Effectiveness of Lycopene-rich diet on childhood asthma outcomes

Phase 3

Completed

• Conditions: Childhood asthma; Childhood Asthma, Clinical Outcomes, Effectiveness, Lycopene-rich diet, Pulmonary Function Test

• Registration Number: TCTR20230308001
• Lead Sponsor: The Thai Medical Council

Brief Summary

Eighty participants completed the study. Compared with the control group, the experimental group showed significant improvement in ACT different score (1.083 v.-0.786; p-value, 0.005) and PAQLQ total different score (2.208 v. -4.250; p-value, 0.002). However, ICS dose usage, PFT, and serum antioxidant levels did not show significant difference between the 8-week period of study. Good compliance and less side effects regarding the fruit juice consumption were observed among participants.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-11
• Study Start: 2023-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria were comprised of; asthmatic children aged 4-15 years who were physician diagnosed, mildly or moderately persistent asthma following the Global Initiative for Asthma guidelines [37], 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

Exclusion criteria were consisted of; 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 [38], 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
asthma control, quality of life , PFT 8-week apart ACT, PAQLQ questionnaires, SPIROMETRY

Secondary Outcome Measures

Name	Time	Method
ICS dose, serum antioxidant levels at initial and 8-week apart questionnaire, blood levels