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

NCT05114018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Metabolic Syndrome
  • Pre-diabetes
  • Overweight and Obesity

Interventions

DIETARY_SUPPLEMENT

Pasteurized A. muciniphila

Daily oral dose

DIETARY_SUPPLEMENT

placebo

Placebo = identical to verum regarding the form, size, taste, color and intake

Sponsors & Collaborators

  • A-Mansia Biotech S.A.

    lead INDUSTRY

Principal Investigators

  • Peter Suenaert, MD, PhD · R&D and Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2023-07-28
Completion
2023-08-31

Countries

  • Germany
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05114018 on ClinicalTrials.gov