Effectiveness of Lycopene-rich diet on childhood asthma outcomes

Phase 2

Completed

• Conditions: Mild to moderate asthmatic children treated at two primary care settings; Childhood Asthma, Clinical Outcomes, Effectiveness, Lycopene-rich diet, Pulmonary Function Test

• Registration Number: TCTR20230529001
• Lead Sponsor: Thai Medical Council

Brief Summary

Evidences showed significant improving on ACT, total PAQLQ and subdomains scores. Half of participants showed favorable on palatability of a product. Nevertheless, ICS dose usage, pulmonary function tests and serum antioxidant levels (lycopene, beta-carotene and ascorbic acid) were not affected by the intervention. In addition, fruit, vegetable and juice consumption habit along with baseline serum antioxidants were similar between well controlled and partly or uncontrolled asthmatic children.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-11
• Study Start: 2023-05-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

asthmatic children aged 4-15 years who were physician diagnosed, mildly or moderately persistent asthma following the Global Initiative for Asthma guidelines , previously treated and ICS prescribed within 24 months, comply with blood test and pulmonary function test, and completed follow-up for the 8-week period.

Exclusion Criteria

prior airway infection within 4 weeks, previous acute asthmatic exacerbation within 3 months, had chronic diseases such as cardiovascular, pulmonary, neurology, renal, or psychiatric conditions, prior consumed high dose of supplemental diet such as lycopene (60 mg/day), beta-carotene (30 mg/day) or ascorbic acid (180 mg/day) within 3 months , who denied tomato with mixed fruits juice consumption, or lost to follow-up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
asthmatic clinical control at 8 weeks after initiation of the intervention asthma control test score

Secondary Outcome Measures

Name	Time	Method
quality of life, pulmonary function, antioxidant serum level at 8 weeks after initiation of intervention Pediatric Asthma Quality of Life Questionnaire, FEV1,FEV1/FVC, FE25-75%, level of serum antioxidants