NCT05417360: Amansia

Akkermansia and Weight Maintenance

Completed NA Last updated 27 November 2023

What this trial tests

NA trial testing Akkermansia muciniphila in Obesity in 90 participants. Completed in 20 November 2023.

Timeline

22 July 2022

Primary endpoint
20 November 2023

20 November 2023

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	90
Start date	22 July 2022
Primary completion	20 November 2023
Estimated completion	20 November 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Akkermansia muciniphila — full drug profile →
• Placebo

Conditions studied

• Obesity — all drugs for Obesity →
• Microtia — all drugs for Microtia →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →
• Weight Loss — all drugs for Weight Loss →

Sponsor

Maastricht University Medical Center

Who can join

Adults 20 to 70, any sex, with Obesity or Microtia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity and related disorders such as type 2 diabetes are a worldwide diet-related problem. As such new treatment options are constantly being developed. Bacteria living in the gut seem to be a key player in the treatment of obesity and related metabolic diseases by influencing energy balance and the immune system. In terms of newly identified bacteria species, Akkermansia muciniphila (A. muciniphila) has been found to be related to obesity. Several animal studies have shown the beneficial impact of A. muciniphila on the treatment of body weight as well as insulin sensitivity.

The growth requirements of live A. muciniphila as well as its oxygen sensitivity rendered this bacterium unsuitable for human investigations or putative therapeutic opportunities. Therefore, pasteurization, a mild heating method, and its impact on diet-induced metabolic disorders in mice were investigated. Unexpectedly, this method of inactivation did not negate the effect of A. muciniphila, but improved its beneficial metabolic effects. Pilot studies have provided further evidence that pasteurization of A. muciniphila is safe for human use and has the potential to beneficially affect the control of body weight and glucose metabolism.

In this project, The investigators hypothesize that pasteurized A. muciniphila will be superior to placebo intervention in maintaining body weight after a phase of weight loss (low caloric diet) in adult participants with overweight or obesity.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Next-Generation Probiotics in Obesity and Obesity-Associated Disorders: Current Knowledge and Future Perspectives.
   Vallianou NG, Kounatidis D, Tsilingiris D, Panagopoulos F, et al · · 2023 · cited 73× · PMID 37047729 · DOI 10.3390/ijms24076755
2. Questioning the foundations of the gut microbiota and obesity.
   Dalby MJ, Dalby MJ. · · 2023 · cited 18× · PMID 37661739 · DOI 10.1098/rstb.2022.0221
3. Pasteurized Akkermansia muciniphila Muc<sup>T</sup> for weight loss maintenance in people with overweight and obesity: a controlled randomized trial.
   Mount S, Canfora EE, Jocken JW, Umanets A, et al · · 2026 · cited 1× · PMID 42120725 · DOI 10.1038/s41591-026-04394-7