Diabetes Type 2NCT05689684
Arabinoxylan-oligosaccharides (AXOS) for the Management of Type-2 Diabetes
A study testing AG+XOS+AXOS in people with Diabetes Type 2, run by Lund University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- AG+XOS+AXOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- 7 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hba1c > 60 mmol/L
- fP-triglycerides > 4 mmol/ L - can be included if stabilized by medication
- fP total cholesterol >8 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
Show all 20Show fewer
- alcohol abuse > 40g/d
- chronical 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 degree
- psychological disease of significant degree
- cancer of significant degree
- gastric-bypass operation
- operation planned during the study period
- known gluten intolerance, lactose intolerance, milk protein allergy
- other food allergy
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Biomedical Nutrition, Lund University and Department of Endocrinology , Lund University Hospital
Lund, 221 00
About this study
Official title: Arabinoxylan-oligosaccharides (AXOS) As a Medical Food for Adjuvant Approach in the Management of Type-2 Diabetes
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.
Read the detailed 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.
- Conditions
- Diabetes Type 2
- Being tested
- AG+XOS+AXOS, Placebo Maltodextrin
- Keywords
- AXOS, AG, XOS, metformin, gut microbiome, corn bran extract
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG+XOS+AXOSDietary supplement
4-month parallel randomized controlled study
Placebo MaltodextrinDietary supplement
4-month parallel randomized controlled study
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Product: Aarabinogalactan (AG)+xylan-oligosaccharides (XOS) +AXOS | Active comparator | Daily 2x 5g Hybrid Product, produced by Carbiotix AB. Hybrid Product is available as powder, which can be easily dissolved in water. Receives: Dietary Supplement: AG+XOS+AXOS |
| Placebo | Placebo comparator | Daily 2x 5g maltodextrin. Maltodextrin is available as powder, which can be easily dissolved in water. Receives: Dietary Supplement: Placebo Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in levels of postprandial blood glucose
Postprandial blood glucose will be analysed at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
Secondary outcomes (9)
gastrointestinal symptoms (bloating, abdominal pain, diarrhea, constipation)
Gastrointestinal symptoms will be measured using a questionnaire with a scale 0-5
Measured: 0, 1months, 2months, 3months, 4months
composition and activity of the gut microbiota (genus and species)
Fecal samples will be analysed to measure microbiota composition using high-throughput next-generation sequencing of 16S rRNA amplicons and quantitative PCR
Measured: 0, 2months and 4months
levels of fasting blood glucose
Blood samples will be taken and analysed for glucose at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
level of Hba1c
Blood samples will be taken and analysed for Hba1c at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
blood lipid profile
Blood samples will be taken and analysed for total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
immune functions
Blood samples will be taken and analysed for CRP at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
uptake of vitamin B12 and vitamin D
Blood samples will be taken and analysed for vitamin B12 and vitamin D at the university hospital according to standard analytical procedures
Measured: 0, 2months and 4months
systolic and diastolic blood pressure
Systolic and diastolic blood pressure will be measured twice in sitting position using automatic devices
Measured: 0, 2months and 4months
body weight
Body weight will be measured in kg to the nearest 0,1 kg using a digital scale
Measured: 0, 2months and 4months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start7 Nov 2022
- Primary completion6 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Carbiotix AB, Skane University Hospital, Vinnova
- Responsible party
- Principal investigator, LieseLotte Cloetens, Lund University
- Investigators
- Lieselotte Cloetens, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689684
- Sponsor's protocol ID
- AXOS22
- Other IDs
- 2022-05204
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boll EV, Ekstrom LM, Courtin CM, Delcour JA, Nilsson AC, Bjorck IM, Ostman EM. Effects of wheat bran extract rich in arabinoxylan oligosaccharides and resistant starch on overnight glucose tolerance and markers of gut fermentation in healthy young adults. Eur J Nutr. 2016 Jun;55(4):1661-70. doi: 10.1007/s00394-015-0985-z. Epub 2015 Jul 14.
PubMed 26169871Cloetens L, Broekaert WF, Delaedt Y, Ollevier F, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Tolerance of arabinoxylan-oligosaccharides and their prebiotic activity in healthy subjects: a randomised, placebo-controlled cross-over study. Br J Nutr. 2010 Mar;103(5):703-13. doi: 10.1017/S0007114509992248. Epub 2009 Dec 10.
PubMed 20003568Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
PubMed 28611480McGovern A, Tippu Z, Hinton W, Munro N, Whyte M, de Lusignan S. Comparison of medication adherence and persistence in type 2 diabetes: A systematic review and meta-analysis. Diabetes Obes Metab. 2018 Apr;20(4):1040-1043. doi: 10.1111/dom.13160. Epub 2017 Dec 12.
PubMed 29135080Uusitupa M, Khan TA, Viguiliouk E, Kahleova H, Rivellese AA, Hermansen K, Pfeiffer A, Thanopoulou A, Salas-Salvado J, Schwab U, Sievenpiper JL. Prevention of Type 2 Diabetes by Lifestyle Changes: A Systematic Review and Meta-Analysis. Nutrients. 2019 Nov 1;11(11):2611. doi: 10.3390/nu11112611.
PubMed 31683759
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arabinoxylan-oligosaccharides (AXOS) As a Medical Food for Adjuvant Approach in the Management of Type-2 Diabetes
- ClinicalTrials.gov ID
- NCT05689684
- Acronym / sponsor ID
- AXOS22
- Conditions
- Diabetes Type 2
- Keywords
- AXOS, AG, XOS, metformin, gut microbiome, corn bran extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Carbiotix AB, Skane University Hospital, Vinnova
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Product: Aarabinogalactan (AG)+xylan-oligosaccharides (XOS) +AXOS | Active comparator | Dietary Supplement: AG+XOS+AXOSDaily 2x 5g Hybrid Product, produced by Carbiotix AB. Hybrid Product is available as powder, which can be easily dissolved in water. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo MaltodextrinDaily 2x 5g maltodextrin. Maltodextrin is available as powder, which can be easily dissolved in water. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- Hba1c > 60 mmol/L
- fP-triglycerides > 4 mmol/ L - can be included if stabilized by medication
- fP total cholesterol >8 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG+XOS+AXOS4-month parallel randomized controlled study | Dietary supplement | Hybrid Product: Aarabinogalactan (AG)+xylan-oligosaccharides (XOS) +AXOS |
| Placebo Maltodextrin4-month parallel randomized controlled study | Dietary supplement | Placebo |
Primary outcome
change in levels of postprandial blood glucose
Time frame: 0, 2months and 4months
Postprandial blood glucose will be analysed at the university hospital according to standard analytical procedures
9 secondary outcomes
gastrointestinal symptoms (bloating, abdominal pain, diarrhea, constipation)
Time frame: 0, 1months, 2months, 3months, 4months
composition and activity of the gut microbiota (genus and species)
Time frame: 0, 2months and 4months
levels of fasting blood glucose
Time frame: 0, 2months and 4months
level of Hba1c
Time frame: 0, 2months and 4months
blood lipid profile
Time frame: 0, 2months and 4months
immune functions
Time frame: 0, 2months and 4months
uptake of vitamin B12 and vitamin D
Time frame: 0, 2months and 4months
systolic and diastolic blood pressure
Time frame: 0, 2months and 4months
body weight
Time frame: 0, 2months and 4months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Background: PubMed 26169871Boll EV, Ekstrom LM, Courtin CM, Delcour JA, Nilsson AC, Bjorck IM, Ostman EM. Effects of wheat bran extract rich in arabinoxylan oligosaccharides and resistant starch on overnight glucose tolerance and markers of gut fermentation in healthy young adults. Eur J Nutr. 2016 Jun;55(4):1661-70. doi: 10.1007/s00394-015-0985-z. Epub 2015 Jul 14.
- Background: PubMed 20003568Cloetens L, Broekaert WF, Delaedt Y, Ollevier F, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Tolerance of arabinoxylan-oligosaccharides and their prebiotic activity in healthy subjects: a randomised, placebo-controlled cross-over study. Br J Nutr. 2010 Mar;103(5):703-13. doi: 10.1017/S0007114509992248. Epub 2009 Dec 10.
- Background: PubMed 28611480Gibson GR, Hutkins R, Sanders ME, Prescott SL, Reimer RA, Salminen SJ, Scott K, Stanton C, Swanson KS, Cani PD, Verbeke K, Reid G. Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. Nat Rev Gastroenterol Hepatol. 2017 Aug;14(8):491-502. doi: 10.1038/nrgastro.2017.75. Epub 2017 Jun 14.
- Background: PubMed 29135080McGovern A, Tippu Z, Hinton W, Munro N, Whyte M, de Lusignan S. Comparison of medication adherence and persistence in type 2 diabetes: A systematic review and meta-analysis. Diabetes Obes Metab. 2018 Apr;20(4):1040-1043. doi: 10.1111/dom.13160. Epub 2017 Dec 12.
- Background: PubMed 31683759Uusitupa M, Khan TA, Viguiliouk E, Kahleova H, Rivellese AA, Hermansen K, Pfeiffer A, Thanopoulou A, Salas-Salvado J, Schwab U, Sievenpiper JL. Prevention of Type 2 Diabetes by Lifestyle Changes: A Systematic Review and Meta-Analysis. Nutrients. 2019 Nov 1;11(11):2611. doi: 10.3390/nu11112611.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieselotte Cloetens principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AG+XOS+AXOS in people with Diabetes Type 2, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in levels of postprandial blood glucose (time frame: 0, 2months and 4months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689684, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.