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Arabinoxylan-oligosaccharides (AXOS) for the Management of Type-2 Diabetes

NCT05689684 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-03-10

No results posted yet for this study

Summary

The project aims to achieve significantly improved clinical care for type 2 diabetes. The current standard treatment metformin has low adherence due to its main side effect gut dysbiosis, which also results in more complications and high overall costs. Prebiotics have been suggested as a medical food and might be helpful as adjuvant management in type 2 diabetes and other metabolic diseases. Carbiotix AB has developed, a corn fiber extract containing arabinoxylan-oligosaccharides (AXOS), which have great potential for improving gut health. In this project, it will be investigated whether the intake of a hybrid product containing AXOS together with metformin can significantly improve glucose metabolism and gut health in patients with type 2 diabetes.

Conditions

  • Diabetes Type 2

Interventions

DIETARY_SUPPLEMENT

AG+XOS+AXOS

4-month parallel randomized controlled study

DIETARY_SUPPLEMENT

Placebo Maltodextrin

4-month parallel randomized controlled study

Sponsors & Collaborators

  • Carbiotix AB

    collaborator INDUSTRY

  • Skane University Hospital

    collaborator OTHER

  • Vinnova

    collaborator OTHER_GOV

  • Lund University

    lead OTHER

Principal Investigators

  • Lieselotte Cloetens · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-07
Primary Completion
2023-10-06
Completion
2024-12-31

Countries

  • Sweden

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 NCT05689684 on ClinicalTrials.gov