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

May 7, 2013 updated by: Elin Johansson, Lund University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-221 00
        • Applied Nutrition and Food Chemistry, Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 19-28 kg/m2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: indigestible carbohydrates
test meal: indigestible carbohydrates
Other: test meal
EXPERIMENTAL: reference
reference meal: no indigestible carbohydrates
Other: reference meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC) of the test meal
Time Frame: 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.
Post-prandially after breakfast, 0-150 min

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr2010/457 - 3day

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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