: Skin Health

Treatments: Dietary Supplement: Omega 3-9-11; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07133477

AN3991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1g corn oil capsules

Treatment:

Dietary Supplement: Placebo

Low dose

Experimental group

Description:

Subjects will receive 2g of Omega 3-9-11 oil

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: Omega 3-9-11

High dose

Experimental group

Description:

Subjects will receive 4g of Omega 3-9-11 oil

Treatment:

Dietary Supplement: Omega 3-9-11