Atopic DermatitisNCT06547372
Dietary Intervention on Atopy
A study testing Dietary Intervention on Atopy in people with Atopic Dermatitis and Atopic, run by National University of Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Atopic Dermatitis, Atopic, Allergic Diseases
- What is being tested?
- Dietary Intervention on Atopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSingapore
- Study dates
- 10 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore, Singapore, 118177
Jun Jie Lim, PhD, 65161685 ext. +65, limjj@nus.edu.sg
Nur Hafizah Binte Mohamed Yusri, MSc., 6594558400, hafizahy@nus.edu.sg
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Atopic, Allergic Diseases, Allergic Rhinitis
- Being tested
- Dietary Intervention on Atopy
- Keywords
- Atopic dermatitis, My Healthy Eating Plate, eczema, healthy diet, diet, meals, foods, allergic, allergy, atopic, Singapore, nutrients
- Medical subject headings
- Dermatitis, Atopic, Rhinitis, Allergic, Eczema, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention on AtopyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Dietary Intervention on Atopy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Secondary outcomes (8)
Change in skin barrier function assessed by bioengineering measures
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in dermatology-specific quality of life (DLQI)
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in atopic dermatitis-related medication utilisation
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Height and Weight Measurements
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Blood Pressure Measurement
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Blood Lipid-Lipoprotein Profile
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in circulating inflammatory markers (cytokines and chemokines)
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in gut microbiota diversity and composition
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.
Measured: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 May 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEW Fook Tim, National University of Singapore
- Investigators
- Fook Tim CHEW, PhD, Principal investigator, NUS Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547372
- Sponsor's protocol ID
- NUS-IRB-2024-28
- Status last verified
- Oct 2025
- First submitted
- 2 Aug 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention on Atopy
- ClinicalTrials.gov ID
- NCT06547372
- Acronym / sponsor ID
- NUS-IRB-2024-28
- Conditions
- Atopic Dermatitis, Atopic, Allergic Diseases, Allergic Rhinitis
- Keywords
- Atopic dermatitis, My Healthy Eating Plate, eczema, healthy diet, diet, meals, foods, allergic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Dietary Intervention on AtopyThroughout 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention on AtopyThe 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. | Other | Intervention |
Primary outcome
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.
8 secondary outcomes
Change in skin barrier function assessed by bioengineering measures
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in dermatology-specific quality of life (DLQI)
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in atopic dermatitis-related medication utilisation
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Height and Weight Measurements
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Blood Pressure Measurement
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Blood Lipid-Lipoprotein Profile
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in circulating inflammatory markers (cytokines and chemokines)
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Change in gut microbiota diversity and composition
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fook Tim CHEW, PhD principal investigator
NUS Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention on Atopy in people with Atopic Dermatitis and Atopic, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Hui Liu, PhD (65163523 ext. (+65), fstlmh@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores) (time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.