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

Early Phase 1CompletedNCT01718431

Lund University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Metabolic Syndrome

Interventions

test mealOTHER

reference mealOTHER

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI 19-28 kg/m2 Exclusion Criteria: * gastrointestinal diseases * metabolic disorders * tobacco/snuff user * antibiotic/probiotic treatment

Locations (1)

Applied Nutrition and Food Chemistry, Lund University

Lund, Sweden

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve (AUC) of the test meal

The 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.

Time frame: Post-prandially after breakfast, 0-150 min

Secondary Outcomes

Cognitive performance

The cognitive performance of the test subjects is measured to investigate work memory and specific attention.

Time frame: Post-prandially after breakfast, 0-210 min

Subjective satiety

The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.

Time frame: post-prandially after breakfast, 0-150 min

Data from ClinicalTrials.gov

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