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Clinical Trials/NCT06547372
NCT06547372RecruitingNot Applicable

Dietary Intervention on Atopy

National University of Singapore1 site in 1 country110 target enrollmentStarted: May 10, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
110
Locations
1
Primary Endpoint
Healthy Dietary Intervention in Treating Atopic Dermatitis (Reducing SCORAD Scores)

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

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.

Intervention: Dietary Intervention on Atopy (Other)

Outcomes

Primary Outcomes

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

  • Change in gut microbiota diversity and composition(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Change in skin barrier function assessed by bioengineering measures(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Change in dermatology-specific quality of life (DLQI)(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Change in atopic dermatitis-related medication utilisation(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Height and Weight Measurements(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Blood Pressure Measurement(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Blood Lipid-Lipoprotein Profile(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)
  • Change in circulating inflammatory markers (cytokines and chemokines)(Baseline, 2 months (intervention period), and 1 month post-intervention follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

CHEW Fook Tim

Associate Professor

National University of Singapore

Study Sites (1)

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