NCT05114018

Effect of Pasteurized Akkermansia Muciniphila on Insulin Resistance in Otherwise Healthy Subjects With Dysglycaemia

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effects of 'Next Generation Beneficial Microbes', Akkermansia Muciniphila (AMF-01), on Long-term Improvements in Insulin Resistance in Otherwise Healthy Hyperglycaemic Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: A-Mansia Biotech S.A. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety. Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome. In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.

Detailed description

Overweight and obesity have reached worldwide epidemic level. Observation of elevated glycaemia like impaired fasting glucose and impaired glucose tolerance are reflecting pre-diabetic states often occurring in the context of development of insulin resistance in persons with metabolic syndrome. Moreover, this status is associated with the risk for developing type 2 diabetes as well as cardiovascular disease. In a proof of concept study the supplementation with A. muciniphila was safe and improved metabolic health in persons with metabolic syndrome. The purpose of this study is to demonstrate the efficacy of pasteurized Akkermansia muciniphila (pAKK) in improving insulin sensitivity in hyperglycaemic, but otherwise healthy persons with metabolic syndrome. This is the primary objective of this study. Secondary objectives consist of evaluation of the effects of next generation beneficial microbes on metabolic health, anthropometry and body composition, and safety. Therefore, the trial is designed as a phase 2, randomized, double-blind, placebo-controlled, parallel group, multi-center trial comparing pAKK with placebo in restoring insulin sensitivity in dysglycaemic but otherwise healthy subjects with metabolic syndrome. In total, 144 enrolled participants will attend 6 study visits in total. Study visits may be conducted in the clinic, at home by a Healthcare Professional, or by telephone / telemedicine.

Conditions

• Metabolic Syndrome
• Pre-diabetes
• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pasteurized A. muciniphila	Daily oral dose
DIETARY_SUPPLEMENT	placebo	Placebo = identical to verum regarding the form, size, taste, color and intake

Timeline

• Start date: 2020-06-24
• Primary completion: 2023-07-28
• Completion: 2023-08-31
• First posted: 2021-11-09
• Last updated: 2025-06-08

Locations

2 sites across 2 countries: Germany, Ireland