The effect of BerriQi® Boysenberry and apple product on lung function following ozone exposure

Not Applicable

• Conditions: reduced lung function; lung inflammation; Respiratory - Other respiratory disorders / diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12621000774820
• Lead Sponsor: The New Zealand Institute for Plant and Food Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-21
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Healthy male and female (50/50) non-pregnant individuals 18-40 years of age with normal lung function at baseline will be selected

Exclusion Criteria

•If they are unwilling or unable to provide informed written consent or comply with the study procedures.
•If they have known hypersensitivity or intolerance to Boysenberry or apple-derived products and/or specific food additives.
•If they have a diagnosed health conditions that impair their lung function (asthma, COPD, fibrosis), diabetes or cardiovascular disease.
•If they smoke.
If they have a job where they have high occupational exposure to respiratory irritants such as ozone or particulate matter (eg welder)
In addition, participants will also be excluded if they have the following health conditions: (i) blood borne diseases (e.g. hepatitis), (ii) clinically diagnosed high/low blood pressure, (iii) recent bacterial or viral illness or (iv) are taking medication that affects the properties of blood (e.g. blood clotting)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exhaled nitric oxide (FeNO) will be measured using an exhaled nitric oxide detector that participants breath into to measure nitric oxide in their breath. Nitric oxide is a gas produced by cells involved in inflammation and an increase of 10% (10ppb) from baseline is considered to be a clinically relevant indicator of lung inflammation.[Baseline, immediately post (0h) and 2 (primary timepoint), 24h and 48h post ozone exposure];Forced expiratory volume in 1 minute (FEV1) and forced vital capacity (FVC) will be measured using a clinical spirometer to assess these clinically relevant parameters of participant’s lung function.[Baseline, immediately post (0h) and 2 (primary timepoint),, 24h and 48h post ozone exposure]