Status:
COMPLETED
Supplementation of YMETA, on Gut Health, Immunity and Metabolism in Pre-diabetic Adult Population
Lead Sponsor:
University of Roehampton
Collaborating Sponsors:
Vemico Ltd.
Conditions:
Pre-diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
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 hav...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05400525
Start Date
June 15 2022
End Date
September 20 2023
Last Update
November 15 2023
Active Locations (1)
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1
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom, SW15 4JD