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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elin Johansson, Lund University
ClinicalTrials.gov Identifier:
NCT01718431
First received: October 9, 2012
Last updated: May 7, 2013
Last verified: May 2013
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Elin Johansson, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT01718431     History of Changes
Other Study ID Numbers: Dnr2010/457 - 3day
Study First Received: October 9, 2012
Last Updated: May 7, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014