Dietary Intervention on Atopy
NCT Number: NCT06547372
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis|Atopic
Interventions: OTHER: Dietary Intervention on Atopy
Sponsor: National University of Singapore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-10
Completion Date: 2025-04-30
Locations: National University of Singapore, Singapore, 118177, Singapore

Summary:
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.

Primary Outcome Measures: Reduction of SCORAD Scores by a Healthy Dietary Pattern, 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., 3 months
Secondary Outcome Measures: 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, The DLQI serves as a valuable metric to gauge the psychological impact of AD on individuals' daily lives. As AD not only affects the skin but also the overall well-being, assessing the intervention's influence on participants' quality of life (QOL) is essential. By incorporating DLQI alongside SCORAD scores, it can comprehensively evaluate the holistic effects of the improved dietary pattern intervention.

DLQI is computed by assigning scores to 10 questions related to the impact of skin disease on different aspects of daily life, with a total score ranging from 0 to 30, where higher scores indicate a greater impairment of QOL. A DLQI score of 4 is recommended for the threshold for MCID even though it varies from 3 to 5., 3 months|Number of participants with improved skin barrier functions as assessed by skin hydration, transpidermal water loss, pH, and sebum level, Measuring skin parameters provides an objective evaluation of the physiological aspect of AD. Each AD participant will be assessed using four bioengineering devices: Tewameter® (measuring transepidermal water loss (TEWL) in g/h/m² by the density gradient of water evaporation), Corneometer® (measuring relative permittivity (F/m) of upper skin layers), Skin-pH-Meter PH® (measuring skin surface pH on a scale of 1-11), and Sebumeter® (measuring sebum content in units from 0-350 based on light transmission through a special tape). Measurements will be taken from predetermined areas assessed using SCORAD., 3 months|Number of participants with changes in immune functions as assessed by blood cytokine and chemokine levels., Participants in the intervention group will follow a specified dietary pattern, while the control group will maintain regular dietary habits. A total of 5mL whole blood samples will be collected and multiplex assays will then be conducted to analyze multiple cytokines simultaneously in each sample., 3 months|Number of participants with changes in gene expression profile as assessed by the changes in differentially expressed genes (DEGs)., Examining gene expression changes in response to an improved dietary pattern in AD can reveal potential molecular targets, offering insights into personalized treatment and the link between genetics and diet in AD pathogenesis. Functional enrichment analysis will further elucidate the biological processes, pathways, and molecular functions associated with differentially expressed genes (DEGs). Participants in the intervention group will follow a specified dietary pattern, while the control group will maintain regular dietary habits. Peripheral blood mononuclear cells (PBMCs) will be isolated from whole blood samples via centrifugation. High-throughput RNA sequencing will analyze the transcriptome before and after dietary intervention., 3 months|Number of participants with changes in gut microbiota profile as assessed by the changes in gut microbiota diversity and composition., The gut microbiota significantly impacts immune homeostasis and inflammatory skin conditions like AD. Dietary patterns influence the gut microbiome, offering a way to modulate systemic inflammation in AD. Stool samples (approx. 10mm³) will be collected from participants at baseline, day 28, day 56, and day 84 to track changes over time. Standard collection procedures will preserve microbial diversity. Participants in the intervention group will follow a specified dietary pattern, while the control group will maintain regular dietary habits. Microbial DNA will be extracted from stool samples using commercial kits, and 16S rRNA gene sequencing will identify and quantify bacterial taxa. The sequencing will assess alpha diversity (within-sample microbiota composition) and beta diversity (between-sample variation)., 3 months