The study is intended to assess the effect of diet quality, food characteristics and lifestyle factors on participants’ gut microbiome as well as the effect of personalised dietitian-led nutrition coaching on diet quality
Persephone Biosciences and Kroger Health to launch AMBROSIA study. (Credit: valelopardo from Pixabay)
Biotechnology company Persephone Biosciences and Kroger Health, the healthcare division of The Kroger, has unveiled its Food as Medicine clinical study, AMBROSIA (NCT06091813).
The study is intended to assess the effect of diet quality, food characteristics and lifestyle factors on participants’ gut microbiome.
It will also evaluate how personalised dietitian-led nutrition coaching affects diet quality and satisfying the nutrition goals of every individual.
The partnership is the second collaboration between both parties.
As part of Persephone’s ongoing ARGONAUT trial, Kroger Health is identifying microbiome-based biomarkers that may be suggestive of colorectal cancer.
Under the latest initiative, the US-based firm will provide services and funds for Persephone’s AMBROSIA clinical study.
The trial aims to investigate the impact of nutrition coaching guided by a licensed dietitian and dietary supplements on gut microbiome composition, metabolic function, and food quality.
Persephone Biosciences CEO and co-founder Stephanie Culler said: “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.
“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 study is anticipated to run for 9-12 months and will recruit 400 participants. It will evaluate the impact of a Food as Medicine approach on the gut microbiome.
AMBROSIA will include four investigational cohorts, enrolled concurrently, each consisting of 100 participants.
In the study, licensed dietitians with Kroger Health will offer participants individualised nutrition coaching through Telenutrition and Kroger’s virtual dietitian service.
The study endpoints include evaluating the impact of nutrition coaching on participants’ diet quality, as well as the degree to which they accomplish their personal nutrition objectives and experience modifications in their gut microbiome composition.
Kroger Health chief commercial officer Jim Kirby said: “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 behaviour modification on the gut microbiome.”