Dietary Intervention on Atopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Reduction of SCORAD Scores by a Healthy Dietary Pattern
研究概览
简要总结
Dietary habits play an indispensable role in maintaining overall health and well-being. In recent years, emerging research has underscored the importance of dietary factors on a range of diseases which include allergic (atopic) diseases such as atopic dermatitis (AD). Conducting a dietary intervention study related to AD can provide valuable insights into the relationship between diet and the development or management of this particular allergic skin condition.
详细描述
Atopic dermatitis (AD) is a chronic inflammatory skin disease highly associated with xerosis and pruritus, affecting a substantial portion of individuals of all age groups. The European Academy of Allergy and Clinical Immunology (EAACI) Task Force on Diet and Immunomodulation also emphasized the role of dietary patterns as an important indicator to study the risk of allergic diseases. Furthermore, emerging epidemiological findings and randomised controlled trials (RCT) in recent decades strongly suggest that diet may play a pivotal role in not only triggering and exacerbating AD but also in its effective management.
Preliminary cross-sectional findings in a large independent allergic cohort of 13,561 young Chinese Adults from Singapore and Malaysia highlighted that a frequent intake of high-fat foods such as margarine, butter, seafood, and burgers and fast foods is strongly associated with a higher risk of AD. A diet consisting mainly of high-fat foods, or a high-fat diet as shown by a derived amount- and score-based dietary indices was strongly associated with a higher risk for severe AD even controlling for potential confounding factors like age, sex, body mass index (BMI), lifestyle habits, and genetic predisposition. On the other hand, a frequent adherence to a plant-based food dietary pattern consisting of fruit, vegetables, and cereals was associated with a lowered risk of severe AD. Overall, these compelling findings aligned with evidence-based guidelines such as "My Healthy Eating Plate, Singapore", a visual guide designed to promote a balanced and nutritious dietary pattern specific to the Singaporean context.
In conclusion, a whole diet dietary intervention on AD that adhere to established dietary recommendations such as "My Healthy Eating Plate, Singapore", may offer a promising avenue for individuals seeking to i) improve AD symptoms, ii) improve skin health, and iii) improve quality-of-life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 not apply any moisturiser, cosmetics, and/or topical cream on the skin throughout the entire duration of the study.
排除标准
- •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
结局指标
主要结局
Reduction of SCORAD Scores by a Healthy Dietary Pattern
时间窗: 3 months
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. The SCORAD index, a comprehensive and validated tool, is used to assess AD severity by incorporating objective measures of skin lesions, subjective symptoms, and affected body surface extent. SCORAD will assess the percentage of AD in specific body parts (head, neck, limbs, trunk, back) and evaluate the extent and severity of AD by examining erythema, edema, oozing/crusts, excoriation, lichenification, and dryness.SCORAD's standardized and quantitative assessment facilitates accurate baseline characterization and precise monitoring of changes during the intervention.
次要结局
- Number of participants with changes in immune functions as assessed by blood cytokine and chemokine levels.(3 months)
- Number of participants with changes in gene expression profile as assessed by the changes in differentially expressed genes (DEGs).(3 months)
- To determine the impact of an improved dietary pattern on the quality of life of participants with AD, using the Dermatology Life Quality Index (DLQI) in reducing the severity of AD in Singapore adults(3 months)
- Number of participants with improved skin barrier functions as assessed by skin hydration, transpidermal water loss, pH, and sebum level(3 months)
- Number of participants with changes in gut microbiota profile as assessed by the changes in gut microbiota diversity and composition.(3 months)
研究者
CHEW Fook Tim
Associate Professor
National University of Singapore