New research commissioned by Supergut examined the effects of a prebiotic fiber-enriched nutritional formula on quality of life and metabolic control in type 2 diabetes. The study was recently published in the peer-reviewed medical journal Diabetes, Obesity and Metabolism.
The 12-week, double-blind, placebo-controlled study included an unblinded dietary advice only comparator arm. Overall, 192 participants were randomized into three groups. The groups included 95 in the prebiotic fiber-enriched nutritional formula (Active) group, 48 in a placebo fiber-absent nutritional formula (Placebo) group and 49 in the non-blinded dietary advice alone (Diet) group. The primary endpoint was a change in core Type 2 Diabetes Distress Assessment System (cT2-DDAS) at week 12. Glycated hemoglobin (HbA1c) change was a key secondary endpoint.
The study was decentralized, leveraging a virtual team who virtually coordinated research efforts. According to Supergut, this allowed more diverse subjects to be recruited quickly and a strong representation from typically underrepresented minority populations. From start to end, the study took just under a year and included ethnic and racial diversity not often seen in similar studies. Notably, almost 20% of participants were Black.
“On the flip side, there were the challenges of coordinating a very complex study with multiple surveys and bio specimen collections. Working with groups like Citruslabs, the study's contract research organization and PhlebFinders, the studies mobile phlebotomy service, are what made such a study possible,” explained Marc Washington, founder and CEO, Supergut.
The researchers concluded that the microbiome-targeting nutritional formula significantly improved endpoints, suggesting the potential for prebiotic fiber as a complement to lifestyle and/or intervention for managing type 2 diabetes.
“Supergut shakes are effective at improving quality of life and lowering hemoglobin A1C, relative to placebo. We saw a comparable reduction in hemoglobin A1C from our meal replacement shakes formulated with a resistant starch fiber blend as first-line oral medications for diabetes, but without GI side effects. We also saw improvements to a GI score that included both upper (heartburn, nausea) and lower (bowel movements and bloating) GI symptoms as compared to the diet-alone arm” explained Washington.
"Additionally, weight, blood pressure, and a non-diabetes related quality of life measure that included sleep, mental clarity, and mood were significantly improved. These effects may have resulted in part from changes in the microbiome. There was an observed increase in butyrate-producing bacterial species in the gut. Butyrate is known to stimulate the release of GLP-1 from the cells lining the lower GI Tract. This is the natural gut-derived analogue of the synthetic GLP-1 therapies (e.g., Wegovy, Ozempic) that have received much press recently for being effective not only in blood sugar control, but also weight loss,” he added.
Washington said the study is a significant milestone in the company’s history–and hopefully for the broader functional food space–by adding to the evidence of several pilot studies that had previously demonstrated the blood sugar stabilizing effects of the Supergut’s fiber blend.
“These findings enable us to emphatically answer ‘yes’ to the most common question consumers are increasingly asking about their functional health products…’Does it work?’ We can do so with rigorous scientific-credibility and clinically-validated evidence.”
At the end of the day, the company hopes this work shines a light on metabolic health and ushers in a new era for functional foods backed by rigorous clinical evidence.
“It is our thesis that the growing public health crisis of diabetes and obesity can in part be ameliorated through thoughtful next-generation approaches to food that embrace the functional properties of bioactives, including prebiotic fibers like resistant starch,” Washington said.
Looking ahead, Supergut plans to pursue opportunities related to gut-brain connections seen in sleep, mental clarity and mood.
Source: Diabetes, Obesity and Metabolism
03 January 2023 https://doi.org/10.1111/dom.14967
“A microbiome-targeting fibre-enriched nutritional formula is well tolerated and improves quality of life and haemoglobin A1c in type 2 diabetes: A double-blind, randomized, placebo-controlled trial”
Authors: J. P. Frias et al.
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