Approved new clinical trial with Bonolive®
Approved new clinical trial with Bonolive®
Press release
BioActor receives approval to start clinical trial with Bonolive®. BioActor’s innovative bone health ingredient Bonolive® will enter the clinic for mitigating ageing-related bone loss.
New Randomized double-blind placebo-controlled study
BioActor announced today that it has received approval from the regulatory authorities to initiate the combined Phase I/II clinical trial for its innovative bone health ingredient Bonolive®.
Bonolive®, a proprietary olive polyphenols formulation has shown strong inhibition of accelerated bone loss in an animal model for menopause and inflammation-induced bone loss. The first clinical study will be performed in Poland in collaboration with a specialized osteoporosis clinic, which has started recruiting the first subjects.
The trial is a double-blind placebo-controlled study in 60 postmenopausal women who will be treated for a duration of 12 months. The objective is to monitor tolerability, safety and biomarkers for bone metabolism as well as total bone density. BioActor’s scientific partner, INRA is actively involved in the trial design and the analysis of the results.
Hans van der Saag, Managing Director of BioActor comments: “We are very pleased with the progress that has been made with the development of Bonolive® into a first in class health ingredient addressing bone health for an ageing population.”
Osteoporosis is becoming an increasing health burden, affecting an estimated 75 million people in Europe alone. Public health authorities have recognized the need for the prevention of this chronic disease. Functional foods and dietary supplements addressing bone health are seen as excellent solutions for long-term prevention. BioActor is addressing this need by developing a unique product for bone health – Bonolive®. It is now widely known that calcium alone is not sufficient to prevent osteoporosis.
Bonolive® has already been successfully tested in an animal model for osteoporosis and targets the underlying inflammatory processes that lead to osteoporosis.
About BioActor
BioActor, based in Maastricht, Netherlands, is a product development company that has developed a range of proprietary bioactive ingredients for the nutrition & healthcare industry. The company focuses on the development of innovative activities that address active living and healthy aging. The goal is to provide the nutrition & healthcare industry with science-based innovations that confer a real health benefit to the consumer.
Feel free to contact us via info@bioactor.com for more information on the possibilities Bonolive® has to offer.
Further information can be found on: www.bonolive.com
