SAN DIEGO--(BUSINESS WIRE)--Persephone Biosciences Inc., a biotechnology company reimagining patient health through the development of microbiome-based medicines, today announced the launch of its Food as Medicine clinical study, AMBROSIA (NCT06091813). The study will focus on how participants’ gut microbiome is impacted by diet quality, food characteristics and lifestyle factors, as well as how personalized dietitian-led nutrition coaching impacts diet quality and meeting individual nutrition goals.
This is the second collaboration between Persephone and Kroger Health, the healthcare division of The Kroger Co. Kroger Health currently is also participating in Persephone’s ongoing ARGONAUT study (NCT04638751) to identify microbiome-based biomarkers potentially indicative of colorectal cancer. Under today’s initiative Kroger Health will contribute funding and services for Persephone’s AMBROSIA clinical study.
The role of gut microbes in human health and the impact of diet on the microbiome composition has been recognized for decades, but the specific impact of diet quality and lifestyle behaviors are only beginning to be understood. The AMBROSIA study will help determine the effect of dietary supplements and registered dietitian-led nutrition coaching on diet quality and the gut microbiome composition and metabolic function.
“We greatly value Kroger Health’s commitment to the AMBROSIA study, which we believe will break new ground in assessing the impact of nutrition coaching, as well as probiotic and prebiotic supplements, on a subject’s diet quality and microbiome composition,” said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. “Upon completion, we will have more data to assess the extent to which outcomes are determined by both diet and the human microbiome, as well as the interaction between the two, which we believe will further aid us in trying to solve growing health problems such as allergies, insufficient immunological response, and declining overall health.”
The AMBROSIA study design is expected to run for 9-12 months and will explore the impact of a Food as Medicine approach to the gut microbiome in 400 participants. It will consist of four investigational cohorts, enrolled concurrently, each consisting of 100 participants:
- Participants involved in the first cohort will receive no directed dietary modifications and will be referred to as the control group;
- Participants enrolled in the second cohort will receive registered dietitian-led virtual nutrition coaching, which will consist of one-on-one access to a Kroger Health registered dietitian;
- Participants in the third cohort will take daily probiotic and prebiotic dietary supplements;
- Participants in the fourth cohort will receive both nutrition coaching and daily probiotic and prebiotic supplements.
Kroger Health registered dietitians will provide the personalized nutrition coaching to study participants via Telenutrition, Kroger’s virtual dietitian service. Study endpoints will include evaluating diet quality changes among participants as a result of nutrition coaching, as well as meeting individual nutrition goals and changes in their gut microbiome composition.
“Kroger Health is excited to work alongside Persephone Biosciences on this innovative clinical trial,” said Jim Kirby, Chief Commercial Officer, Kroger Health. “By providing access to our one-on-one virtual nutrition coaching visits with registered dietitians, we aim to contribute valuable insights into the relationship between diet quality and behavior modification on the gut microbiome. I look forward to unlocking new avenues for personalized healthcare and improved well-being for all.”
Individuals interested in participating in the study can register their interest at ambrosiastudy.com, as well as view the full inclusion criteria.
About Persephone Biosciences
Persephone Biosciences is a biotechnology company reimagining patient health through the development of microbiome-based medicines. The company’s operations comprise Persephone Consumer Health and Persephone Therapeutics. Persephone Consumer Health is focused on adult and infant wellbeing, through the development of pioneered probiotics (My Baby Biome™ clinical study) and Food as Medicine (AMBROSIA clinical study). Persephone Therapeutics is targeting improved patient therapeutic response, with an initial focus on oncology treatment and prevention (ARGONAUT clinical study). The company was founded in 2017 by synthetic and metabolic engineers, Stephanie Culler, Ph.D., and Steve Van Dien, Ph.D. For more information, visit persephonebiosciences.com, or on Twitter and LinkedIn.