NCT04529473

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Atlantia Food Clinical Trials · Industry
• Sex: All
• Age: 21 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Eubacterium hallii	Eubacterium hallii, ≥ 1x10\^9 live bacterial cells (per capsule)
OTHER	Placebo	Placebo capsules are identical to the active treatment

Timeline

• Start date: 2021-02-03
• Primary completion: 2022-08-23
• Completion: 2022-08-23
• First posted: 2020-08-27
• Last updated: 2022-11-15

Locations

3 sites across 3 countries: United States, Ireland, United Kingdom