Double Blinded, Randomized, Placebo-controlled Parallel Investigation Into the Effects of Supplementing Y META, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population (YMETA)
Primary Purpose
Pre-diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
YMETA
Placebo control
Sponsored by
About this trial
This is an interventional treatment trial for Pre-diabetes
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Sites / Locations
- Health Sciences Research Centre, Life Sciences Department, University of RoehamptonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
YMETA
Maltodextrin
Arm 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)
Outcomes
Primary Outcome Measures
Changes in blood glucose levels
To investigate the effects of Y Meta intervention on blood glucose levels of pre-diabetics
Changes in insulin sensitivity
To investigate the mediating effect of Y META on insulin sensitivity in pre-diabetics
Changes in gut microbiota composition
To investigate the effect of Y META intervention on gut microbiota composition
Changes in immune response
To investigate the effect of Y META intervention on immune function in pre-diabetics
Secondary Outcome Measures
Dietary Habits
To investigate the effect of Y META intervention on dietary habits
Full Information
NCT ID
NCT05400525
First Posted
May 27, 2022
Last Updated
September 5, 2022
Sponsor
University of Roehampton
Collaborators
Vemico Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05400525
Brief Title
Double Blinded, Randomized, Placebo-controlled Parallel Investigation Into the Effects of Supplementing Y META, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population
Acronym
YMETA
Official Title
University of Roehampton
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roehampton
Collaborators
Vemico Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
YMETA
Arm Type
Active Comparator
Arm 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)
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
YMETA
Intervention Description
1 sachet containg a total of 3g i.e. 2.5g Galacto-oligosaccharides, 0.5g Bifidobacterium polysaccharides (daily)
Intervention Type
Other
Intervention Name(s)
Placebo control
Intervention Description
3g Maltodextrin (i.e. DE 10) daily
Primary Outcome Measure Information:
Title
Changes in blood glucose levels
Description
To investigate the effects of Y Meta intervention on blood glucose levels of pre-diabetics
Time Frame
Changes from baseline to 6 and 12 weeks of the intervention
Title
Changes in insulin sensitivity
Description
To investigate the mediating effect of Y META on insulin sensitivity in pre-diabetics
Time Frame
Changes from baseline to 6 and 12 weeks of the intervention
Title
Changes in gut microbiota composition
Description
To investigate the effect of Y META intervention on gut microbiota composition
Time Frame
Changes from baseline to 6 and 12 weeks of the intervention
Title
Changes in immune response
Description
To investigate the effect of Y META intervention on immune function in pre-diabetics
Time Frame
Changes from baseline to 6 and 12 weeks of the intervention
Secondary Outcome Measure Information:
Title
Dietary Habits
Description
To investigate the effect of Y META intervention on dietary habits
Time Frame
Changes from baseline to 6 and 12 weeks of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
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.
Exclusion criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ADELE COSTABILE
Phone
02083923571
Email
adele.costabile@roehampton.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADELE COSTABILE, DR
Organizational Affiliation
University of Roehampton
Official's Role
Study Director
Facility Information:
Facility Name
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
City
London
State/Province
UK
ZIP/Postal Code
SW15 4JD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adele Costabile
12. IPD Sharing Statement
Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://discoverthesecretofgoodhealth.weebly.com
Learn more about this trial
Double Blinded, Randomized, Placebo-controlled Parallel Investigation Into the Effects of Supplementing Y META, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population
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