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NCT Number: NCT06547372

Dietary Intervention on Atopy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Dietary Intervention on Atopy

Other

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.

Primary outcomes

  1. Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)

    Time frame: 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.

Secondary outcomes

  1. Change in skin barrier function assessed by bioengineering measures

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome evaluates changes in skin barrier function using objective bioengineering measurements, including skin hydration, transepidermal water loss (TEWL), pH, and sebum levels. These parameters capture key physiological aspects of atopic dermatitis (AD) beyond clinical severity.

    Measurements will be obtained using standardized instruments: Tewameter® (TEWL; g/h/m²), Corneometer® (skin hydration via relative permittivity), Skin-pH-Meter PH® (surface pH), and Sebumeter® (sebum content; 0-350 scale). Assessments will be conducted at predefined anatomical sites corresponding to SCORAD evaluation areas.

    Participants demonstrating improvement will be defined based on directional changes toward normalized values across these parameters, enabling an objective assessment of skin barrier recovery following the intervention.

  2. Change in dermatology-specific quality of life (DLQI)

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome assesses the impact of the dietary intervention on participants' quality of life using the Dermatology Life Quality Index (DLQI), a validated 10-item instrument measuring the effect of skin disease on daily functioning and psychosocial well-being.

    DLQI scores range from 0 to 30, with higher scores indicating greater impairment. Changes in DLQI will be evaluated alongside clinical severity (SCORAD) to provide a more comprehensive assessment of intervention effects. A reduction of ≥4 points will be considered the minimal clinically important difference (MCID), consistent with established thresholds.

  3. Change in atopic dermatitis-related medication utilisation

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome evaluates changes in the use of AD-related medications as an indicator of disease control and treatment burden. Medication use will be recorded for both maintenance therapies (e.g., moisturizers, topical preparations) and symptom-control treatments (e.g., topical/oral corticosteroids, antihistamines).

    Frequency of use will be categorized as: never/rarely (<1 day/week), occasionally (1-2 days/week), or most/all days (≥3 days/week). An aggregate medication utilisation score, adapted from validated scoring systems in allergic disease research, will be computed to quantify overall treatment use.

    Reductions in medication utilisation will be interpreted as supportive evidence of improved disease control in response to the dietary intervention.

  4. Height and Weight Measurements

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    Anthropometric outcomes will be assessed as separate measures. Height (cm): Height will be measured using a calibrated stadiometer and recorded in centimeters.

    Weight (kg): Weight will be measured using a calibrated digital scale and recorded in kilograms.

    Body Mass Index (BMI, kg/m²): BMI will be calculated as weight (kg) divided by height squared (m²) and classified according to Asian-specific criteria. Changes in BMI will be used as an aggregate indicator of overall anthropometric status.

  5. Blood Pressure Measurement

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome assesses systolic blood pressure (mmHg) and diastolic blood pressure (mmHg). Measurements will be taken in duplicate using a validated automated sphygmomanometer under standardized conditions.

  6. Blood Lipid-Lipoprotein Profile

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome evaluates changes in fasting lipid parameters. Venous blood samples will be collected after a 10-12 hour fast and analyzed for serum total cholesterol, triglycerides, and HDL cholesterol (mmol/L) using enzymatic methods. LDL cholesterol will be estimated using the Friedewald equation. Together, these parameters characterize the lipid-lipoprotein profile.

  7. Change in circulating inflammatory markers (cytokines and chemokines)

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome evaluates changes in systemic immune function through circulating cytokine and chemokine levels. Fasting venous blood samples (15 mL) will be collected in EDTA tubes and processed by centrifugation to isolate plasma.

    Plasma samples will be aliquoted and analyzed for a panel of inflammatory protein markers, including cytokines and chemokines relevant to atopic dermatitis and immune regulation. Changes in marker concentrations over time will be used to assess the immunomodulatory effects of the dietary intervention.

  8. Change in gut microbiota diversity and composition

    Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up

    This outcome assesses changes in gut microbiota profiles in response to the dietary intervention. Stool samples (~10 mm³) will be collected at baseline, day 28, day 56, and day 84 using standardized procedures to preserve microbial integrity.

    Microbial DNA will be extracted using validated commercial kits, and 16S rRNA gene sequencing will be performed to characterize bacterial taxa. Microbiota changes will be evaluated using:

    Alpha diversity (within-sample diversity), reflecting richness and evenness of microbial communities Beta diversity (between-sample differences), reflecting shifts in overall community composition.

    These measures will be used to examine whether dietary modification is associated with changes in gut microbial ecology, which may influence systemic inflammation and AD outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Jie Lim, PhD

CONTACT

[email protected]

65161685 ext. (+65)

Mei Hui Liu, PhD

CONTACT

[email protected]

65163523 ext. (+65)

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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