This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation.
There is an increased awareness that the bacteria which forms our microbiome, plays a crucial role in human health and diseases. Numerous studies have highlighted the therapeutic potential of specific bacteria in preventing and treating metabolic, gastrointestinal and other diseases. The aim of the study is evaluate the effect of administration of a next generation probiotic, Eubacterium hallii, versus placebo on insulin sensitivity and glycemic control, in volunteers with some markers of metabolic syndrome. Participants will receive their randomized study product daily for 12 weeks. The target population will be otherwise healthy hyperglycaemic adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Eubacterium hallii, ≥ 1x10\^9 live bacterial cells (per capsule)
Placebo capsules are identical to the active treatment
Atlantia Food Clinical Trials, Chicago
Chicago, Illinois, United States
Atlantia Food Clinical Trials
Cork, Ireland
CPS Research
Glasgow, Scotland, United Kingdom
2-hour blood glucose incremental Area Under the Curve (AUC)
as measured by standard Oral Glucose Tolerance Test (OGTT)
Time frame: From Baseline to Week 12
2-hour blood insulin incremental AUC
as measured by standard OGTT
Time frame: From Baseline to Week 12
Post-prandial insulin sensitivity
as measured by insulin sensitivity index-OGTT (ISI-OGTT)
Time frame: From Baseline to Week 12
Glycated haemoglobin (HbA1c)
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels
Time frame: From Baseline to Week 12
Glycaemic Variability (GV) over the 24-hr period
as measured by the Professional Continuous Glucose Monitoring (PCGM) device over 10as measured by the PCGM device over 10-14 days at the start and end of intervention
Time frame: From Baseline to Week 12
Glycaemic Control (GC) over the 24-hr period
as measured by the PCGM device over 10-14 days at the start and end of intervention
Time frame: From Baseline to Week 12
GV during sleeping hours
as measured by the PCGM device over 10-14 days at the start and end of intervention
Time frame: From Baseline to Week 12
Fasting Blood Glucose
Change from baseline to Week 12 in each of the treatment groups as compared to placebo in fasting blood glucose levels
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Time frame: From Baseline to Week 12
Blood Pressure
Change from baseline to Week 12 in Systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)
Time frame: From Baseline to Week 12