NCT05689684Completed
Arabinoxylan-oligosaccharides (AXOS) for the Management of Type-2 Diabetes
Arabinoxylan-oligosaccharides (AXOS) As a Medical Food for Adjuvant Approach in the Management of Type-2 Diabetes
Source: ClinicalTrials.gov · Last updated 10 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 21 Dec 2022
- Start date
- 7 Nov 2022
- Primary completion date
- 6 Oct 2023
- Lead sponsor
- Lund University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05689684
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 7 Nov 2022 to the primary completion date, 6 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- fP-triglycerides \> 4 mmol/ L - can be included if stabilized by medication
- high blood pressure \>160/90 mmHg - can be included if stabilized by medication
- intake of antibiotics within 4 weeks prior to the start of the study
- regular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the study
- treatment with corticosteroids of significant degree
Other illness
- chronical disease (liver, kidney)
- gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome)
- heart disease (within the last 12 months)
- psychological disease of significant degree
- cancer of significant degree
- known gluten intolerance, lactose intolerance, milk protein allergy
- other food allergy
Lab values
- Hba1c \> 60 mmol/L
- fP total cholesterol \>8 mmol/L - can be included if stabilized by medication
Other
- alcohol abuse \> 40g/d
- gastric-bypass operation
- operation planned during the study period
- special diet (e.g. vegetarian, vegan, LCHF, 5-2)
- non-Swedish speaking and reading
- investigator considers the subject unlikely to comply with the study procedures, restrictions, and requirements
Who the study is looking for
- Males and females with T2D and taking metformin as treatment for at least 6 months
- Age 50-80 years, at the time of signing the informed consent
- BMI 25-40 kg/m2
- Stable body weight (less than 5% difference during the last 3 months)
- Willing and able to give written informed consent for participating the study
- Willing to comply with all study procedures
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Biomedical Nutrition, Lund University and Department of Endocrinology , Lund University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.