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

Diabetes Type 2 Clinical Trial

Official title: Arabinoxylan-oligosaccharides (AXOS) as a Medical Food for Adjuvant Approach in the Management of Type-2 Diabetes

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

The prevalence of type 2 diabetes (T2D) is a high prevalence and the leading cause of death and disability worldwide. The quality of life is significantly decreased in these patients and the costs for medical care are enormous. T2D patients are often treated with metformin, but adherence to the treatment is relatively poor, with gut dysbiosis as a major cause. Gut dysbiosis has not been addressed in the clinical setting although numerous studies support its role in disease development. There is an urgent need to improve existing treatments with metformin to improve adherence to drug therapy and the management of the disease. Prebiotics are dietary fibers that stimulate the growth and activity of beneficial gut microbiota. Prebiotics has been suggested as a medical food and might be very useful as an effective adjuvant approach in the management of T2D and other metabolic diseases. Carbiotix AB, a biotech company based in Lund, has developed a corn fiber extract containing arabinoxylan-oligosaccharides (AXOS), which have great potential for improving gut health.

In this project, a clinical trial will be performed to investigate whether the corn fiber extract can significantly increase metformin adherence with improved gut health and glucose metabolism in patients with T2D. To maximize the potential efficacy of the intervention, a "Hybrid Product" containing arabinogalactan (AG), xylan-oligosaccharides (XOS), and AXOS will be used, building on the XOS and AXOS naturally present in the corn fiber extract.

One hundred subjects with T2D and treated with metformin will be recruited for this blind parallel randomized controlled intervention study. After a screening visit, the subjects will be randomized to test the Hybrid Product or placebo (maltodextrin) group. The duration of the intervention is 4 months, and the study subjects will be asked to consume the Hybrid Product or placebo daily (2x 5g). At the start, of week 8 and week 16, the study subjects will visit the study center for the measurement of body weight, waist circumference, and blood pressure. At these 3 visits, fasting blood samples are taken for analysis of glucose and insulin metabolism, blood lipids, and inflammation markers. Fecal samples are also collected to investigate the effect of the Hybrid Product on microbiota composition. At regular times during the study, the subjects must do a 7-point blood glucose monitoring and fill in questionnaires about gastrointestinal symptoms. During the whole study period, all subjects are contacted regularly to follow up on their health status.

If the Hybrid Product shows the strong potential to improve adherence to metformin treatment, this will lead to improving diabetes care with reduced economic consequences. The promotion of a healthy gut by consumption of soluble fibers also helps to support immune function, blood sugar regulation, increased nutrient uptake (e.g. vitamin B12), and better body weight control. These health benefits will undoubtedly result in better well-being in private and working life and thus in a significantly improved quality of life for patients with T2D. Furthermore, effective treatment of T2D will also reduce the prevalence of cardiovascular risk factors, which are key targets in the current public health debate. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

• NCT number: NCT05689684
• Study type: Interventional
• Source: Lund University
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2022
• Completion date: December 31, 2025