NCT02569684

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 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

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

September 29, 2015

Last Update Submit

September 15, 2020

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    six weeks

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Prebiotic fibers: Oligofructose and inulin

Dietary Supplement: Prebiotic fibers: oligofructose and inulin

Arm B

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

Prebiotic fibers: oligofructose and inulinDIETARY_SUPPLEMENT
Arm A
MaltodextrinDIETARY_SUPPLEMENT
Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • IBD
  • IBS
  • Coeliac disease
  • Have used antibiotics within the last two months
  • Have used supplements with prebiotics or probiotics the last two months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (3)

  • 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.

    PMID: 40471453DERIVED

  • Birkeland 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.

    PMID: 34297363DERIVED

  • Birkeland 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.

    PMID: 32440730DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Inulinmaltodextrin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Anne-Marie Aas, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2018

Study Completion

December 1, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)