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Effects of Dietary Fibre on Glucose Metabolism and Satiety

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ClinicalTrials.gov Identifier: NCT02093481
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Jonna Sandberg, Lund University

Brief Summary:
The experimental model is a semi-acute study where the purpose of the study is to evaluate food factors related to colonially derived regulation of glucose metabolism (and related parameters) and satiety in healthy subjects.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Other: Test meal Other: Reference Other: Priming Other: No priming Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intrinsic Indigestible Carbohydrates as Means to Modulate Colonic Events, With Specific Focus on Metabolism and Satiety
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: + ind. CHO + prim
Test meal: ate intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Test meal Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Experimental: - ind. CHO + prim
Reference:ate no intrinsic indigestible carbohydrates 3 days prior to measurements of variables (priming)
Other: Reference Other: Priming
The reference or test meal was eaten 3 days prior to measurements of variables.
Experimental: + ind. CHO - prim
Test meal: ate intrinsic indigestible carbohydrates 1 day prior to measurements of variables (no priming)
Other: Test meal Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.
Experimental: - ind. CHO - prim
Reference: ate no indigestible carbohydrates the day prior to measurements of variables (no priming).
Other: Reference Other: No priming
The reference or test meal was eaten 1 days prior to measurements of variables.



Primary Outcome Measures :
  1. Blood glucose [ Time Frame: Postprandial 0-180 min after breakfast ]
    The test products are both ingested one day and three days prior to measurements of variables.

  2. Insulin [ Time Frame: Postprandial 0-180 min after breakfast ]
    The test products are both ingested one day and three days prior to measurements of variables.

  3. Appetite hormones [ Time Frame: Postprandial 0-180 min after breakfast ]
    The test products are both ingested one day and three days prior to measurements of variables.

  4. Markers of colonic fermentation and inflammation [ Time Frame: Postprandial 0-180 min after breakfast ]
    The test products are both ingested one day and three days prior to measurements of variables.


Secondary Outcome Measures :
  1. Subjective satiety [ Time Frame: Postprandial 0-180 min after breakfast ]
    The measures of hunger, satiety, and desire to eat with the use of a VAS were determined every hour throughout the postprandial testing sessions.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal fasting blood glucose, BMI 19-25 kg/m2

Exclusion Criteria:

  • Gastrointestinal diseases or food allergies e.g. lactose-, gluten intolerance, metabolic disorders e.g. diabetes, tobacco/snuff users. Antibiotic or probiotic usage within two weeks, and during study. Vegetarians.

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): NCT02093481


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonna Sandberg, MSc, postgraduate student, Lund University
ClinicalTrials.gov Identifier: NCT02093481     History of Changes
Other Study ID Numbers: Dnr2013/241
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

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