This is the first time that the product is used in a trial by the research institute. The product has already been used in other human trials, such as on sarcoidosis patients.
In this double blind, placebo-controlled crossover study, healthy subjects will first take a 30ml shot of BerriQi for a week before being exposed to an ozone pollution meant for inducing lung inflammation, lead researcher Dr Odette Shaw told NutraIngredients-Asia.
The exposure is to simulate the effects of industrial pollution on the lungs. It will take place at the Global Energetics and Environmental Simulation Suite housed within University of Otago’s Centre for Translational Physiology.
While exposure to ozone could cause acute lung inflammation, Dr Shaw said the effects would dissipate once the ozone was removed and would not cause long term damage.
Following the exposure, the subjects will then continue to take BerriQi for another week.
After which, there will be a one-month washout period and then, the subjects will take part in the second leg of the study, this time round taking the placebo, a BerriQi shot with no bioactives.
About 80 individuals from New Zealand will be recruited for this study. Those with prior respiratory or cardiovascular diseases will be excluded from the study.
“Through the evaluation of a range of fruits in a number of pre-clinical models, we have identified that the BerriQi® combination of Boysenberry and apple can help reduce inflammation in the airways, support tissue repair and reduce lung fibrosis.
“This research will allow us to run clinical trials to determine whether this effect is seen in humans,” says Dr Shaw.
The primary outcome is to measure the change in fractional exhaled nitric oxide (FeNO).
The secondary outcomes measured include 1) lung health symptom scores as recorded by the subjects in their daily diary, 2) blood-circulating immune cell and cytokine biomarkers of immune system activation, 3) blood analysis for bioavailability of phytochemicals and identification of potentially active metabolites, and 4) spirometry.
The trial will also study the possible mechanisms behind any effects seen.
Preclinical in vitro and in vivo research have shown that BerriQi could reduce scar tissue deposits – a result of the body fighting against inflammation – on the lungs.
Funded through the High-Value Nutrition (HVN) National Science Challenge, this clinical trial is expected to take place late next year or in early 2022.
“As the respiratory immune system can protect the body against damage caused by inhalation of particulate matter, the identification of food solutions that offer respiratory immune support is a key target of High-Value Nutrition’s Immune Health Research Programme,” says Joanne Todd, HVN Director.