The trial will also assess the formula’s in changing serum lipid concentrations, blood pressure, fat mass, and safety.
This is the first human clinical trial conducted using the product, with subject recruitment underway from end-March.
The product trialled is Swisse Nutra+ Cholesterol Balance – a brown soft gel capsule. It is not yet launched in the market but will be made available in China first in the upcoming months, followed by Australia.
Running for four months, the trial will be conducted by Australia’s national research agency CSIRO, with the trial site in Adelaine, Kristina Gorgievska, project manager (clinical trials) told NutraIngredients-Asia.
“The hypothesis is that the formulation containing these ingredients will work synergistically to reduce LDL cholesterol,” she said.
Three out of the four bioactive ingredients used in the formulation, namely bergamot juice extract, artichoke leaf extract, and hydroxytyrosol – an antioxidant derived from olive oil, are proprietary ingredients from Italian supplier Bionap.
Gorgievska said the R&D of the formulation started in mid-2019, beginning with scientific review of the individual ingredients.
“There is a real gap in the market in terms of LDL-cholesterol lowering ingredients, there is not a lot out there.
“We know that cardiovascular disease is one of the main therapeutic areas that a lot of healthcare companies are focusing on because it is a leading cause of death globally.
“This is one of the products that have been led by our R&D solely as a passion project with minimal initial input from other teams.”
Study design
Expecting to recruit 42 participants between 18 and 65 years old, the RCT will compare the effect of Swisse Nutra+ Cholesterol Balance in reducing LDL-cholesterol with placebo.
Subjects with hypercholesterolemia, defined by having a fasting LDL-cholesterol of between 2.5 mmol/L and 5mmol/L will be recruited. Individuals with cardiovascular diseases will be excluded from the trial.
During the study, the intervention group will take three capsules of the test supplement per day – equivalent to a daily dose of 375mg of bergamot juice extract, 150mg of artichoke leaf extract, 50mg of hydroxytyrosol, and 1.8g of sunflower phytosterols.
The placebo group will take in capsules containing palm olein and olive oil.
Subjects will return to the clinic on the 2nd and 4th month of the study for assessment.
Existing evidence
While this is the first time that a human clinical trial is conducted on the formulation, Gorgievska highlighted that the individual proprietary individual ingredient has been trialled and showed effective.
For instance, the bergamot juice extract used, trademarked Bergavit 40, has shown to control plasmatic cholesterol and lipid levels.
In a study published in Frontiers in Pharmacology in 2016, the ingredient was shown to benefit cholesterol health based on a number of parameters after six months of supplementation.
During the trial, the intervention group had to take in Bergavit containing 150mg of flavonoids, which consists of 16 per cent of neoeriocitrin, 47 per cent of neohesperidin and 37 per cent of naringin daily.
By the end of the study, LDL-cholesterol level dropped significantly from 4.6 ± 0.2 to 3.7 ± 1.0 mmol/l, with a p-value of less than 0.0001.
On the other hand, “good cholesterol” HDL-cholesterol also increased significantly from 1.3 ± 0.2 to 1.4 ± 0.4 mmol/l, with p-value of less than 0.0007.
The researchers said the improvement in cholesterol health was due to the high amounts of flavonoids.
On the other hand, the artichoke leaf extract, trademarked Altilix, have shown to improve hepatic and cardiometabolic parameters in a six-month RCT.