Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control

NCT04529473 | Completed

• 1 other identifier: AFCRO-115
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Pre Diabetes; Impaired Glucose Tolerance; Insulin Sensitivity; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• 2-hour blood glucose incremental Area Under the Curve (AUC)

  as measured by standard Oral Glucose Tolerance Test (OGTT)

  From Baseline to Week 12

• 2-hour blood insulin incremental AUC

  as measured by standard OGTT

  From Baseline to Week 12

• Post-prandial insulin sensitivity

  as measured by insulin sensitivity index-OGTT (ISI-OGTT)

  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

  From Baseline to Week 12

Secondary Outcomes (5)

• Glycaemic Variability (GV) over the 24-hr period

  From Baseline to Week 12

• Glycaemic Control (GC) over the 24-hr period

  From Baseline to Week 12

• GV during sleeping hours

  From Baseline to Week 12

• Fasting Blood Glucose

  From Baseline to Week 12

• Blood Pressure

  From Baseline to Week 12

Other Outcomes (4)

• Safety Blood Profile

  From Baseline to Week 12

• Vitals

  From Baseline to Week 12

• Vitals

  From Baseline to Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 capsule per day, consumed orally, before breakfast for the duration of the study.

Other: Placebo

Eubacterium hallii

EXPERIMENTAL

1 capsule per day, consumed orally, before breakfast for the duration of the study.

Dietary Supplement: Eubacterium hallii

Interventions

Eubacterium hallii DIETARY_SUPPLEMENT

Eubacterium hallii, ≥ 1x10\^9 live bacterial cells (per capsule)

Eubacterium hallii

Placebo OTHER

Placebo capsules are identical to the active treatment

Placebo

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Atlantia Food Clinical Trials: lead
• Caelus Pharmaceuticals BV: collaborator

Study Sites (3)

Atlantia Food Clinical Trials, Chicago

Chicago, Illinois, 60611, United States

Location

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

CPS Research

Glasgow, Scotland, G20 0XA, United Kingdom

Location

Related Publications (1)

• Attaye I, Bird JK, Nieuwdorp M, Gul S, Seegers JFML, Morrison S, Hofkens S, Herrema H, Bui N, Puhlmann ML, de Vos WM. Anaerobutyricum soehngenii improves glycemic control and other markers of cardio-metabolic health in adults at risk of type 2 diabetes. Gut Microbes. 2025 Dec;17(1):2504115. doi: 10.1080/19490976.2025.2504115. Epub 2025 May 15.

  PMID: 40371708 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance; Glucose Metabolism Disorders; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperglycemia; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Officials

• James Ryan, MD

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 27, 2020
• Study Start: February 3, 2021
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

GB (1); IE (1); US (1)