NCT05689684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 10, 2025

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 21, 2022

Last Update Submit

March 5, 2025

Conditions

Diabetes Type 2

Keywords

AXOSAGXOSmetformingut microbiomecorn bran extract

Outcome Measures

Primary Outcomes (1)

  • change in levels of postprandial blood glucose

    Postprandial blood glucose will be analysed at the university hospital according to standard analytical procedures

    0, 2months and 4months

Secondary Outcomes (9)

  • gastrointestinal symptoms (bloating, abdominal pain, diarrhea, constipation)

    0, 1months, 2months, 3months, 4months

  • composition and activity of the gut microbiota (genus and species)

    0, 2months and 4months

  • levels of fasting blood glucose

    0, 2months and 4months

  • level of Hba1c

    0, 2months and 4months

  • blood lipid profile

    0, 2months and 4months

  • +4 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: AG+XOS+AXOS

Placebo

PLACEBO COMPARATOR

Daily 2x 5g maltodextrin. Maltodextrin is available as powder, which can be easily dissolved in water.

Dietary Supplement: Placebo Maltodextrin

Interventions

AG+XOS+AXOSDIETARY_SUPPLEMENT

4-month parallel randomized controlled study

Hybrid Product: Aarabinogalactan (AG)+xylan-oligosaccharides (XOS) +AXOS
Placebo MaltodextrinDIETARY_SUPPLEMENT

4-month parallel randomized controlled study

Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomedical Nutrition, Lund University and Department of Endocrinology , Lund University Hospital

Lund, 221 00, Sweden

Location

Related Publications (5)

  • 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.

    PMID: 26169871BACKGROUND

  • Cloetens 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.

    PMID: 20003568BACKGROUND

  • Gibson 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.

    PMID: 28611480BACKGROUND

  • McGovern 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.

    PMID: 29135080BACKGROUND

  • Uusitupa 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.

    PMID: 31683759BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Lieselotte Cloetens

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 19, 2023

Study Start

November 7, 2022

Primary Completion

October 6, 2023

Study Completion

December 31, 2024

Last Updated

March 10, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)