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

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. Identifier: NCT01718431
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : May 8, 2013
Information provided by (Responsible Party):
Elin Johansson, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: test meal Other: reference meal Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : October 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: indigestible carbohydrates
test meal: indigestible carbohydrates
Other: test meal
Experimental: reference
reference meal: no indigestible carbohydrates
Other: reference meal

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

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

Inclusion Criteria:

  • BMI 19-28 kg/m2

Exclusion Criteria:

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

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 identifier (NCT number): NCT01718431

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

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

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