Clinical trial affirms ketogenic ingredient induces and sustains ketosis

Published: 30-Jun-2023

Avela has a clinically demonstrated ability to provide sustained energy in the form of D-BHB ketone, an alternative energy source to glucose in humans

Geno has announced the results of a new clinical trial exploring the effects of its exogenous ketone, Avela, when consumed in beverage form.

The study, published in the peer-reviewed journal, Frontiers in Physiology, assessed BHB levels and tolerability in human subjects following consumption of Avela. Elevated BHB levels in the human body have been scientifically reported as providing benefits of increased energy, mental clarity and support for improved athletic endurance. 

The study results provide further support that Avela is effective at raising BHB levels and generating on-demand ketosis within 30 minutes of ingestion. The ingredient induced and maintained ketosis for up to five hours when administered orally in a three-dose process. The study group of 26 people achieved peak BHB blood levels of 2.1 +/- 0.97 mmol/L one hour after consuming Avela and reported no significant side effects or adverse events. 

Avela has a clinically demonstrated ability to provide sustained energy in the form of D-BHB ketone, an alternative energy source to glucose in humans. When (R)-1,3-Butanediol is ingested, it directly converts to D-BHB, the primary form humans can readily use for energy. After the final dose of Avela was administered, the cohort remained in ketosis for four hours, demonstrating a sustained elevation of BHB as an energy source.

As secondary objectives, gastrointestinal (GI) symptomology, sleepiness and other symptoms were assessed throughout the study. Overall, Avela was well tolerated, with no or mild GI symptoms reported by most participants, and no effect on subject sleepiness was reported.

The clinical trial demonstrates the value of Avela as an effective method for raising BHB levels in humans to achieve nutritional ketosis. Geno launched Avela in the US in November 2022 as an ingredient for functional foods and beverages, especially in the keto, energy, and fitness and wellness categories, offering consumers an accessible alternative to fasting or restrictive dieting to achieve sustained ketosis. 

The study was published in the multidisciplinary, open-access journal Frontiers in Physiology, “An Open-label, Acute Clinical Trial in Adults to Assess Ketone Production, Gastrointestinal Tolerability, and Sleepiness Following Consumption of (R)-1,3-Butanediol (Avela™).” A comprehensive article featuring the complete study can be found here.

James Lowder, MD, Hematologist Oncologist, Study Principal Investigator, said: “In this study, Avela demonstrated good tolerability when taken in accordance with GRAS guidelines. The results tell us we can consider (R)-1,3-Butanediol effective at producing blood ketone levels comparable to those achieved through the diet alone.                                        

Brianna Stubbs, DPhil, Lead Translational Scientist for The Buck Institute for Research on Ageing, said: "Over the last ten years, scientists and consumers have realised that ketones are more than an emergency backup fuel. They are discovering the different effects ketones can have within the body. This is an energising, exciting moment and a step forward for the industry.”

Avela has been concluded to be generally recognised as safe by a panel of independent, qualified scientists for use by the general population as a source of energy in beverages, bars and gels.

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