Dietary Intervention on Atopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)
研究概览
简要总结
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.
详细描述
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.
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
- 否
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 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.
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
研究组 & 干预措施
Control
The control group will not receive the meals provided by our study nor will they receive any nutritional advice. Instead, they will continue following their usual dietary habits and patterns throughout the study period.
Intervention
Throughout the 2-month intervention period, only participants in the intervention arm will be provided with bento-styled meals for lunch and dinner daily. The meals will encompass a variety of nutrient-rich ingredients, including whole grains, lean proteins, an array of fruits and vegetables, and healthy fats. The food will be prepared by a licensed food catering service.
干预措施: Dietary Intervention on Atopy (Other)
结局指标
主要结局
Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)
时间窗: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
This study evaluates whether a dietary pattern lower in saturated fats and higher in whole grains, fruits, and vegetables reduces AD severity in young Singaporean adults over a 2-month period, as measured by changes in Scoring Atopic Dermatitis (SCORAD) scores. The SCORAD index is a validated measure of AD severity that integrates lesion extent, clinical signs (erythema, edema, oozing/crusting, excoriation, lichenification, dryness), and patient-reported symptoms. It quantifies affected body surface areas (e.g., head, limbs, trunk), enabling standardized baseline assessment and sensitive monitoring of changes over time.
次要结局
- Change in gut microbiota diversity and composition(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Change in skin barrier function assessed by bioengineering measures(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Change in dermatology-specific quality of life (DLQI)(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Change in atopic dermatitis-related medication utilisation(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Height and Weight Measurements(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Blood Pressure Measurement(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Blood Lipid-Lipoprotein Profile(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
- Change in circulating inflammatory markers (cytokines and chemokines)(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
研究者
CHEW Fook Tim
Associate Professor
National University of Singapore