Dietary Intervention on Atopy

Обзор

Diet is a key determinant of overall health, with growing evidence associating dietary patterns with allergic diseases. Among these, atopic dermatitis (AD) is of particular interest as it often represents the earliest manifestation of the atopic triad. Investigating dietary interventions in AD therefore provides a relevant model to better understand how diet may influence the onset and progression of allergic disease more broadly.

Подробное описание

Atopic dermatitis (AD) is a chronic inflammatory skin disease that frequently persists into adulthood and substantially impairs quality of life, sleep, and psychosocial well-- being. While pharmacological therapies remain central to management, in- complete responses and concerns regarding long-- term use have prompted interest in complementary, non-- pharmacological strategies. Dietary modification has emerged as a potentially modifiable adjunct; however, adult intervention trials remain limited and have predominantly focused on single-- nutrient supplementation or elimination-- based approaches rather than whole-- diet modification. Evidence from Asian adult populations is particularly scarce.

Building on our prior epidemiological findings demonstrating that frequent intake of saturated fat (SFA)-- rich foods was as- sociated with higher odds of AD exacerbation, whereas greater consumption of fruits, vegetables and dietary fibre was associ- ated with lower odds, we aim to conduct a pilot, parallel-- arm, assessor--blinded randomised controlled trial (RCT). The RCT evaluated whether a culturally adapted healthy dietary pat- tern (HDP), aligned with Singapore's My Healthy Plate (MHP) guidelines, could reduce AD severity as measured by clinical symptoms.

Вмешательства

• Другое Dietary Intervention on Atopy
  The primary aim of this dietary intervention study is to assess the effectiveness of a dietary pattern characterized by lower saturated fats, higher wholegrains, fruit, and vegetables in reducing the severity of AD in young Singapore adults, as measured by changes in Scoring Atopic Dermatitis (SCORAD) scores, over a 2-month intervention period.

Первичные конечные точки

• Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores) [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]

Вторичные конечные точки (8)

• Change in skin barrier function assessed by bioengineering measures [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Change in dermatology-specific quality of life (DLQI) [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Change in atopic dermatitis-related medication utilisation [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Height and Weight Measurements [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Blood Pressure Measurement [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Blood Lipid-Lipoprotein Profile [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Change in circulating inflammatory markers (cytokines and chemokines) [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]
• Change in gut microbiota diversity and composition [Срок оценки: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up]

Критерии участия

Критерии включения

• Presence of current, mild-to-moderate atopic dermatitis/eczema at flexural areas
• 21 to 65 years of age (inclusive) at screening
• Must be English-literate and able to give informed consent in English
• Be residing in Singapore and will not be travelling outside of Singapore during the study period
• Reliable and willing to follow study procedures and be available for the duration of the study
• Non-smokers (tobacco and e-cigarette)
• Non-drinker (no regular or frequent consumption of alcohol)
• Overtly healthy with no pre-existing medical conditions (e.g., diabetes, hypertension, cancer, blood disorders, degenerative/liver/autoimmune/immune/renal diseases, or psychiatric conditions)
• No food allergies to test foods
• No needle phobia
• Be willing to follow the instruction provided by the investigators on the use of any moisturiser, cosmetics, and/or topical cream on the skin throughout the entire duration of the study.

Критерии исключения

• Concurrent participation in other research studies
• Pregnancy or lactating individuals
• Known or ongoing psychiatric disorders within 3 years
• Known severe nutritional deficiency
• Vegetarian/vegans (as meat will be included in the diet)
• Individuals who made a significant dietary change in the past 12 months
• Having a pre-existing dietary restriction that would interfere with the adherence to a whole diet meal
• Regular use of strong medication (western and/or traditional), therapies, and alternative medications
• Regular nutritional supplements in the past 12 months Regular consumption of oral contraceptive pills and/or steroid hormones
• Antibiotic use in the past 2 months
• Any long-term hospitalisation or surgery during the 6 months before enrolment in study
• Significant change in weight (+/- 5.0%) during the past month
• History of bleeding diathesis or coagulopathy (or any bleeding disorders)
• Having donated blood of more than 500 mL within 4 weeks of study enrolment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Сингапур · 1 центр

• National University of Singapore — Singapore

Идентификаторы

NCT: NCT06547372 · NUS-IRB-2024-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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