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Recruiting
NCT05689684
Arabinoxylan-oligosaccharides (AXOS) for the Management of Type-2 Diabetes
Conditions: Diabetes Type 2
Sex: All
Ages: 50 Years – 80 Years
Phase: NA
Enrollment: 100
Sponsor: Lund University
Location: Sweden
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.
Eligibility Criteria
Inclusion Criteria:Males and females with T2D and taking metformin as treatment for at least 6 monthsAge 50-80 years, at the time of signing the informed consentBMI 25-40 kg/m2Stable body weight (less than 5% difference during the last 3 months)Willing and able to give written informed consent for participating the studyWilling to comply with all study proceduresExclusion Criteria:Hba1c > 60 mmol/LfP-triglycerides > 4 mmol/ L - can be included if stabilized by medicationfP total cholesterol >8 mmol/L - can be included if stabilized by medicationhigh blood pressure >160/90 mmHg - can be included if stabilized by medicationintake of antibiotics within 4 weeks prior to the start of the studyregular intake of probiotics and/or prebiotics within 4 weeks prior to the start of the studyalcohol abuse > 40g/dchronical disease (liver, kidney)gastrointestinal disease (ulcerative colitis, Crohn's disease, irritable bowel syndrome)heart disease (within the last 12 months)treatment with corticosteroids of significant degreepsychological disease of significant degreecancer of significant degreegastric-bypass operationoperation planned during the study periodknown gluten intolerance, lactose intolerance, milk protein allergyother food allergyspecial diet (e.g.
vegetarian, vegan, LCHF, 5-2)non-Swedish speaking and readinginvestigator considers the subject unlikely to comply with the study procedures, restrictions, and requirements
Source: ClinicalTrials.gov (NCT05689684). StuddyBuddy aggregates publicly available trial information.