PRIME Study
Research type
Research Study
Full title
PRebiotic Intervention for Metabolic health (PRIME): Assessing the Effects of a Daily Prebiotic Fibre Blend on Inflammation, the Gut Microbiome, and Self-Report Measures of Mental Health in Individuals with Metabolic Syndrome
IRAS ID
329618
Contact name
Caitlin Hall
Contact email
Sponsor organisation
Myota
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
In the UK, it’s estimated that 1 in 3 adults aged 50 years or over meets the criteria for metabolic syndrome (NHS, 2023). Emerging evidence suggests that metabolic syndrome is associated with low-grade systemic inflammation, which is thought to play a critical role in the pathogenesis of various metabolic and cardiovascular diseases. In fact, the inflammatory biomarker, high-sensitivity (hs)-CRP, has been shown to be predictive of the progression of metabolic syndrome and subsequent risk of cardiovascular disease (CVD), type 2 diabetes (T2D), and cancer mortality (Li et. al, 2017; Haffner, 2006). Alongside metabolic disturbances, recent studies have shown that repeated (or long-term) exposure to systemic inflammation is also associated with an increased risk of future depressive and anxiety symptoms (Bell et. al, 2017), potentially acting via the blood-brain barrier (BBB) interface.
From both a physical and mental health standpoint, it’s clear that novel interventions, beyond pharmacotherapy, are needed to reverse the progression of metabolic syndrome, and reduce the risk of developing a long-term chronic disease and poor mental health.
It is well established that dietary fibre plays a critical role in reducing symptoms of metabolic syndrome, including improvements in insulin sensitivity, glucose metabolism, lipid profile, and blood pressure (Anderson et al., 1984; Jenkins et al., 2002; Jenkins at al., 2005; Levitan et al., 2009; Reynolds et al., 2020; Teff et al., 2009).
In this current study, we aim to assess the effects of a daily prebiotic fibre blend on systemic inflammation, the gut microbiome, lipid profiles, and self-report measures of mental health in individuals with metabolic syndrome. The study will be conducted over 12 weeks, and the findings may provide new insights into the potential role of prebiotics in the prevention and management of physical and mental health risk factors associated with chronic disease.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0515
Date of REC Opinion
19 Jun 2023
REC opinion
Further Information Favourable Opinion