RCT of the effect of berryfruit polyphenolic cultivar extract in mild steroid-naive asthma: a cross-over, placebo-controlled study.
There is preclinical evidence that consumption of berryfruit extract may reduce chronic airways inflammation and modify airway remodelling in allergen-induced models of lung inflammation. We investigated the effect of berryfruit extract on the fractional expired nitric oxide (FeNO), a biomarker of eosinophilic airways inflammation, in adults with steroid-naïve asthma.



Randomised placebo-controlled cross-over double-blind trial.



Single-centre community-based trial.



28 steroid-naïve mild asthmatics with Feno >40 ppb, of whom 25 completed both study interventions.



Participants were randomised to receive, according to the cross-over design, 100 mg berryfruit polyphenolic extract (BFPE) or placebo for 4 weeks, with a 4-week washout period between the interventions.



The primary outcome variable was FeNO at 4 weeks, analysed by a mixed linear model, with a random effect for participant and baseline FeNo as a covariate.



The mean (SD) natural logarithm transformed (ln) FeNO after 4 weeks of treatment for the BFPE and placebo groups was 4.28 (0.47) and 4.22 (0.47), respectively. The paired change from baseline mean (SD) BFPE minus placebo ln FeNO was -0.03 (0.39), N=25. The mixed linear model estimate, with baseline covariate adjustment, difference in ln FeNO, was -0.002 (95% CI -0.15 to 0.14), p=0.98. This is equivalent to a ratio of geometric mean FeNO of 1.0 (95% CI 0.86 to 1.15).



In steroid-naïve participants with mild asthma and elevated FeNO, there was no effect of BFPE on FeNO, a biomarker of eosinophilic airways inflammation. Caution is required in the extrapolation of apparent benefit in murine models of lung eosinophilia to clinical efficacy in patients with asthma.



ANZCTR: 12613000451707; Results.
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.
Sharon
S
Power
Medical Research Institute of New Zealand, Wellington, New Zealand.
Mathew
M
Williams
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.|Victoria University of Wellington, Wellington, New Zealand.
Alex
A
Semprini
University of Otago, Wellington, New Zealand.
Claire
C
Munro
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.|Victoria University of Wellington, Wellington, New Zealand.
Rachel
R
Caswell-Smith
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.|Victoria University of Wellington, Wellington, New Zealand.
Janine
J
Pilcher
Medical Research Institute of New Zealand, Wellington, New Zealand.
Mark
M
Holliday
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.|Victoria University of Wellington, Wellington, New Zealand.
James
J
Fingleton
Malaghan Institute of Medical Research, Wellington, New Zealand.
Jacquie
J
Harper
The New Zealand Institute for Plant & Food Research, Palmerston North, New Zealand.
Roger
R
Hurst
Capital and Coast District Health Board, Wellington, New Zealand.|University of Otago, Wellington, New Zealand.
Mark
M
Weatherall
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.
Richard
R
Beasley
Medical Research Institute of New Zealand, Wellington, New Zealand.|Capital and Coast District Health Board, Wellington, New Zealand.|Victoria University of Wellington, Wellington, New Zealand.
Irene
0000-0001-5327-3027
I
Braithwaite
D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume; D005638:Fruit; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy / Q000379:methods*; D010936:Plant Extracts / Q000494:pharmacology*; D016896:Treatment Outcome; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D010936:Plant Extracts
Animal models; Clinical respiratory medicine