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

A cross-over, double-blind, randomised controlled, proof of concept trial of berryfruit extract versus placebo on the FeNO level of 28 steroid naive subjects with diagnosed asthma and an FeNO of >40ppb.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000451707

Enrollment

Registered

2013-04-19

Start date

2013-06-26

Completion date

2013-09-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is being done to find out whether a New Zealand berryfruit extract is able to reduce markers of airway inflammation in people with asthma. The aim is to provide scientific evidence to support the berryfruit extract as a functional food, able to assist with human health.

Interventions

Encapsulated Berryfruit extract (1000mg), once daily, by mouth, for 28 days. Subjects will go through a washout period of 28 days between each intervention period of the study. Study extract/ placebo compliance will be captured via a capsule count, performed at the end of each intervention period (at visits 2 and 4) - study product will be collected and counted by study staff and a compliance log completed for accountability purposes.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

Outcome results