Royal DSM, a global, purpose-led, science-based company, partnered with Atlantia Clinical Trials Ltd., a world leading contract research organisation to explore the potential benefits of DSM’s Fruitflow® on gut microbiota and cardiovascular health through the gut-heart axis. The results of the clinical trial, found that four weeks of supplementation with Fruitflow®, a water-soluble tomato concentrate, decreases fasting blood and urine trimethylamine N-oxide (TMAO) levels. Higher levels of TMAO have been linked to adverse cardiovascular events. This new study supports DSM’s redefined health benefit platform for the dietary supplement industry – Health from the Gut. This new platform demonstrates DSM’s capabilities as an end-to-end purpose-led partner with an innovative range of solutions that enhance gut health to support immunity, digestion, brain health, stress management, metabolic health and more.
The gut-heart axis
Research suggests that the gut microbiome could have a powerful effect on a range of health conditions. This idea is going mainstream with 56% of global consumers stating they worry about digestive health. Fruitflow® is already well-known for its cardiovascular benefits, but it is also rich in secondary metabolites that were hypothesized to modulate the gut microbiota. These plant polyphenols are prebiotic candidates that are largely unable to be absorbed in the small intestine but reach the colon, where they undergo extensive biotransformation by the gut microbiota. As TMAO is dependent on metabolism by the intestinal microbiota, gut microbiome strategies have emerged for the prevention of cardiovascular disease.
TMAO is created when TMA is absorbed by the intestinal epithelium and transported to the liver. TMA is a microbial metabolite produced by the gut microbiome from dietary phosphatidylcholine and L-carnitine, commonly found in red meat, cheese and eggs and previously thought to be a waste product of choline metabolism. TMAO is an emerging biomarker known for its proatherogenic effects and lipopolysaccharides (LPS), a marker of intestinal permeability and low-grade inflammation. Therefore, a changed gut microbiota and increased intestinal permeability may be the causes of chronic inflammation, which worsens cardiac function. 
About this study
The research team was led by Dr. Steinert, Principal Scientist at DSM and lecturer at Zurich University. Analysis of the clinical outcomes was carried out by Gillian Dunngalvin at Atlantia. The study was a randomized double-blind, placebo-controlled crossover study carried out over 14 weeks among 40 healthy, overweight and obese adults aged 35-65 years. In addition to biological samples, questionnaires such a Gastrointestinal Symptom Rating Scale (GSRS), Bristol Stool Chart and a Food Frequency Questionnaire (FFQ) were completed by the participants.
Fruitflow® significantly decreased fasting blood and urine TMAO levels when compared to baselines. Plasma LPS levels also decreased, this is a gut microbiota-derived factor that has been linked to chronic inflammation-related diseases such as obesity, type 2 diabetes or non-alcoholic fatty liver disease (NAFLD).
A clear distinction was observed between plasma samples when applying untargeted metabolomics, with TMAO being the top-ranking feature driving the differences found across the participants consuming Fruitflow® compared to the control group. The microbiome composition and microbial beta diversity changed significantly with consumption of Fruitflow®. Lower levels of Bacteroides, Ruminococccus and Hungatella were found, which are known for their involvement in TMA and TMAO metabolism.
The findings of this study are in line with earlier studies suggesting reproducible effects with polyphenol-rich extracts.
This study shows that natural extracts rich in polyphenols can lower a person’s TMAO levels and therefore suggests novel therapeutic approaches can be explored for patients with cardiovascular conditions. This could open the door to developing novel dietary solutions with cardiometabolic benefits through the gut-heart axis and potentially mental wellbeing benefits through the gut-brain axis.
This trial asserts that polyphenol-rich extracts can modulate the gut microbiota conferring a host health benefit, more research is needed to explore potential benefits in inflammation and age‐related cognitive dysfunction.
Dr. Robert E. Steinert, Principal Scientist at DSM comments:
DSM is committed to helping people improve their gut health and use this as a gateway to overall wellbeing. The results of this study are incredibly encouraging and support earlier findings that polyphenol-rich extracts can lower TMAO concentrations through a targeted and beneficial modulation of the gut microbiota. We’re looking forward to working with our customers to develop new dietary supplement solutions targeting the gut-heart axis. Looking ahead, this study paves the way for future research into the gut-brain axis, especially age-related cognitive decline. This is an exciting time for gut-health research.
Atlantia Clinical Trials Ltd.
Atlantia Clinical trials is a world class provider of human clinical studies. For over a decade Atlantia has delivered clinical results to our many clients around the world, on time and on budget. Atlantia strives to offer the highest quality science while maintaining a cost-conscious approach to maximise the value proposition for each sponsor.
Atlantia’s state-of-the-art clinic sites both in Ireland and the USA ensure Atlantia can offer multicentre multinational studies of all design types, across a broad and diverse array of health areas and product portfolios. Atlantia’s highly qualified and dedicated team will help you manage all aspects of your clinical project and guide you through the entire process, while keeping you fully informed of progress. As Atlantia own and operate their own clinics all of their ICH-GCP certified team are on hand to ensure clinical data is of the very highest quality and integrity and in strict accordance with the protocol. More information can be found at www.atlantiaclinicaltrials.com
 Fruitflow® is a trademark of Provexis plc.
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