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Dietary Fibre and Metabolic Benefits

Validation of a New Antidiabetic Food Concept Based on Modulation of the Gut Microbiota

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03423381
Enrollment
18
Registered
2018-02-06
Start date
2018-05-30
Completion date
2019-02-28
Last updated
2019-03-25

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

Conditions

Glucose Tolerance

Brief summary

The aim of the project is to study the connection between bacterial fermentation in the colon of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans

Detailed description

The purpose with this project is to study the association between bacterial fermentation in the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and appetite regulation. For this purpose, short term studies are performed in healthy adult subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be studied, as well as effects of different processing of the cereals. Cardiometabolic test markers and colonic fermentation metabolites will be followed up to 14 h after intake of the test substrates, and gut microbiota composition will be determined prior to and after the interventions.

Interventions

OTHERCereal product 1

Cereal products based on rye, barley, wheat, oat, and corn

OTHERCereal product 2

Cereal products based on rye, barley, wheat, oat, and corn

OTHERCereal product 3

Cereal products based on rye, barley, wheat, oat, and corn

OTHERCereal product 4

Cereal products based on rye, barley, wheat, oat, and corn

OTHERCereal product 5

Cereal products based on rye, barley, wheat, oat, and corn

OTHERControl product

A cereal based product with low concentrations of df

Sponsors

Vinnova
CollaboratorOTHER_GOV
Öste Venture AB
CollaboratorUNKNOWN
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention model description

Crossover randomised

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy adults * BMI\<30 * non smokers * consuming a non-vegetarian diet that follows the Nordic guidances

Exclusion criteria

* fasting blood glucose \>6.1 mmol/L * known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome), gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies. Further no antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Design outcomes

Primary

MeasureTime frameDescription
Blood glucose regulation0-14 h after intakePostprandial blood glucose regulation (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.

Secondary

MeasureTime frameDescription
plasma GLP-20-14 h after intakegut hormone involved in gut mucosa integrity
plasma adiponectin0-14 h after intakehormone involved in metabolic regulation
plasma BDNF (Brain-derived neurotrophic factor)0-14 h after intakesignal protein important for brain functions, but also involved in metabolic regulation
plasma neurotensin0-14 h after intakea neuro peptide peptides involved in appetite and metabolic regulation
plasma Nesfatin-10-14 h after intakea neuro peptide that participates in the regulation of hunger and fat storage.
serum insulin0-14 h after intakePostprandial serum insulin concentrations (incremental area under the curve) acute after intake of the test products and at forthcoming meals within 14 h after consumption of test products.
gut microbiota compositionfirst stool delivered from14 h after intakeeffects on gut microbiota composition after intake of prebiotics
plasma GLP-1 (glucagon-like peptide-1 ), PYY (peptide tyrosine tyrosine), Ghrelin0-14 h after intakeGastro-intestinale hormones involved in appetite and metabolic regulation
plasma: CRP (C reactive protein ), IL (interleukin)-6, IL-18, IL-8, IL-1, IL-10, LBP (lipopolysaccharide-binding protein), (PAI-1plasminogen activator inhibitor)0-14 h after intakeInflammatory markers in blood
plasma SCFA (short-chain fatty acid)0-14 h after intakecolonic fermentation metabolites
blood lipids0-14 h after intakecholesterol and free fatty acids in plasma

Other

MeasureTime frameDescription
Energy intake4 h after intake of a test product or the control productad libitum intake at a second meal after intake of test products
breath hydrogen concentrations0-14 h after intakeindicator of gut fermentation
Subjective appetite sensations0-14 h after intakedetermined with VAS (visual analogue scale) scales (0-100 mm)
mood (valence and activity)0-14 h after intakedetermined with VAS scales (0-100 mm)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026