An interventional study of Dietary Intervention on Atopy in Atopic Dermatitis, Atopic and Allergic Diseases, sponsored by National University of Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by National University of Singapore · Not applicable, Interventional, and Treatment
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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 110 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →National University of Singapore is the lead sponsor of 212 studies on the registry; 54 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Dietary Intervention on Atopy
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.
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.
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.
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 months (intervention period), and 1 month post-intervention follow-up
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Started May 2024 (actual). Primary completion is estimated for Dec 2027, 43 months after the start.
Of 113 non-industry interventional studies with no phase under Dermatitis, Atopic, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 43 months is above that.
Counting every sponsor, half of 182 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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