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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01718431
First Posted: October 31, 2012
Last Update Posted: May 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elin Johansson, Lund University
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome Other: test meal Other: reference meal Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.

Resource links provided by NLM:


Further study details as provided by Elin Johansson, Lund University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 40
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: indigestible carbohydrates
test meal: indigestible carbohydrates
Other: test meal
Experimental: reference
reference meal: no indigestible carbohydrates
Other: reference meal

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 19-28 kg/m2

Exclusion Criteria:

  • gastrointestinal diseases
  • metabolic disorders
  • tobacco/snuff user
  • antibiotic/probiotic treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718431


Locations
Sweden
Applied Nutrition and Food Chemistry, Lund University
Lund, Sweden, SE-221 00
Sponsors and Collaborators
Lund University
Investigators
Principal Investigator: Anne Nilsson, PhD Lund University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elin Johansson, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT01718431     History of Changes
Other Study ID Numbers: Dnr2010/457 - 3day
First Submitted: October 9, 2012
First Posted: October 31, 2012
Last Update Posted: May 8, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases