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Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01718431
Enrollment
40
Registered
2012-10-31
Start date
2010-10-31
Completion date
2013-03-31
Last updated
2013-05-08

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

Conditions

Metabolic Syndrome

Brief summary

This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.

Interventions

OTHERtest meal

Sponsors

Lund University
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

* BMI 19-28 kg/m2

Exclusion criteria

* gastrointestinal diseases * metabolic disorders * tobacco/snuff user * antibiotic/probiotic treatment

Design outcomes

Primary

MeasureTime frameDescription
Area under the plasma concentration versus time curve (AUC) of the test mealPost-prandially after breakfast, 0-150 minThe differences in AUC between different risk markers, assessed in plasma or serum,after intake of the test meal in comparison to the reference meal is measured. Example of variables measured are glucose, insulin, appetite hormones, inflammatory markers, markers of colonic fermentation.

Secondary

MeasureTime frameDescription
Cognitive performancePost-prandially after breakfast, 0-210 minThe cognitive performance of the test subjects is measured to investigate work memory and specific attention.
Subjective satietypost-prandially after breakfast, 0-150 minThe subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.

Countries

Sweden

Outcome results

None listed

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