Supplementation of YMETA, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population

NCT05400525 | Completed DMC

• 1 other identifier: LSC 22/374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (4)

• Changes in blood glucose levels

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

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in insulin sensitivity

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

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in gut microbiota composition

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

  Changes from baseline to 6 and 12 weeks of the intervention

• Changes in immune response

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

  Changes from baseline to 6 and 12 weeks of the intervention

Secondary Outcomes (1)

• Dietary Habits

  Changes from baseline to 6 and 12 weeks of the intervention

Study Arms (2)

YMETA

ACTIVE COMPARATOR

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)

Dietary Supplement: YMETA

Maltodextrin

PLACEBO COMPARATOR

Other: Placebo control

Interventions

YMETA DIETARY_SUPPLEMENT

1 sachet containg a total of 3g i.e. 2.5g Galacto-oligosaccharides, 0.5g Bifidobacterium polysaccharides (daily)

YMETA

Placebo control OTHER

3g Maltodextrin (i.e. DE 10) daily

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged between 18 and 60 years, with
• Fasting blood glucose level of 5.6-6.9mmol/L or
• Impaired HbA1c (HbA1c level of 5.7%-6.4%)
• For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.

You may not qualify if:

• People with a current diagnosis or clinical history of T2DM
• People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
• People who are already participating in a weight loss programme
• People receiving drug treatment for pre-diabetes (eg, metformin)
• People with a history of long-term use of medicines known to influence glucose metabolism (eg, corticosteroids)
• People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
• People who take antibiotics or bacterial agents (Probiotics) within 1 month
• Pregnant women, women ready for pregnancy, and nursing mothers

Sponsors & Collaborators

• University of Roehampton: lead
• Vemico Ltd.: collaborator

Study Sites (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• ADELE COSTABILE, DR

  University of Roehampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: READER IN NUTRITION

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: June 15, 2022
• Primary Completion: June 10, 2023
• Study Completion: September 20, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)