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Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Effects of Prebiotics on GLP-1 in Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02569684
Enrollment
37
Registered
2015-10-07
Start date
2015-10-31
Completion date
2019-12-31
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

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.

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.

Interventions

DIETARY_SUPPLEMENTPrebiotic fibers: oligofructose and inulin
DIETARY_SUPPLEMENTMaltodextrin

Sponsors

Norwegian Diabetes Association
CollaboratorOTHER
Norwegian Extra Foundation for Health and Rehabilitation
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in plasma GLP-1 in response to standardized test meal before and after six weeks of ingestion of prebiotic fibers or placebosix weeksThe 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026