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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718431
• Other study ID #: Dnr2010/457 - 3day
• Status: Completed
• Phase: Phase 0
• First received: October 9, 2012
• Last updated: May 7, 2013
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI 19-28 kg/m2

Exclusion Criteria:

• gastrointestinal diseases

• metabolic disorders

• tobacco/snuff user

• antibiotic/probiotic treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Other:
• test meal

• reference meal

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-prandially after breakfast, 0-150 min	No
Secondary	Cognitive performance	The cognitive performance of the test subjects is measured to investigate work memory and specific attention.	Post-prandially after breakfast, 0-210 min	No
Secondary	Subjective satiety	The subjective sensation of satiety, hunger and desire to eat is measured using a questionnaire.	post-prandially after breakfast, 0-150 min	No