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

Early Phase 1

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: test meal; Other: reference meal

• Registration Number: NCT01718431
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• BMI 19-28 kg/m2

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
indigestible carbohydrates	test meal	test meal: indigestible carbohydrates
reference	reference meal	reference meal: no indigestible carbohydrates

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of the test meal	Post-prandially after breakfast, 0-150 min	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.

Secondary Outcome Measures

Name	Time	Method
Cognitive performance	Post-prandially after breakfast, 0-210 min	The cognitive performance of the test subjects is measured to investigate work memory and specific attention.
Subjective satiety	post-prandially after breakfast, 0-150 min	The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.

Trial Locations

Locations (1)

Applied Nutrition and Food Chemistry, Lund University; 🇸🇪 Lund, Sweden