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

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ClinicalTrials.gov Identifier: NCT05689684
Recruitment Status : Recruiting
First Posted : January 19, 2023
Last Update Posted : January 19, 2023
Sponsor:
Collaborators:
Carbiotix AB
Skane University Hospital
Vinnova
Information provided by (Responsible Party):
LieseLotte Cloetens, Lund University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Dietary Supplement: AG+XOS+AXOS Dietary Supplement: Placebo Maltodextrin Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Arabinoxylan-oligosaccharides (AXOS) as a Medical Food for Adjuvant Approach in the Management of Type-2 Diabetes
Actual Study Start Date : November 7, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hybrid Product: Aarabinogalactan (AG)+xylan-oligosaccharides (XOS) +AXOS
Daily 2x 5g Hybrid Product, produced by Carbiotix AB. Hybrid Product is available as powder, which can be easily dissolved in water.
 Dietary Supplement: AG+XOS+AXOS
4-month parallel randomized controlled study
Placebo Comparator: Placebo
Daily 2x 5g maltodextrin. Maltodextrin is available as powder, which can be easily dissolved in water.
 Dietary Supplement: Placebo Maltodextrin
4-month parallel randomized controlled study


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. gastrointestinal symptoms (bloating, abdominal pain, diarrhea, constipation) [ Time Frame: 0, 1months, 2months, 3months, 4months ]
    Gastrointestinal symptoms will be measured using a questionnaire with a scale 0-5

  2. composition and activity of the gut microbiota (genus and species) [ Time Frame: 0, 2months and 4months ]
    Fecal samples will be analysed to measure microbiota composition using high-throughput next-generation sequencing of 16S rRNA amplicons and quantitative PCR

  3. levels of fasting blood glucose [ Time Frame: 0, 2months and 4months ]
    Blood samples will be taken and analysed for glucose at the university hospital according to standard analytical procedures

  4. level of Hba1c [ Time Frame: 0, 2months and 4months ]
    Blood samples will be taken and analysed for Hba1c at the university hospital according to standard analytical procedures

  5. blood lipid profile [ Time Frame: 0, 2months and 4months ]
    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

  6. immune functions [ Time Frame: 0, 2months and 4months ]
    Blood samples will be taken and analysed for CRP at the university hospital according to standard analytical procedures

  7. uptake of vitamin B12 and vitamin D [ Time Frame: 0, 2months and 4months ]
    Blood samples will be taken and analysed for vitamin B12 and vitamin D at the university hospital according to standard analytical procedures

  8. systolic and diastolic blood pressure [ Time Frame: 0, 2months and 4months ]
    Systolic and diastolic blood pressure will be measured twice in sitting position using automatic devices

  9. body weight [ Time Frame: 0, 2months and 4months ]
    Body weight will be measured in kg to the nearest 0,1 kg using a digital scale


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05689684


Contacts
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Contact: Lieselotte Cloetens +46 708 63 13 46 lieselotte.cloetens@tbiokem.lth.se
Contact: Sumedha Aradhya +46764963920 sumedha.aradhya@carbiotix.com

Locations
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Sweden
Biomedical Nutrition, Lund University and Department of Endocrinology , Lund University Hospital Recruiting
Lund, Sweden, 221 00
Contact: Lieselotte Cloetens, PhD    0046 462223853    lieselotte.cloetens@tbiokem.lth.se   
Sponsors and Collaborators
Lund University
Carbiotix AB
Skane University Hospital
Vinnova
Investigators
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Principal Investigator: Lieselotte Cloetens Lund University
More Information
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Publications:

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Responsible Party: LieseLotte Cloetens, Senior Lecturer, Lund University
ClinicalTrials.gov Identifier: NCT05689684    
Other Study ID Numbers: AXOS22
2022-05204 ( Other Grant/Funding Number: Vinnova )
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LieseLotte Cloetens, Lund University:
AXOS
AG
XOS
 metformin
gut microbiome
corn bran extract
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases