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Previous studies on the association between the development of allergic diseases and diet indicate the involvement of dietary fatty acids (FA) in the acceleration and/or inhibition of allergic diseases. Edible oils contain various FAs, but their composition depends on the materials from which they are extracted. FAs are characterised by the presence or absence of a carbon double bond in their structure; saturated FAs (palmitic acid, stearic acid, etc.) have no carbon double bond, while unsaturated FAs contain at least one carbon double bond. Among the unsaturated FAs, omega-3 FAs (such as alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]) and omega-6 FAs (such as linoleic acid [LA] and arachidonic acid [ARA]) are classified as essential FAs. Various types of bioactivity of dietary essential FAs have been reported in health and disease studies, including immunity, allergy and inflammation. Human studies, for example, have shown an association between the quality of dietary FAs and the incidence of allergic diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Intranasal corticosteroids + oral fatty acids |
|
| Control group | Active Comparator | Intranasal corticosteroids alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral fatty acid | Dietary Supplement | Intervention therapy (treatment group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) and oral supplementation of FAs (550 mg/tablet), vitamin B6 (0.21 mg/tablet), perilla frutescens (20 mg/tablet) and liquorice (200/mg/tablet) (2 tablets a day with meals) |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic evaluation | Endoscopic evaluation of the nose using the Lund-Kennedy (LK) score.THe LK scoring system is based on the degree of polyps, discharge and edema in each nostril. | From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start) |
| Symptoms and quality of life evaluation, VAS | Symptoms and quality of life evaluation using the Visual Analog Scale (VAS, range 0-10; >5= uncontrolled disease) | From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start) |
| Symptoms and quality of life evaluation, MiniRQoLQ | Symptoms and quality of life evaluation using the Visual Analog Scale (VAS, range 0-10; >5= uncontrolled disease) and Mini Rhinoconjuctivitis Quality of Life Questionnaire (MiniRQoLQ, which utilizes a 7-point scale for each of its 14 questions, ranging from 0 (not impaired at all) to 6 (severely impaired), ranging 0-84). | From the enrolment (T0, baseline, diagnosis) to T1 (90 days after the diagnosis and treatment start) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isola Tiberina Hospital | Rome | Italy | 00186 | Italy |
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|
| Mometasone Furoate Nasal Spray (MFNS) | Drug | Standard therapy (control group) daily treated for 90 consecutive days by INCs (mometasone furoate; 1 puff in each nostril, twice a day) only |
|
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
| D010254 | Paranasal Sinus Diseases |
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| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| ID | Term |
|---|---|
| D008055 | Lipids |
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