Clinical trial NCT06547372: Dietary Intervention on Atopy
Official title: Dietary Intervention on Atopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Atopic
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dietary habits play an indispensable role in maintaining overall health and well-being. In recent years, emerging research has underscored the importance of dietary factors on a range of diseases which include allergic (atopic) diseases such as atopic dermatitis (AD). Conducting a dietary intervention study related to AD can provide valuable insights into the relationship between diet and the development or management of this particular allergic skin condition.

Detailed description: Atopic dermatitis (AD) is a chronic inflammatory skin disease highly associated with xerosis and pruritus, affecting a substantial portion of individuals of all age groups. The European Academy of Allergy and Clinical Immunology (EAACI) Task Force on Diet and Immunomodulation also emphasized the role of dietary patterns as an important indicator to study the risk of allergic diseases. Furthermore, emerging epidemiological findings and randomised controlled trials (RCT) in recent decades strongly suggest that diet may play a pivotal role in not only triggering and exacerbating AD but also in its effective management.

Preliminary cross-sectional findings in a large independent allergic cohort of 13,561 young Chinese Adults from Singapore and Malaysia highlighted that a frequent intake of high-fat foods such as margarine, butter, seafood, and burgers and fast foods is strongly associated with a higher risk of AD. A diet consisting mainly of high-fat foods, or a high-fat diet as shown by a derived amount- and score-based dietary indices was strongly associated with a higher risk for severe AD even controlling for potential confounding factors like age, sex, body mass index (BMI), lifestyle habits, and genetic predisposition. On the other hand, a frequent adherence to a plant-based food dietary pattern consisting of fruit, vegetables, and cereals was associated with a lowered risk of severe AD. Overall, these compelling findings aligned with evidence-based guidelines such as "My Healthy Eating Plate, Singapore", a visual guide designed to promote a balanced and nutritious dietary pattern specific to the Singaporean context.

In conclusion, a whole diet dietary intervention on AD that adhere to established dietary recommendations such as "My Healthy Eating Plate, Singapore", may offer a promising avenue for individuals seeking to i) improve AD symptoms, ii) improve skin health, and iii) improve quality-of-life.

Eligibility criteria: Inclusion Criteria:

1. Presence of current, mild-to-moderate atopic dermatitis/eczema at flexural areas
2. 21 to 65 years of age (inclusive) at screening
3. Must be English-literate and able to give informed consent in English
4. Be residing in Singapore and will not be travelling outside of Singapore during the study period
5. Reliable and willing to follow study procedures and be available for the duration of the study
6. Non-smokers (tobacco and e-cigarette)
7. Non-drinker (no regular or frequent consumption of alcohol)
8. Overtly healthy with no pre-existing medical conditions (e.g., diabetes, hypertension, cancer, blood disorders, degenerative/liver/autoimmune/immune/renal diseases, or psychiatric conditions)
9. No food allergies to test foods
10. No needle phobia
11. Be willing to not apply any moisturiser, cosmetics, and/or topical cream on the skin throughout the entire duration of the study.

Exclusion Criteria:

1. Concurrent participation in other research studies
2. Pregnancy or lactating individuals
3. Known or ongoing psychiatric disorders within 3 years
4. Known severe nutritional deficiency
5. Vegetarian/vegans (as meat will be included in the diet)
6. Individuals who made a significant dietary change in the past 12 months
7. Having a pre-existing dietary restriction that would interfere with the adherence to a whole diet meal
8. Regular use of strong medication (western and/or traditional), therapies, and alternative medications
9. Regular nutritional supplements in the past 12 months Regular consumption of oral contraceptive pills and/or steroid hormones
10. Antibiotic use in the past 2 months
11. Any long-term hospitalisation or surgery during the 6 months before enrolment in study
12. Significant change in weight (+/- 5.0%) during the past month
13. History of bleeding diathesis or coagulopathy (or any bleeding disorders)
14. Having donated blood of more than 500 mL within 4 weeks of study enrolment

Primary outcomes:
measure: Reduction of SCORAD Scores by a Healthy Dietary Pattern
timeFrame: 3 months
Secondary outcomes:
measure: To determine the impact of an improved dietary pattern on the quality of life of participants with AD, using the Dermatology Life Quality Index (DLQI) in reducing the severity of AD in Singapore adults
timeFrame: 3 months
measure: Number of participants with improved skin barrier functions as assessed by skin hydration, transpidermal water loss, pH, and sebum level
timeFrame: 3 months
measure: Number of participants with changes in immune functions as assessed by blood cytokine and chemokine levels.
timeFrame: 3 months
measure: Number of participants with changes in gene expression profile as assessed by the changes in differentially expressed genes (DEGs).
timeFrame: 3 months
measure: Number of participants with changes in gut microbiota profile as assessed by the changes in gut microbiota diversity and composition.
timeFrame: 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: NUS Singapore
name: Fook Tim CHEW, PhD
role: PRINCIPAL_INVESTIGATOR
References: