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An Immunonutritional Approach to the Prevention of Skin Cancer

The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032343
Enrollment
90
Registered
2009-12-15
Start date
2008-07-31
Completion date
2010-11-30
Last updated
2013-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

Keywords

Immunosuppression, Ultraviolet radiation, Nickel, Contact hypersensitivity

Brief summary

Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Detailed description

Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans. OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans. STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules. The aim is to quantify the influence of omega-3 PUFA on: 1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses 2. UVR-induced modulation of epidermal Langerhans cell trafficking 3. UVR-induced modulation of levels of immunoregulatory mediators

Interventions

DIETARY_SUPPLEMENTOmega-3 PUFA

One capsule (4g omega-3 PUFA) daily for 3 months

DIETARY_SUPPLEMENTGelatine

One capsule daily for 3 months

Sponsors

University of Manchester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pre-menopausal females * Sun-reactive skin type I / II * Reporting allergy to jewellery with nickel content

Exclusion criteria

* History of atopy * History of skin cancer * History of a photosensitivity disorder * Sunbathing (including sunbeds) in the last 3 months * Pregnancy * History of cardiac disease * Taking photoactive medicine * Not able to eat fish or gelatine * Taking fish oil supplements prior to the study

Design outcomes

Primary

MeasureTime frameDescription
Degree of suppression of nickel-induced contact hypersensitivity3 monthsMeasurement of the erythema of nickel-induced eczema using a reflectance instrument

Secondary

MeasureTime frame
Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers3 months
Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio3 months
Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers3 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026