Recruitment

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