Clinical trial NCT04529473: Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control
Official title: A Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Markers of Glycaemic Control in Healthy Hyperglycaemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Impaired Glucose Tolerance
Insulin Sensitivity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Syndrome
Lead sponsor: Atlantia Food Clinical Trials
Sponsor class: INDUSTRY
Collaborators: name: Caelus Pharmaceuticals BV
First posted: 2020-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This 12 week placebo-controlled study evaluates the efficacy and safety of E. hallii supplementation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Give written informed consent;
* Be male and aged between 21 and 69 years, inclusive; or be female and aged between 45 and 69, inclusive
* Have a body mass index between 18.5 to 43 Kg/m2;
* Have a waist-circumference \> 94cm (37inches) for males and ≥80cm (31.5inches) for females (IDF criterion for Metabolic Syndrome);
* Have a measured Hb1Ac level of 5.5 to 8.0% (36.6 to 63.9 mmol/mol, 6.2 to 10 mmol/L) inclusive;
* If participant has a prior diagnosis of pre-diabetes or Type II diabetes who has been unmedicated for 3-months prior to screening;
* Be female and be post or peri-menopausal (female who have not had a menstrual period within the previous 9 months)
* Be willing to maintain dietary habits and physical activity levels throughout the study period;
* Be willing to consume the investigational product daily for the duration of the study;
* Capable and willing to wear the PCGM sensor
* Be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator

Exclusion Criteria:

* Morbid obesity (BMI ≥43.1);
* Prior diagnosis of Type I diabetes mellitus (i.e. a clinical diagnosis made before the screening visit of this study);
* Participants with a prior diagnosis of Type II diabetes who have received a glucose lowering medication (e.g. Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors) or insulin therapy, in the previous 3 months;
* Presence of significant dyslipidaemia (Note: ongoing treatment with stable (3-months) low-dose statins is acceptable);
* Presence of significant cardiovascular disease, including but not limited to significant systemic hypertension (SBP ≥160 mmHg and/or DBP ≥100 mmHg), pulmonary hypertension, or other unstable cardiopulmonary conditions, limiting or unstable angina, congestive heart failure. (Note: ongoing treatment with stable (3 months) antihypertensives is acceptable);
* Present or recent (within 2 months of screening) use of dietary supplements intended to affect the level of blood glucose. The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed, if stable (3-months);
* Participant regularly takes probiotic supplements, or has done within the 4-weeks prior to screening or plans to during the study;
* Participant has taken oral antibiotics, antifungal, antiparasitic, or antiviral treatment in the 4-weeks prior to screening (topical permissible);
* Participant has a history of co-existing gastrointestinal, and/or gynaecological, and/or urologic pathology (e.g. colon cancer, colitis, Crohn's Disease, Celiac, Endometriosis, prostate cancer);
* Presence or history of significant and diagnosed gastrointestinal diseases that, in the opinion of the investigator, could be associated with disturbed gastrointestinal absorption (e.g., resections, diverticula, active and diagnostically confirmed irritable bowel syndrome, malabsorption syndrome);
* Presence or history of significant other acute or chronic coexisting illness which, in the opinion of the investigator, could compound the outcome of the study, including but not limited to kidney, liver or renal disease/dysfunction, uncontrolled metabolic disease, atrial fibrillation, syncope and known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts;
* Participant has a cardiac pacemaker;
* Present or recent (within 3-months of screening) use of any other medication which, in the opinion of the investigator, could interfere with the outcome of the study, including but not limited to antithrombotic agents, anti-inflammatory agents and chronic NSAID use (except low-dose prophylactic, proton pump inhibitors (PPIs), antihistamines, if ongoing (3-months) and on a stable dose throughout study period);
* Steroids (over-the-counter (OTC) NSAIDS, topical steroids and inhalers are allowed)
* Current or planned participation in a weight-loss regimen, including extreme dietary practices or exercise;
* Having lost \>5% of their body weight within 3-months prior to screening;
* Participant has a history of drug and/or alcohol abuse at the time of enrolment;
* Participation in a clinical trial with an investigational product within 60 days before screening, or plans to participate in another study during the study period;
* Participant has a history of non-compliance with medical treatments
* Female subjects with a premature onset of menopause ( those aged less than 45 years at onset) or those whose menopause has been brought on early either by intended or unintended pharmacological intervention (resulting from the treatment of other conditions)

Primary outcomes:
measure: 2-hour blood glucose incremental Area Under the Curve (AUC)
timeFrame: From Baseline to Week 12
measure: 2-hour blood insulin incremental AUC
timeFrame: From Baseline to Week 12
measure: Post-prandial insulin sensitivity
timeFrame: From Baseline to Week 12
measure: Glycated haemoglobin (HbA1c)
timeFrame: From Baseline to Week 12
Secondary outcomes:
measure: Glycaemic Variability (GV) over the 24-hr period
timeFrame: From Baseline to Week 12
measure: Glycaemic Control (GC) over the 24-hr period
timeFrame: From Baseline to Week 12
measure: GV during sleeping hours
timeFrame: From Baseline to Week 12
measure: Fasting Blood Glucose
timeFrame: From Baseline to Week 12
measure: Blood Pressure
timeFrame: From Baseline to Week 12
Other outcomes:
measure: Safety Blood Profile
timeFrame: From Baseline to Week 12
measure: Vitals
timeFrame: From Baseline to Week 12
measure: Vitals
timeFrame: From Baseline to Week 12
measure: Adverse Events (AE)
timeFrame: From Baseline to Week 12
Locations:
city: Chicago
country: United States
facility: Atlantia Food Clinical Trials, Chicago
state: Illinois
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
city: Glasgow
country: United Kingdom
facility: CPS Research
state: Scotland
Study officials:
affiliation: Atlantia Food Clinical Trials
name: James Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References: