The effect of berryfruit extract on airways inflammation and airways obstruction in asthma

Phase 1

Completed

• Conditions: Asthma; Respiratory - Asthma; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12613000451707
• Lead Sponsor: The New Zealand Institute for Plant & Food Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Doctor diagnosis of asthma
Steroid naive (no inhaled or oral corticosteroid in the last 90 days)
Exhaled FeNO of >40ppb
Aged 18-75

Exclusion Criteria

Unable to provide informed consent
Unable or unwilling to comply with study procedures, including not consuming confounding foodstuffs during study periods
Known hypersensitivity to berryfruit polyphenolic compounds Known pregnancy
Any other safety concern at the investigator’s discretion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractional exhaled Nitric Oxide (FeNO) level<br>FeNO will be measured as per the ATS guidelines (2005), via either chemoluminescence using an online nitric oxide monitor (NIOX; Aerocrine AB, Solna, Sweden), or a NIOX MINO device.[Measured at Baseline, 4 weeks, 8 weeks, 12 weeks]

Secondary Outcome Measures

Name	Time	Method
Spirometry (FEV1)<br>FEV1 measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.[Measured at baseline, 4 weeks, 8 weeks, 12 weeks];Resistance/Conductance (sRaw / sGaw)<br>sRAW/ sGAW measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.[Measured at baseline, 4 weeks, 8 weeks, 12 weeks];Small airways function (MMEF 25-75)<br>MMEF 25-75 measured in a body plethysmograph (Masterscope, Jaeger), according to ATS guidelines.[Measured at baseline, 4 weeks, 8 weeks, 12 weeks];Peripheral blood eosinophil count[Measured at baseline, 4 weeks, 8 weeks, 12 weeks];Shortened Asthma Control Questionnaire (ACQ-5)[Measured at Baseline, 4 weeks, 8 weeks, 12 weeks];Reliever use (captured from question 6 of ACQ) [Measured at baseline, 4 weeks, 8 weeks, 12 weeks]