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Clinical Trials/NCT05400525
NCT05400525
Completed
Not Applicable

University of Roehampton

University of Roehampton1 site in 1 country30 target enrollmentJune 15, 2022
ConditionsPre-diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-diabetes
Sponsor
University of Roehampton
Enrollment
30
Locations
1
Primary Endpoint
Changes in gut microbiota composition
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Type 2 diabetes mellitus (T2DM) is a major non-communicable disease and one of the world's fastest growing health problems. According to a 2019 report, about 463 million adults worldwide currently have diabetes and future projections indicate the number of diabetic patients will reach 700 million by 2045.1 T2DM is associated with significant morbidity, including increased risk of cardiovascular diseases (CVD) and stroke, hypertension, retinopathy and blindness, renal failure, and leg amputation. These place an enormous burden on individuals, society and the healthcare system.2

T2DM is a non-reversible but preventable condition with overweight and obesity being major risk factors. The onset of T2DM is gradual, with most individuals progressing from normoglycaemia through a pre-diabetic state. People with pre-diabetes, defined as having impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or impaired glycated haemoglobin (HbA1c),2 are at increased risk of developing T2DM and its associated complications, such as CVD and retinopathy, which can develop even in the absence of progression to overt T2DM.3-5 Pre-diabetes is a prevalent and potentially reversible condition that provides an important window of opportunity for healthcare providers to implement interventions that can delay or prevent T2DM and its complications.

A substantial body of literature has provided evidence for the role of gut microbiota in metabolic diseases including type 2 diabetes.6 Indeed, there is evidence for the effects of microbiota on glucose metabolism in both preclinical animal models of T2D and in healthy animals, by means of increasing the number of inflammatory mediators, chronic inflammation, insulin resistance and increased energy intake. Among the commonly reported findings, Bifidobacterium spp appears to be the most consistently supported by the literature genus containing microbes potentially protective against T2DM. Indeed, nearly all papers report a negative association between this genus and T2DM;7-14 while only one paper reported opposite results.15

In view of the correlation between gut microbiota, more specifically Bifidobacterium spp., and diabetes, the Bifidobacterium population and their metabolic action can be taken as an important target for interventions to prevent and/or delay the development of T2DM.

Detailed Description

Y META is a combination of gut health focused bioactives that target both the metabolic activity of existing microbiota (Bifidobacterium spp. targeting prebiotic galacto-oligosaccharides mixture) and the crosstalk of existing microbiota with host mucosal immune system through gut microbiota derived signalling molecules (Bifidobacterium derived polysaccharides commercially available as Y SKIN) that interact with the gut mucosal immune system to promote its regulatory activity and prevent accumulation of gut derived chronic inflammation, in order to revert insulin resistance, the main risk factor for the development of T2DM, without the need to modify the microbiota composition with live bacteria. In this study, we aim to explore whether a gut health focused intervention, in the form of Y META, affect blood glucose level and risk factors for diabetes in pre-diabetic subjects via modification of insulin sensitivity and other post-interventional effects.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
September 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
University of Roehampton
Responsible Party
Principal Investigator
Principal Investigator

DR ADELE COSTABILE

READER IN NUTRITION

University of Roehampton

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in gut microbiota composition

Time Frame: Changes from baseline to 6 and 12 weeks of the intervention

To investigate the effect of Y META intervention on gut microbiota composition

Changes in immune response

Time Frame: Changes from baseline to 6 and 12 weeks of the intervention

To investigate the effect of Y META intervention on immune function in pre-diabetics

Changes in insulin sensitivity

Time Frame: Changes from baseline to 6 and 12 weeks of the intervention

To investigate the mediating effect of Y META on insulin sensitivity in pre-diabetics

Changes in blood glucose levels

Time Frame: Changes from baseline to 6 and 12 weeks of the intervention

To investigate the effects of Y Meta intervention on blood glucose levels of pre-diabetics

Secondary Outcomes

  • Dietary Habits(Changes from baseline to 6 and 12 weeks of the intervention)

Study Sites (1)

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