Diabetes Type 2NCT02569684
Effects of Prebiotics on GLP-1 in Type 2 Diabetes
A study testing Prebiotic fibers: oligofructose and inulin and Maltodextrin in people with Diabetes Type 2, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Prebiotic fibers: oligofructose and inulin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes type 2
- BMI 18,5 - 40
- Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
- Moderate intake of alcohol
- Not excessive exercise
- Less than 3 kg weight change the last two months
- Intake of less than 30 g dietary fiber per day
Who cannot join
- IBD
- IBS
- Coeliac disease
- Have used antibiotics within the last two months
- Have used supplements with prebiotics or probiotics the last two months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.
Read the detailed description
We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.
- Conditions
- Diabetes Type 2
- Being tested
- Prebiotic fibers: oligofructose and inulin, Maltodextrin
- 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.
Prebiotic fibers: oligofructose and inulinDietary supplement
MaltodextrinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Prebiotic fibers: Oligofructose and inulin Receives: Dietary Supplement: Prebiotic fibers: oligofructose and inulin |
| Arm B | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo
The changes in GLP-1 response to either prebiotic fibers or placebo will be compared in a cross-over manner where the participants are their own controls. In between the intervention periods there will be a wash-out period of 4 weeks.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Oslo University HospitalThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Diabetes Association, Norwegian Extra Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Anne-Marie Aas, Oslo University Hospital
- Investigators
- Anne-Marie Aas, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569684
- Sponsor's protocol ID
- 1180 REK
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Individual data sharing
- No
Publications
Birkeland E, Bamigbetan WA, Molven KD, Thorsby PM, Gulseth HL, Aas AM, Dahl C. Can supplements with prebiotic fibres positively influence bone health in type 2 diabetes? Insights from a randomised controlled crossover trial. Arch Osteoporos. 2025 Jun 5;20(1):71. doi: 10.1007/s11657-025-01556-x.
PubMed 40471453Birkeland E, Gharagozlian S, Gulseth HL, Birkeland KI, Hartmann B, Holst JJ, Holst R, Aas AM. Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. Diabet Med. 2021 Oct;38(10):e14657. doi: 10.1111/dme.14657. Epub 2021 Aug 7.
PubMed 34297363Birkeland E, Gharagozlian S, Birkeland KI, Valeur J, Mage I, Rud I, Aas AM. Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial. Eur J Nutr. 2020 Oct;59(7):3325-3338. doi: 10.1007/s00394-020-02282-5. Epub 2020 May 21.
PubMed 32440730
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prebiotics on GLP-1 in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02569684
- Acronym / sponsor ID
- 1180 REK
- Conditions
- Diabetes Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Diabetes Association, Norwegian Extra Foundation for Health and Rehabilitation
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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 aim of the study is to compare the effects of prebiotics versus placebo on blood concentrations of glucagon-like peptide-1 in subjects with diabetes type 2.
Detailed description
We looked at 6 weeks supplementation with a prebiotic fibre mix of inulin and FOS. Cross over design compared to maltodextrin as placebo. Additional outcome measures: blood glucose, insulin, GLP-2, ghrelin, PYY and leptin after a standardized mixed meal test. Also measured changes in microbiota composition and SCFA in feces before and after intervention/placebo periods, and subjective measures of appetite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Dietary Supplement: Prebiotic fibers: oligofructose and inulinPrebiotic fibers: Oligofructose and inulin |
| Arm B | Placebo comparator | Dietary Supplement: MaltodextrinMaltodextrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diabetes type 2
- BMI 18,5 - 40
- Not medicated with insulin, GLP-1 analogues or DPP4 inhibitors
- Moderate intake of alcohol
- Not excessive exercise
Key exclusion criteria (6 listed)
- IBD
- IBS
- Coeliac disease
- Have used antibiotics within the last two months
- Have used supplements with prebiotics or probiotics the last two months
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 |
|---|---|---|
| Prebiotic fibers: oligofructose and inulin | Dietary supplement | Arm A |
| Maltodextrin | Dietary supplement | Arm B |
Primary outcome
Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo
Time frame: six weeks
The changes in GLP-1 response to either prebiotic fibers or placebo will be compared in a cross-over manner where the participants are their own controls. In between the intervention periods there will be a wash-out period of 4 weeks.
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 16 Sep 2020.
- Derived from this study: PubMed 40471453Birkeland E, Bamigbetan WA, Molven KD, Thorsby PM, Gulseth HL, Aas AM, Dahl C. Can supplements with prebiotic fibres positively influence bone health in type 2 diabetes? Insights from a randomised controlled crossover trial. Arch Osteoporos. 2025 Jun 5;20(1):71. doi: 10.1007/s11657-025-01556-x.
- Derived from this study: PubMed 34297363Birkeland E, Gharagozlian S, Gulseth HL, Birkeland KI, Hartmann B, Holst JJ, Holst R, Aas AM. Effects of prebiotics on postprandial GLP-1, GLP-2 and glucose regulation in patients with type 2 diabetes: A randomised, double-blind, placebo-controlled crossover trial. Diabet Med. 2021 Oct;38(10):e14657. doi: 10.1111/dme.14657. Epub 2021 Aug 7.
- Derived from this study: PubMed 32440730Birkeland E, Gharagozlian S, Birkeland KI, Valeur J, Mage I, Rud I, Aas AM. Prebiotic effect of inulin-type fructans on faecal microbiota and short-chain fatty acids in type 2 diabetes: a randomised controlled trial. Eur J Nutr. 2020 Oct;59(7):3325-3338. doi: 10.1007/s00394-020-02282-5. Epub 2020 May 21.
- 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.
Anne-Marie Aas, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic fibers: oligofructose and inulin and Maltodextrin in people with Diabetes Type 2, run by Oslo University Hospital at 1 site in Norway.
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 7 inclusion and 6 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 16 Sep 2020. 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 Norway. 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?
Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebo (time frame: six weeks). 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 NCT02569684, which also lists 3 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 16 Sep 2020.