- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06547372
Dietary Intervention on Atopy
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mei Hui Liu, PhD
- Phone Number: (+65) 65163523
- Email: fstlmh@nus.edu.sg
Study Contact Backup
- Name: Jun Jie Lim, PhD
- Phone Number: (+65) 65161685
- Email: limjj@nus.edu.sg
Study Locations
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Singapore
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Singapore, Singapore, Singapore, 118177
- Recruiting
- National University of Singapore
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Contact:
- Jun Jie Lim, PhD
- Phone Number: +65 65161685
- Email: limjj@nus.edu.sg
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Contact:
- Nur Hafizah Binte Mohamed Yusri, MSc.
- Phone Number: 6594558400
- Email: hafizahy@nus.edu.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in skin barrier function assessed by bioengineering measures
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Change in dermatology-specific quality of life (DLQI)
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Change in atopic dermatitis-related medication utilisation
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Blood Lipid-Lipoprotein Profile
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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.
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Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Change in circulating inflammatory markers (cytokines and chemokines)
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Change in gut microbiota diversity and composition
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Height and Weight Measurements
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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. |
Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Blood Pressure Measurement
Time Frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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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.
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Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fook Tim CHEW, PhD, NUS Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Immune System Diseases
- Respiratory Tract Diseases
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Skin Diseases
- Nose Diseases
- Otorhinolaryngologic Diseases
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Rhinitis
- Dermatitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Hypersensitivity
- Dermatitis, Atopic
- Eczema
- Rhinitis, Allergic
Other Study ID Numbers
- NUS-IRB-2024-28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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