Efficacy and Safety of 12-weeks Supplementation of Eubacterium Hallii on Insulin Sensitivity and Glycaemic Control
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glucose Metabolism Disorders
- Impaired Glucose Tolerance
- Insulin Resistance
- Insulin Sensitivity
- Metabolic Syndrome
- Pre Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Only males
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 ...
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 males.
Tracking Information
- NCT #
- NCT04529473
- Collaborators
- Caelus Pharmaceuticals BV
- Investigators
- Principal Investigator: James Ryan, MD Atlantia Food Clinical Trials