Pre-diabetesYMETANCT05400525
Supplementation of YMETA, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population
A study testing YMETA in people with Pre-diabetes, run by University of Roehampton at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- YMETA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
Official title: University of Roehampton
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.
Read more
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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- YMETA, Placebo control
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMETADietary supplement
1 sachet containg a total of 3g i.e. 2.5g Galacto-oligosaccharides, 0.5g Bifidobacterium polysaccharides (daily)
Placebo controlOther
3g Maltodextrin (i.e. DE 10) daily
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: YMETA |
| Maltodextrin | Placebo comparator | Not described Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood glucose levels
To investigate the effects of Y Meta intervention on blood glucose levels of pre-diabetics
Measured: 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
Measured: 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
Measured: 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
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Secondary outcomes (1)
Dietary Habits
To investigate the effect of Y META intervention on dietary habits
Measured: Changes from baseline to 6 and 12 weeks of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start15 Jun 2022
- Primary completion10 Jun 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- Vemico Ltd.
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, DR, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400525
- Sponsor's protocol ID
- LSC 22/374
- Acronym
- YMETA
- Status last verified
- Nov 2023
- First submitted
- 27 May 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Roehampton
- ClinicalTrials.gov ID
- NCT05400525
- Acronym / sponsor ID
- YMETA / LSC 22/374
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- Vemico Ltd.
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YMETA | Active comparator | Dietary Supplement: YMETAY 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) |
| Maltodextrin | Placebo comparator | Other: Placebo control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YMETA1 sachet containg a total of 3g i.e. 2.5g Galacto-oligosaccharides, 0.5g Bifidobacterium polysaccharides (daily) | Dietary supplement | YMETA |
| Placebo control3g Maltodextrin (i.e. DE 10) daily | Other | Maltodextrin |
Primary outcome
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
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 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
1 secondary outcome
Dietary Habits
Time frame: Changes from baseline to 6 and 12 weeks of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADELE COSTABILE, DR study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YMETA in people with Pre-diabetes, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood glucose levels (time frame: Changes from baseline to 6 and 12 weeks of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.